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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Central Centrifugal Cicatricial Alopecia
• Intervention / Treatment: Drug: azelaic acid; Other: usual medication for CCCA

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ivie Obeime, DO; Phone Number: (336)716-3926; Email: ivie.obeime@gmail.com

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Scieces
      • Contact: Ivie Obeime, DO; Phone Number: 336-716-3926; Email: ivie.obeime@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: Finacea
Sham Comparator: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Amy J McMichael, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: hair growth; hair follicle regrowth; hair loss regression
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: IRB00076717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No