Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA) ((CCCA))
Primary Purpose
Central Centrifugal Cicatricial Alopecia
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
azelaic acid
usual medication for CCCA
Sponsored by
About this trial
This is an interventional treatment trial for Central Centrifugal Cicatricial Alopecia focused on measuring hair growth, hair follicle regrowth, hair loss regression
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
Sites / Locations
- Wake Forest University Health Scieces
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
azelaic acid treatment
control (no additional treatment)
Arm Description
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
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.
Outcomes
Primary Outcome Measures
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Amount of hair loss regression
measured by standardized photos and dermatoscope photos
Secondary Outcome Measures
Amount of hair regrowth
measured by standardized photos and dermatoscope photos
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.
Dermatology Life Quality Index (DLQI)
Scores of "not at all" to "very much"
Full Information
NCT ID
NCT05416333
First Posted
June 8, 2022
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05416333
Brief Title
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Acronym
(CCCA)
Official Title
A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Centrifugal Cicatricial Alopecia
Keywords
hair growth, hair follicle regrowth, hair loss regression
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
azelaic acid treatment
Arm Type
Experimental
Arm Description
Subjects will use the topical formulation once daily on the scalp. The subjects will use the treatment for a total of 6 months.
Arm Title
control (no additional treatment)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
azelaic acid
Other Intervention Name(s)
Finacea
Intervention Description
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
Other
Intervention Name(s)
usual medication for CCCA
Intervention Description
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
Primary Outcome Measure Information:
Title
Amount of hair loss regression
Description
measured by standardized photos and dermatoscope photos
Time Frame
Baseline
Title
Amount of hair loss regression
Description
measured by standardized photos and dermatoscope photos
Time Frame
Month 2
Title
Amount of hair loss regression
Description
measured by standardized photos and dermatoscope photos
Time Frame
Month 4
Title
Amount of hair loss regression
Description
measured by standardized photos and dermatoscope photos
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Amount of hair regrowth
Description
measured by standardized photos and dermatoscope photos
Time Frame
Months 2, 4, and 6
Title
Amount of alleviation of signs and symptoms of disease
Description
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.
Time Frame
Months 2, 4, and 6
Title
Dermatology Life Quality Index (DLQI)
Description
Scores of "not at all" to "very much"
Time Frame
Baseline and Month 6
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge F Larrondo, MD
Phone
(336)716-3926
Email
jflarron@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J McMichael, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Scieces
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge F Larrondo, MD
Phone
336-716-3926
Email
jflarron@wakehealth.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
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