Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-26 @ 2:28 AM
Study NCT ID:
NCT00419666
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2007-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Studies@galderma.com', 'phone': '817 961 5000', 'title': 'Clinical Operations', 'phoneExt': '+1', 'organization': 'Galderma'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of the study to Day 56', 'eventGroups': [{'id': 'EG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 8, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Plasma Levels (Ctrough) of Calcitriol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '65.04', 'spread': '18.851', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '62.53', 'spread': '17.742', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '61.87', 'spread': '17.703', 'groupId': 'OG000'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '61.46', 'spread': '22.811', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (Baseline), Day 14, Day 21, and Day 56', 'description': 'Trough plasma levels (Ctrough) of calcitriol was reported.', 'unitOfMeasure': 'Picograms Per Millilitre (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'PRIMARY', 'title': 'The Observed Peak Drug Concentration (Cmax) of Calcitriol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '75.74', 'spread': '24.337', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '73.18', 'spread': '21.514', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (Baseline), Day 21', 'description': 'Cmax of calcitriol was reported.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '575.12', 'spread': '181.761', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '549.29', 'spread': '155.277', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21', 'description': 'The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.', 'unitOfMeasure': 'Picograms. hours per millilitre(pg.h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '764.74', 'spread': '230.003', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '737.74', 'spread': '203.740', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21', 'description': 'The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.', 'unitOfMeasure': 'pg.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'PRIMARY', 'title': 'Time at Which Maximum Concentration (Cmax) Occurred (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'title': 'Day 0 (Baseline)', 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.0'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '3.97', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 (Baseline), Day 21', 'description': 'Tmax is the time to reach maximum concentration and was reported for calcitriol.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'title': 'Serum Calcium', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.254', 'groupId': 'OG000'}]}]}, {'title': 'Urinary (U) Calcium Random', 'categories': [{'measurements': [{'value': '1.00', 'spread': '6.767', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.641', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (Day 0) up to Day 56', 'description': 'Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.', 'unitOfMeasure': 'milligrams per deciliter (Mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.083', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (Day 0) up to Day 56', 'description': 'Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.', 'unitOfMeasure': 'Millimoles Per Litre (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.076', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (Day 0) up to Day 56', 'description': 'Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of the study to Day 56', 'description': 'An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants in the ITT population who had applied the study medication at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in 7 sites (5 in United States and 2 in Canada) between 01 Aug 2006 (first participant enrolled) to 24 Sep 2009 (last participant completed).', 'preAssignmentDetails': 'A total of 25 participants were enrolled and completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcitriol 3mcg/g', 'description': 'Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '25', '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': '14.7', 'spread': '1.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population consisted of all participants who were enrolled and to whom medication was dispensed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2009-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2007-01-05', 'resultsFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-21', 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Plasma Levels (Ctrough) of Calcitriol', 'timeFrame': 'Day 0 (Baseline), Day 14, Day 21, and Day 56', 'description': 'Trough plasma levels (Ctrough) of calcitriol was reported.'}, {'measure': 'The Observed Peak Drug Concentration (Cmax) of Calcitriol', 'timeFrame': 'Day 0 (Baseline), Day 21', 'description': 'Cmax of calcitriol was reported.'}, {'measure': 'Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])', 'timeFrame': '0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21', 'description': 'The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.'}, {'measure': 'Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])', 'timeFrame': '0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21', 'description': 'The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.'}, {'measure': 'Time at Which Maximum Concentration (Cmax) Occurred (Tmax)', 'timeFrame': 'Day 0 (Baseline), Day 21', 'description': 'Tmax is the time to reach maximum concentration and was reported for calcitriol.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56', 'timeFrame': 'From baseline (Day 0) up to Day 56', 'description': 'Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.'}, {'measure': 'Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56', 'timeFrame': 'From baseline (Day 0) up to Day 56', 'description': 'Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.'}, {'measure': 'Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56', 'timeFrame': 'From baseline (Day 0) up to Day 56', 'description': 'Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From start of the study to Day 56', 'description': 'An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.'}]}, 'conditionsModule': {'keywords': ['Calcitriol', 'Psoriasis', 'PK', 'Adolescents'], 'conditions': ['Chronic Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic plaque psoriasis\n* 10 - 35% BSA of involved skin\n* Age 12 - 17\n\nExclusion Criteria:\n\n* Other type of psoriasis (other than plaque)\n* Significant abnormal lab findings\n* Vit D insufficiency'}, 'identificationModule': {'nctId': 'NCT00419666', 'briefTitle': 'A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'RD.06.SPR.18102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcitriol 3mcg/g', 'description': 'Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.', 'interventionNames': ['Drug: Calcitriol 3mcg/g']}], 'interventions': [{'name': 'Calcitriol 3mcg/g', 'type': 'DRUG', 'otherNames': ['CD2027', 'Vectical'], 'description': 'Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.', 'armGroupLabels': ['Calcitriol 3mcg/g']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Dermatology Research of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital, Department of Pediatric and Adolescent Dermatology", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '55121', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Dermatology Center For Children & Young Adults', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas-Houston Medical Center Dept of Dermatology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': 'A1B 3E1', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Nexus Clinical Research', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'A1C 2H5', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Newlab Clinical Research, Inc.', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}], 'overallOfficials': [{'name': 'Michael Graeber, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}