Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-04-17 @ 12:29 PM
Study NCT ID:
NCT05416333
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C010038', 'term': 'azelaic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "15 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with azelaic acid or the control (no additional treatment besides Subject's already prescribed drug)"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of hair loss regression', 'timeFrame': 'Baseline', 'description': 'measured by standardized photos and dermatoscope photos'}, {'measure': 'Amount of hair loss regression', 'timeFrame': 'Month 2', 'description': 'measured by standardized photos and dermatoscope photos'}, {'measure': 'Amount of hair loss regression', 'timeFrame': 'Month 4', 'description': 'measured by standardized photos and dermatoscope photos'}, {'measure': 'Amount of hair loss regression', 'timeFrame': 'Month 6', 'description': 'measured by standardized photos and dermatoscope photos'}], 'secondaryOutcomes': [{'measure': 'Amount of hair regrowth', 'timeFrame': 'Months 2, 4, and 6', 'description': 'measured by standardized photos and dermatoscope photos'}, {'measure': 'Amount of alleviation of signs and symptoms of disease', 'timeFrame': 'Months 2, 4, and 6', 'description': 'Higher scores means worse symptoms and signs of disease - Clinical signs and symptoms of CCCA will be documented by administering a standardized questionnaire to all subjects. Subjects will complete the standardized questionnaire regarding symptoms of their hair loss at the start of the enrollment and every 2 months until the study is completed.'}, {'measure': 'Dermatology Life Quality Index (DLQI)', '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 growth', 'hair follicle regrowth', 'hair loss regression'], 'conditions': ['Central Centrifugal Cicatricial Alopecia']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.', 'detailedDescription': 'The management of Central Centrifugal Cicatricial Alopecia (CCCA) is challenging due to limited current treatments and a lack of randomized controlled trials. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged. Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos. These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density. Currently, comparison studies of different treatments for CCCA subjects is limited. The aim is to determine if there is an advantage in using one particular anti-inflammatory therapy over another for relieving symptoms and promoting hair follicle regrowth.'}, '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 eighteen years of age or older\n* biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV\n* on stable treatment without changes for at least three months\n* recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology\n\nExclusion Criteria:\n\n* males'}, 'identificationModule': {'nctId': 'NCT05416333', 'acronym': '(CCCA)', 'briefTitle': 'Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia', 'orgStudyIdInfo': {'id': 'IRB00076717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'azelaic acid treatment', '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: azelaic acid']}, {'type': 'SHAM_COMPARATOR', 'label': 'control (no additional treatment)', 'description': 'Subjects will continue to use their current primary provider prescribed topical formulation once daily on the scalp. The subjects will use their treatment for a total of 6 months.', 'interventionNames': ['Other: usual medication for CCCA']}], 'interventions': [{'name': 'azelaic acid', 'type': 'DRUG', 'otherNames': ['Finacea'], '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': ['azelaic acid treatment']}, {'name': 'usual medication for CCCA', 'type': 'OTHER', '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 (no additional treatment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria Palmer, MD, MSc', 'role': 'CONTACT', 'email': 'vpalmer@wakehealth.edu', 'phone': '336-716-3926'}], 'facility': 'Wake Forest University Health Scieces', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Victoria Palmer, MD, MSc', 'role': 'CONTACT', 'email': 'vpalmer@wakehealth.edu', 'phone': '(336)716-3926'}], 'overallOfficials': [{'name': 'Amy J 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'}}}}