Official Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    250
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
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 Started
Apr 30
2018
Primary Completion
Jan 31
2024
Anticipated
Study Completion
Jul 31
2024
Anticipated
Last Update
Nov 01
2023

Drug Topical steroid class I-II

applied once daily - 18 month duration of the study

  • Other names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide

Drug 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.

  • Other names: Kenaolog

Drug Doxycyline

oral antibiotic twice daily for 6 months

  • Other names: Doxy-100, Targadox, Oracea

Drug Minoxidil

5% solution or foam started after month 8

  • Other names: Rogaine

Topical steroid plus oral antibiotic group Active Comparator

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 Active Comparator

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

Criteria

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.
No Results Posted