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

Central Centrifugal Cicatricial Alopecia Clinical Trial

— (CCCA)  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05416333
• Other study ID #: IRB00076717
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Ivie Obeime, DO
• Phone: (336)716-3926
• Email: iobeime[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Central Centrifugal Cicatricial Alopecia

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	Wake Forest University Health Scieces	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of hair loss regression	measured by standardized photos and dermatoscope photos	Baseline
Primary	Amount of hair loss regression	measured by standardized photos and dermatoscope photos	Month 2
Primary	Amount of hair loss regression	measured by standardized photos and dermatoscope photos	Month 4
Primary	Amount of hair loss regression	measured by standardized photos and dermatoscope photos	Month 6
Secondary	Amount of hair regrowth	measured by standardized photos and dermatoscope photos	Months 2, 4, and 6
Secondary	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
Secondary	Dermatology Life Quality Index (DLQI)	Scores of "not at all" to "very much"	Baseline and Month 6