Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT01083758
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2010-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctr.disclosure@leo-pharma.com', 'phone': '+45 4494 5888', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': "LEO acknowledges the investigators' right to publish the results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to this paper being submitted for publication/presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp', 'otherNumAtRisk': 31, 'otherNumAffected': 10, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout trial, up to 8 weeks', 'description': 'Adverse events for which the investigator did not describe the causal relationship to IP as not related', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)'}, {'type': 'SECONDARY', 'title': 'Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '15.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4', 'description': 'Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 8', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'PRIMARY', 'title': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 4', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'PRIMARY', 'title': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 8', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'PRIMARY', 'title': 'Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.087', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4', 'description': 'Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'spread': '0.087', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.090', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '2.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4', 'description': 'Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.', 'unitOfMeasure': 'mmol/24h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '2.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.', 'unitOfMeasure': 'mmol/24h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '2.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.', 'unitOfMeasure': 'mmol/24h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.179', 'spread': '1.848', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4', 'description': 'Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.', 'unitOfMeasure': 'mmol/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.005', 'spread': '2.379', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.', 'unitOfMeasure': 'mmol/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '0.096', 'spread': '2.142', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.', 'unitOfMeasure': 'mmol/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 2', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 4', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 8', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.0', 'spread': '31.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 2', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.8', 'spread': '29.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 4', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.2', 'spread': '33.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.2', 'spread': '35.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 2', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.", 'unitOfMeasure': '% of participants w/ controlled disease', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 4', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.", 'unitOfMeasure': '% of participants w/ controlled disease', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 8', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.", 'unitOfMeasure': '% of participants w/ controlled disease', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.", 'unitOfMeasure': '% of participants w/ controlled disease', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Start date: 12 April 2010 Completion date: 8 August 2012', 'preAssignmentDetails': 'Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LEO 80185 Gel', 'description': 'Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'dispFirstSubmitDate': '2013-11-22', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2010-03-08', 'dispFirstSubmitQcDate': '2013-11-22', 'resultsFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2010-03-09', 'dispFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-07', 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Adverse Drug Reactions (ADRs)', 'timeFrame': 'Throughout trial, up to 8 weeks', 'description': 'Adverse events for which the investigator did not describe the causal relationship to IP as not related'}, {'measure': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4', 'timeFrame': 'Week 4', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.'}, {'measure': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8', 'timeFrame': 'week 8', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.'}, {'measure': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.', 'timeFrame': 'week 4', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.'}, {'measure': 'Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.', 'timeFrame': 'week 8', 'description': 'Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.'}, {'measure': 'Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'timeFrame': 'Baseline and week 4', 'description': 'Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.'}, {'measure': 'Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'timeFrame': 'Baseline and week 8', 'description': 'Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.'}, {'measure': 'Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.'}, {'measure': 'Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'timeFrame': 'Baseline and week 4', 'description': 'Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.'}, {'measure': 'Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'timeFrame': 'Baseline and week 8', 'description': 'Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.'}, {'measure': 'Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.'}, {'measure': 'Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.', 'timeFrame': 'Baseline and week 4', 'description': 'Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.'}, {'measure': 'Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.', 'timeFrame': 'Baseline and week 8', 'description': 'Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.'}, {'measure': 'Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8', 'timeFrame': 'Baseline and week 4', 'description': 'Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8'}, {'measure': 'Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8', 'timeFrame': 'Baseline and week 8', 'description': 'Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8'}, {'measure': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'week 2', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.'}, {'measure': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'week 4', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.'}, {'measure': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'week 8', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.'}, {'measure': "Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'End of treatment', 'description': 'Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.'}, {'measure': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'timeFrame': 'week 2', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).'}, {'measure': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'timeFrame': 'Baseline and week 4', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).'}, {'measure': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'timeFrame': 'Baseline and week 8', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).'}, {'measure': 'Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.', 'timeFrame': 'Baseline and end of treatment (up to 8 weeks)', 'description': 'Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).'}, {'measure': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'week 2', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe."}, {'measure': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'week 4', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation."}, {'measure': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'week 8', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation."}, {'measure': "Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.", 'timeFrame': 'End of treatment', 'description': "Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scalp Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis. LEO 80185 topical suspension has marketing approval in many countries under the brand names Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent given by parent(s) or legal guardian following their receipt of verbal and written information about the study\n* Subjects will receive verbal and written information and will provide written assent to the study\n* Any race or ethnicity\n* Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs\n* At Screening Visit 2 and Visit 1 a clinical diagnosis of scalp psoriasis which is:\n\n * amenable to topical treatment with a maximum of 60 g of study medication per week, and\n * of an extent of more than or equal to 20% of the scalp area\n * of at least moderate severity according to the investigator's global assessment\n* Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge\n* A serum albumin-corrected calcium below the upper reference limit at Screening Visit 2\n* Females of child-bearing potential must have a negative urine pregnancy test result and must agree to use a highly effective method of contraception (abstinence is an acceptable method).\n\nExclusion Criteria (summary):\n\n* A history of serious allergy, allergic asthma or serious allergic skin rash\n* Known or suspected hypersensitivity to any medication (including ACTH/cosyntropin/tetracosactide) or to any component of the LEO 80185 topical suspension or CORTROSYN\n* Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to Screening Visit 2 or during the study\n* Topical treatment with corticosteroids within 2 weeks prior to Screening Visit 2 or during the study\n* Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to Screening Visit 2 or during the study\n* Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin)or cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to Screening Visit 2 or during the study. Topical ketoconazole 2 weeks prior to Screening Visit 2\n* Hypoglycemic sulfonamides or Antidepressive medications within 4 weeks prior to Screening Visit 2 or during the study\n* Known or suspected endocrine disorder that may affect the results of the ACTH challenge test\n* Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1\n* Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study\n* Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study\n* Other inflammatory skin diseases that may confound the evaluation of scalp psoriasis\n* Known or suspected disorders of calcium metabolism associated with hypercalcaemia"}, 'identificationModule': {'nctId': 'NCT01083758', 'briefTitle': 'Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Effect of Calcipotriol Plus Betamethasone Dipropionate Topical Suspension on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 17 Years) With Scalp Psoriasis', 'orgStudyIdInfo': {'id': 'MBL 0801'}, 'secondaryIdInfos': [{'id': '2008-007606-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LEO 80185 (Taclonex® Scalp topical suspension/ Xamiol® gel)', 'interventionNames': ['Drug: LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)']}], 'interventions': [{'name': 'LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)', 'type': 'DRUG', 'otherNames': ['LEO 80185 topical suspension'], 'description': 'Topical suspension applied once daily for up to 8 weeks', 'armGroupLabels': ['LEO 80185 (Taclonex® Scalp topical suspension/ Xamiol® gel)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Leavitt Medical Associates of Florida, Inc.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Leavitt Medical Associates of Florida, Inc.', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Peachtree Dermatology Associates, PC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Skin Specialists, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Lawrence F Eichenfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Rady Children's Hospital, San Diego"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}