Clinical trial NCT05416333: Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Official title: A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Central Centrifugal Cicatricial Alopecia
Keywords: hair growth
hair follicle regrowth
hair loss regression
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of hair loss regression
timeFrame: Baseline
measure: Amount of hair loss regression
timeFrame: Month 2
measure: Amount of hair loss regression
timeFrame: Month 4
measure: Amount of hair loss regression
timeFrame: Month 6
Secondary outcomes:
measure: Amount of hair regrowth
timeFrame: Months 2, 4, and 6
measure: Amount of alleviation of signs and symptoms of disease
timeFrame: Months 2, 4, and 6
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Scieces
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy J McMichael, MD
role: PRINCIPAL_INVESTIGATOR
References: