Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study

Phase 4

Recruiting

• Conditions: Central Centrifugal Cicatricial Alopecia (CCCA)
• Interventions: Drug: Topical steroid class I-II; Drug: Doxycyline; Drug: Triamcinolone Acetonide; Drug: Minoxidil

• Registration Number: NCT04207931
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups

Detailed Description

Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months. Both these regimens are used as the first-line treatments by clinicians. The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups.

In this study, the investigators are looking to determine how standard treatment affects the outcome of central centrifugal cicatricial alopecia; to determine if topical steroid with With Doxycycline has better outcome than topical steroids with intralesional steroids in central centrifugal cicatricial alopecia, and to determine how the addition of topical minoxidil as a treatment changes the outcome of central centrifugal cicatricial alopecia.

Study Timeline

• Study Start: 2018-04-30
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• African-American women, ages 18-60 years old
• with a clinical diagnosis and biopsy-proven CCCA, with Central Scalp Alopecia Scale severity 1 through 4 will be included in this study
• These subjects will be seen and treated in Wake Forest Baptist Health Dermatology Outpatient Clinic

Exclusion Criteria

• Patients with other forms of hair loss in addition to CCCA will be excluded
• Other patients to be excluded are those with other forms of inflammatory scalp disease (with the exception of mild seborrheic dermatitis)
• patients who have had topical treatment for CCCA within the past 4 months (including topical steroids, topical minoxidil, or any other topical hair regrowth medication)
• patients who have been on a long-term oral antibiotics for hair loss within the past year
• patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical steroid plus oral antibiotic group	Topical steroid class I-II	Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment.
Topical steroid plus oral antibiotic group	Doxycyline	Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment.
Topical steroid plus intralesional steroid injection group	Topical steroid class I-II	Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment
Topical steroid plus intralesional steroid injection group	Triamcinolone Acetonide	Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment
Topical steroid plus oral antibiotic group	Minoxidil	Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment.
Topical steroid plus intralesional steroid injection group	Minoxidil	Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment

Primary Outcome Measures

Name	Time	Method
Central Scalp Alopecia Photographic Scale in African American Women	Visit 4, Month 6	This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.

Secondary Outcome Measures

Name	Time	Method
Hair Loss Questionnaire	Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20	Questionnaire gathers the epidemiologic data about the patient's hair loss, family history of hair loss, what treatments have been tried in the past, and hair care practices.; There is no range and/or direction as this questionnaire is used to gather descriptive data.
Dermatology Life Quality Index (DLQI)	Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20	Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past week. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Last Year Dermatology Life Quality Index (LYDLQI)	Baseline	Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past year. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Central Scalp Alopecia Photographic Scale in African American Women	Visit 7, Month 12; Visit 9, Month 18-20	This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.

Trial Locations

Locations (1)

Wake Forest Baptist Health Department of Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States