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

Wake Forest University (WFU)

Status and phase: Enrolling; Early Phase 1

Conditions: Central Centrifugal Cicatricial Alopecia

Treatments: Drug: azelaic acid; Other: usual medication for CCCA

Study type: Interventional

Funder types: Other

Identifiers

NCT05416333

IRB00076717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

azelaic acid treatment

Experimental group

Description:

Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.

Treatment:

Drug: azelaic acid

control (no additional treatment)

Sham Comparator group

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.

Treatment:

Other: usual medication for CCCA