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NCT Number: NCT05416333

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Central Centrifugal Cicatricial Alopecia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Wake Forest University Health Scieces

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azelaic acid

Drug

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

Other names: Finacea

usual medication for CCCA

Other

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

Primary outcomes

  1. Amount of hair loss regression

    Time frame: Baseline

    measured by standardized photos and dermatoscope photos

  2. Amount of hair loss regression

    Time frame: Month 2

    measured by standardized photos and dermatoscope photos

  3. Amount of hair loss regression

    Time frame: Month 4

    measured by standardized photos and dermatoscope photos

  4. Amount of hair loss regression

    Time frame: Month 6

    measured by standardized photos and dermatoscope photos

Secondary outcomes

  1. Amount of hair regrowth

    Time frame: Months 2, 4, and 6

    measured by standardized photos and dermatoscope photos

  2. Amount of alleviation of signs and symptoms of disease

    Time frame: 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.

  3. Dermatology Life Quality Index (DLQI)

    Time frame: Baseline and Month 6

    Scores of "not at all" to "very much"

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia

Acronym: (CCCA)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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