Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05885269
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.', 'timeFrame': '6 months', 'description': 'The degree of response was assessed on the basis of hair regrowth as excellent (\\>75% regrowth), marked (51-75% regrowth), moderate (26-50% regrowth), or slight (≤25% regrowth)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (\\>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value \\<0.05 as significant, was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 20 to 50 years\n* Both male and female\n* Duration of illness less than 2 months\n* those who never received any treatment before\n\nExclusion Criteria:\n\n* Patients having duration of alopecia greater than 2 months\n* Atypical alopecia areata i.e., Alopecia universalis etc\n* Hypersensitivity history to topical corticosteroids or tacrolimus\n* patients taking any systemic immune suppression\n* pregnancy/lactation'}, 'identificationModule': {'nctId': 'NCT05885269', 'briefTitle': 'Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital Abbottabad'}, 'officialTitle': 'Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata', 'orgStudyIdInfo': {'id': 'CMHAbbottabad2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A applied Clobetasol Propionate 0.05%', 'description': 'Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months.', 'interventionNames': ['Drug: Group A applied topical Clobetasol Propionate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B applied topical Tacrolimus 0.1%', 'description': 'Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.', 'interventionNames': ['Drug: Group B applied topical Tacrolimus']}], 'interventions': [{'name': 'Group A applied topical Clobetasol Propionate', 'type': 'DRUG', 'description': 'Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months', 'armGroupLabels': ['Group A applied Clobetasol Propionate 0.05%']}, {'name': 'Group B applied topical Tacrolimus', 'type': 'DRUG', 'description': 'Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.', 'armGroupLabels': ['Group B applied topical Tacrolimus 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abbottabad', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Danyal Sajjad', 'geoPoint': {'lat': 34.1463, 'lon': 73.21168}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital Abbottabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'danyal sajjad', 'investigatorAffiliation': 'Combined Military Hospital Abbottabad'}}}}