Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)

Early Phase 1

Withdrawn

• Conditions: Central Centrifugal Cicatricial Alopecia
• Interventions: Drug: Calcipotriol; Drug: Subject's already prescribed drug

• Registration Number: NCT05416320
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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)"

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Status Verified: 2023-08
• Study Start: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-31
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women who are eighteen years of age or older
• biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV
• must be on stable treatment without changes for at least 3 months
• Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.

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Exclusion Criteria

• Males

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcipotriol Group	Calcipotriol	Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
Control Group	Subject's already prescribed drug	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.

Primary Outcome Measures

Name	Time	Method
Amount of hairline stabilization	Month 6	Standardized camera and dermatoscopic photographs

Secondary Outcome Measures

Name	Time	Method
Signs and symptoms of disease score	Month 2, Month 4, and Month 6	standardized questionnaire - higher scores denotes worse condition
Dermatology Life Quality Index score	Baseline and Month 6	scores of "not at all" to "very much"
Amount of hair regrowth	Baseline, Month 2, Month 4, and Month 6	Standardized camera and dermatoscopic photographs

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States