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

NCT05416333 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00076717
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

hair growth; hair follicle regrowth; hair loss regression

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Amount of hair regrowth

  Months 2, 4, and 6

• Amount of alleviation of signs and symptoms of disease

  Months 2, 4, and 6

• Dermatology Life Quality Index (DLQI)

  Baseline and Month 6

Study Arms (2)

azelaic acid treatment

EXPERIMENTAL

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

control (no additional treatment)

SHAM COMPARATOR

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

Interventions

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

Also known as: Finacea

azelaic acid treatment

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

control (no additional treatment)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• males

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Scieces

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

azelaic acid

Study Officials

• Amy J McMichael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: August 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)