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

Study Overview
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Brief Summary
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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
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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)

Official Title
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A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia

Conditions
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Central Centrifugal Cicatricial Alopecia

Intervention / Treatment
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* Drug: Calcipotriol
* Drug: Subject's already prescribed drug


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Males

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcipotriol Group<br>Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months. | Drug: Calcipotriol<br>* Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.<br>* Other names: Dovonex;|
| Sham Comparator: Control Group<br>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. | Drug: Subject's already prescribed drug<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of hairline stabilization | Standardized camera and dermatoscopic photographs | Baseline | 
| Amount of hairline stabilization | Standardized camera and dermatoscopic photographs | Month 2 | 
| Amount of hairline stabilization | Standardized camera and dermatoscopic photographs | Month 4 | 
| Amount of hairline stabilization | Standardized camera and dermatoscopic photographs | Month 6 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hair loss, hair follicle regrowth