Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04207931

Conditions

Central Centrifugal Cicatricial Alopecia (CCCA)

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Topical steroid class I-II

Triamcinolone Acetonide

Doxycyline

Minoxidil

Study Details

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

Conditions

Central Centrifugal Cicatricial Alopecia (CCCA)

Study ID

NCT04207931

Start date

Apr 30, 2018

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Topical steroid plus oral antibiotic group

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.

active comparator: Topical steroid plus intralesional steroid injection group

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

Interventions

Topical steroid class I-II

applied once daily - 18 month duration of the study

Triamcinolone Acetonide

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.

Doxycyline

oral antibiotic twice daily for 6 months

Minoxidil

5% solution or foam started after month 8

Primary outcome measure

  • Central Scalp Alopecia Photographic Scale in African American Women [ Time Frame: baseline ]
  • Central Scalp Alopecia Photographic Scale in African American Women [ Time Frame: Visit 4, Month 6 ]

Central Contacts and Locations

Central contacts

Amy J McMichael, MD

336.716.3926amcmichael@wakehealth.edu

Judy Holbrook, CRC

336.716.8991jholbroo@wakehealth.edu

Locations

Wake Forest Baptist Health Department of Dermatology

Recruiting

Winston-Salem, North Carolina, United States, 27157

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • alopecia
  • Hair loss
  • Female hair loss
  • Minoxidil
  • Topical Steroid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-31.