Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02749656
Status:
UNKNOWN
Last Update Posted:
2017-05-01
First Post:
2016-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003899', 'term': 'Desoximetasone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of Investigator's Global Assessment score (IGA) after treatment", 'timeFrame': '2, 4 and 8 weeks', 'description': "The Investigator's Global Assessment score (IGA) was recorded at the first visit and after treated 2,4 and 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. The IGA score consisted of 6 points score (0 = absent disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease)"}], 'secondaryOutcomes': [{'measure': 'Change of total sign score (TSS) after treatment', 'timeFrame': '2, 4 and 8 weeks', 'description': 'The Total sign score (TSS) was recorded at the first visit and after treated 2,4 and 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo. The TSS score was the sum of 5-point rating scores for erythema, induration and scaling (0 = no sign, 1 = slight signs, 2 = moderate signs, 3 = severe signs and 4 = very severe signs)'}, {'measure': 'Number of patients with clear or absent disease after treatment', 'timeFrame': '8 weeks', 'description': 'Number of patients with clear or absent disease were recorded after treated 8 weeks with 0.25% Desoximetasone cream (Topoxy®), 0.25% Desoximetasone cream (Topicorte®) or placebo.'}, {'measure': 'Side effects after treatment', 'timeFrame': '2, 4 and 8 weeks', 'description': 'Cutaneous side effects (e.g. skin discomfort, skin atrophy, telangiectasia) from 0.25% Desoximetasone cream were recorded after treated 2, 4 and 8 weeks.\n\nThe side effects were scored as 0 = none, 1 = mild, 2 = moderate, 3 = severe for skin discomfort, skin atrophy and telangiectasia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Scalp psoriasis', '0.25% Desoximetasone cream'], 'conditions': ['Scalp Psoriasis']}, 'referencesModule': {'references': [{'pmid': '24301242', 'type': 'BACKGROUND', 'citation': 'Kircik L, Lebwohl MG, Del Rosso JQ, Bagel J, Stein Gold L, Weiss JS. Clinical study results of desoximetasone spray, 0.25% in moderate to severe plaque psoriasis. J Drugs Dermatol. 2013 Dec;12(12):1404-10.'}, {'pmid': '800971', 'type': 'BACKGROUND', 'citation': 'Kuokkanen K. Comparison of 0.25% desoxymethasone ointment with 0.05% fluocinonide ointment in psoriasis. Curr Med Res Opin. 1976-1977;4(10):703-5. doi: 10.1185/03007997609112005.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of 0.25% Desoximetasone cream (Topoxy®) compare with 0.25% Desoximetasone cream (Topicorte®) in the treatment of scalp psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Diagnosed with scalp psoriasis by dermatologist\n3. Has scalp psoriasis Involve ≥ 10% of total scalp area and also has clinical signs, or a previous diagnosis, of psoriasis on the trunk and/or limbs\n4. Total severity of scalp psoriasis should be graded in mild to very severe according to Investigator\'s Global Assessment score (IGA)\n5. Clinical signs (redness, thickness, scaliness) should be scored as "Moderate" for at least 1 sign and "slight" on each of the other two signs\n6. All participants agree to participate in the study and already complete and sign consent form\n\nExclusion Criteria:\n\n1. Treated with these medications before including in the study\n\n * Topical corticosteroid for scalp psoriasis (except emollients and shampoo) within 2 weeks\n * Very potent topical corticosteroids for psoriasis on other area or Narrow band Ultraviolet B (NB-UVB) within 2 weeks\n * Oral psoralen plus Ultraviolet A (PUVA) or oral medication (Methotrexate, Acitretin, Cyclosporine) within 4 weeks\n * Biologic agents or concomitant medication that could affect scalp psoriasis (Beta- blockers, Antimalarial drugs, Lithium ) within 6 months\n2. Has skin infection or atrophic skin on the scalp\n3. Has history of allergic reaction or hypersensitivity to 0.25% Desoximetasone\n4. Female participants with pregnancy or in lactation period\n5. Participants who unable to come for follow-up visits at hospital\n6. Participants with other underlying disease e.g. diabetes mellitus, hypertension, thyroid disease\n7. Vulnerable subject e.g. illiterate person'}, 'identificationModule': {'nctId': 'NCT02749656', 'briefTitle': 'Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'A Randomized Control Trial of Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) Compared With 0.25% Desoximetasone Cream (Topicorte®) in the Treatment of Scalp Psoriasis', 'orgStudyIdInfo': {'id': 'SPS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.25% Desoximetasone cream (Topoxy®)', 'description': '0.25% Desoximetasone cream (Topoxy®): apply on scalp psoriasis lesion twice a day for 8 weeks.\n\n(Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.)', 'interventionNames': ['Drug: 0.25% Desoximetasone cream (Topoxy®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.25% Desoximetasone cream (Topicorte®)', 'description': '0.25% Desoximetasone cream (Topicorte®): apply on scalp psoriasis lesion twice a day for 8 weeks.\n\n(Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.)', 'interventionNames': ['Drug: 0.25% Desoximetasone cream (Topicorte®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: apply on scalp psoriasis lesion twice a day for 8 weeks. (Tar shampoo will be given to all participants. The Shampoo should be applied on wet scalp every other day, then massage and allow shampoo to remain on the scalp for 5 minutes, after that rinse off by water.)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '0.25% Desoximetasone cream (Topoxy®)', 'type': 'DRUG', 'otherNames': ['Topoxy®'], 'description': 'apply on the scalp psoriasis lesion twice a day', 'armGroupLabels': ['0.25% Desoximetasone cream (Topoxy®)']}, {'name': '0.25% Desoximetasone cream (Topicorte®)', 'type': 'DRUG', 'otherNames': ['Topicorte®'], 'description': 'apply on the scalp psoriasis lesion twice a day', 'armGroupLabels': ['0.25% Desoximetasone cream (Topicorte®)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['vehicle'], 'description': 'apply on the scalp psoriasis lesion twice a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10900', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Pichanee Chaweekulrat, MD', 'role': 'CONTACT', 'email': 'pizzu43087@gmail.com', 'phone': '66868865277'}, {'name': 'Chanisada Wongpraparut, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leena Chularojmontri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Narumol Silpa-archa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pichanee Chaweekulrat, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of dermatology Faculty of Medicine Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Pichanee Chaweekulrat, M.D.', 'role': 'CONTACT', 'email': 'pizzu43087@gmail.com', 'phone': '+6686-886-5277'}], 'overallOfficials': [{'name': 'Associated. Prof. Chanisada Wongpraparut, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}, {'name': 'Assist. Prof. Leena Chularojmontri, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}, {'name': 'Assist. Prof. Narumol Silpa-archa, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}, {'name': 'Pichanee Chaweekulrat, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SPS MEDICAL CO.,LTD.', 'class': 'UNKNOWN'}, {'name': 'Siriraj clinical research center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Pichanee Chaweekulrat', 'investigatorAffiliation': 'Siriraj Hospital'}}}}