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Recruiting NCT04207931

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

Phase IV Interventional Central Centrifugal Cicatricial Alopecia (CCCA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topical steroid class I-II, Triamcinolone Acetonide, Doxycyline, Minoxidil.
Who it may be relevant to
Registry conditions: Central Centrifugal Cicatricial Alopecia (CCCA). Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Topical steroid class I-II
    applied once daily - 18 month duration of the study
  • 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.
  • Drug Doxycyline
    oral antibiotic twice daily for 6 months
  • Drug Minoxidil
    5% solution or foam started after month 8

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Hair Loss Questionnaire [Time frame: Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20]
  • Dermatology Life Quality Index (DLQI) [Time frame: Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20]
  • Last Year Dermatology Life Quality Index (LYDLQI) [Time frame: Baseline]
  • Central Scalp Alopecia Photographic Scale in African American Women [Time frame: Visit 7, Month 12; Visit 9, Month 18-20]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest Baptist Health Department of Dermatology — Winston-Salem

Publications

  • Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74. PMID 1739290
  • Bin Saif GA, Ericson ME, Yosipovitch G. The itchy scalp--scratching for an explanation. Exp Dermatol. 2011 Dec;20(12):959-68. doi: 10.1111/j.1600-0625.2011.01389.x. PMID 22092575

Identifiers

NCT: NCT04207931 · IRB00043796

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗