Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT05416320
Status:
WITHDRAWN
Last Update Posted:
2023-08-31
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "10 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with calcipotriol, or the control (no additional treatment besides Subject's already prescribed drug)"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The IRB was closed without enrolling any participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of hairline stabilization', 'timeFrame': 'Baseline', 'description': 'Standardized camera and dermatoscopic photographs'}, {'measure': 'Amount of hairline stabilization', 'timeFrame': 'Month 2', 'description': 'Standardized camera and dermatoscopic photographs'}, {'measure': 'Amount of hairline stabilization', 'timeFrame': 'Month 4', 'description': 'Standardized camera and dermatoscopic photographs'}, {'measure': 'Amount of hairline stabilization', 'timeFrame': 'Month 6', 'description': 'Standardized camera and dermatoscopic photographs'}], 'secondaryOutcomes': [{'measure': 'Amount of hair regrowth', 'timeFrame': 'Baseline, Month 2, Month 4, and Month 6', 'description': 'Standardized camera and dermatoscopic photographs'}, {'measure': 'Signs and symptoms of disease score', 'timeFrame': 'Month 2, Month 4, and Month 6', 'description': 'standardized questionnaire - higher scores denotes worse condition'}, {'measure': 'Dermatology Life Quality Index score', 'timeFrame': 'Baseline and Month 6', 'description': 'scores of "not at all" to "very much"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hair loss', 'hair follicle regrowth'], 'conditions': ['Central Centrifugal Cicatricial Alopecia']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). This study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.', 'detailedDescription': 'Calcipotriol, a vitamin D analog, has been topically used to treat alopecia areata, a form of non-scarring autoimmune alopecia in several studies. It is possible that Vitamin D plays a role in sustaining the hair follicle\'s immune privilege through anti-inflammatory effects such as controlling Interferon gamma (IFN-γ) production. A recent study showed a significant decrease of vitamin D in Black patients with Central Centrifugal Cicatricial Alopecia (CCCA)"'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are eighteen years of age or older\n* biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV\n* must be on stable treatment without changes for at least 3 months\n* Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.\n\nExclusion Criteria:\n\n* Males'}, 'identificationModule': {'nctId': 'NCT05416320', 'acronym': 'CCCA', 'briefTitle': 'Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia', 'orgStudyIdInfo': {'id': 'IRB00076702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcipotriol Group', 'description': 'Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.', 'interventionNames': ['Drug: Calcipotriol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Subjects will continue to use their primary physician prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.', 'interventionNames': ["Drug: Subject's already prescribed drug"]}], 'interventions': [{'name': 'Calcipotriol', 'type': 'DRUG', 'otherNames': ['Dovonex'], 'description': 'Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.', 'armGroupLabels': ['Calcipotriol Group']}, {'name': "Subject's already prescribed drug", 'type': 'DRUG', 'description': 'Subjects will continue to use their already prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Amy McMichael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}