Azelaic Acid 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 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.

Detailed Description
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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.

Official Title
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A Pilot Study of Azelaic Acid 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: azelaic acid
* Other: usual medication for CCCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women eighteen years of age or older biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV on stable treatment without changes for at least three months 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: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: azelaic acid treatment<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: azelaic acid<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: Finacea;|
| Sham Comparator: control (no additional treatment)<br>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. | Other: usual medication for CCCA<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 hair loss regression | measured by standardized photos and dermatoscope photos | Baseline | 
| Amount of hair loss regression | measured by standardized photos and dermatoscope photos | Month 2 | 
| Amount of hair loss regression | measured by standardized photos and dermatoscope photos | Month 4 | 
| Amount of hair loss regression | measured by standardized photos and dermatoscope photos | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of hair regrowth | measured by standardized photos and dermatoscope photos | Months 2, 4, and 6 | 
| Amount of alleviation of signs and symptoms of disease | 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. | Months 2, 4, and 6 | 
| Dermatology Life Quality Index (DLQI) | 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 growth, hair follicle regrowth, hair loss regression