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

NCT ID: NCT05416333

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2026-12-31

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.

Conditions

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Central Centrifugal Cicatricial Alopecia

Keywords

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hair growth hair follicle regrowth hair loss regression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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azelaic acid treatment

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

Group Type EXPERIMENTAL

azelaic acid

Intervention Type DRUG

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

control (no additional treatment)

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.

Group Type SHAM_COMPARATOR

usual medication for CCCA

Intervention Type 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

Interventions

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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

Intervention Type DRUG

usual medication for CCCA

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

Intervention Type OTHER

Other Intervention Names

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Finacea

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy J McMichael, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Scieces

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria Palmer, MD, MSc

Role: CONTACT

Phone: (336)716-3926

Email: [email protected]

Facility Contacts

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Victoria Palmer, MD, MSc

Role: primary

Other Identifiers

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IRB00076717

Identifier Type: -

Identifier Source: org_study_id