Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04207931

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest Baptist Health Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical steroid class I-II

Drug

applied once daily - 18 month duration of the study

Other names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide

Triamcinolone Acetonide

Drug

Intralesional Steroid Injection, 7.5mg/cc. max dose of 3 cc. Scalp injections will be administered every 6-8 weeks, for a total of 8 injections.

Other names: Kenaolog

Doxycyline

Drug

oral antibiotic twice daily for 6 months

Other names: Doxy-100, Targadox, Oracea

minoxidil

Drug

5% solution or foam started after month 8

Other names: Rogaine

Primary outcomes

  1. Central Scalp Alopecia Photographic Scale in African American Women

    Time frame: baseline

    Photographs of the subject's scalp will be taken at baseline. 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.

  2. Central Scalp Alopecia Photographic Scale in African American Women

    Time frame: 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 outcomes

  1. Hair Loss Questionnaire

    Time frame: 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.

  2. Dermatology Life Quality Index (DLQI)

    Time frame: 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.

  3. Last Year Dermatology Life Quality Index (LYDLQI)

    Time frame: 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.

  4. Central Scalp Alopecia Photographic Scale in African American Women

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy J McMichael, MD

CONTACT

[email protected]

336.716.3926

Judy Holbrook, CRC

CONTACT

[email protected]

336.716.8991

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • The Skin of Color Society

Registry information

Acronym: CCCA

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Dec 23, 2019
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.