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

Early Phase 1

Not yet recruiting

• Conditions: Central Centrifugal Cicatricial Alopecia
• Interventions: Other: usual medication for CCCA; Drug: azelaic acid

• Registration Number: NCT05416333
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-12
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control (no additional treatment)	usual medication for CCCA	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.
azelaic acid treatment	azelaic acid	Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.

Primary Outcome Measures

Name	Time	Method
Amount of hair loss regression	Month 6	measured by standardized photos and dermatoscope photos

Secondary Outcome Measures

Name	Time	Method
Amount of alleviation of signs and symptoms of disease	Months 2, 4, and 6	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.
Amount of hair regrowth	Months 2, 4, and 6	measured by standardized photos and dermatoscope photos
Dermatology Life Quality Index (DLQI)	Baseline and Month 6	Scores of "not at all" to "very much"

Trial Locations

Locations (1)

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