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

NCT04207931 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00043796
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Central Scalp Alopecia Photographic Scale in African American Women

  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.

  baseline

• Central Scalp Alopecia Photographic Scale in African American Women

  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.

  Visit 4, Month 6

Secondary Outcomes (4)

• Hair Loss Questionnaire

  Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20

• Dermatology Life Quality Index (DLQI)

  Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20

• Last Year Dermatology Life Quality Index (LYDLQI)

  Baseline

• Central Scalp Alopecia Photographic Scale in African American Women

  Visit 7, Month 12; Visit 9, Month 18-20

Study Arms (2)

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.

Drug: Topical steroid class I-II; Drug: Doxycyline; Drug: Minoxidil

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

Drug: Topical steroid class I-II; Drug: Triamcinolone Acetonide; Drug: Minoxidil

Interventions

Topical steroid class I-II DRUG

applied once daily - 18 month duration of the study

Also known as: Clobetasol, Betamethasone Dipropionate, or Fluocinonide

Topical steroid plus intralesional steroid injection group; Topical steroid plus oral antibiotic group

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.

Also known as: Kenaolog

Topical steroid plus intralesional steroid injection group

Doxycyline DRUG

oral antibiotic twice daily for 6 months

Also known as: Doxy-100, Targadox, Oracea

Topical steroid plus oral antibiotic group

Minoxidil DRUG

5% solution or foam started after month 8

Also known as: Rogaine

Topical steroid plus intralesional steroid injection group; Topical steroid plus oral antibiotic group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: African-American women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Skin of Color Society: collaborator

Study Sites (1)

Wake Forest Baptist Health Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Clobetasol; betamethasone-17,21-dipropionate; Fluocinonide; Triamcinolone Acetonide; Doxycycline; Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fluocinolone Acetonide; Pregnadienes; Pregnanes; Triamcinolone; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Amy J McMichael, MD

  Wake Forest Baptist Health Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy J McMichael, MD

CONTACT

336.716.3926; amcmichael@wakehealth.edu

Judy Holbrook, CRC

CONTACT

336.716.8991; jholbroo@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To help ensure subject privacy and confidentiality, only a unique study identifier will appear on the data collection form. The data collected will be stored on the Research Electronic Database CaptureTM with access limited to designated study personnel. Blinded investigators from Wake Forest Baptist Department of Dermatology will later review photographs of each subject taken at baseline and at month 18 and will assign severity scores to the photographs based on the Central Scalp Alopecia Scale. These investigators will not know when each photograph was taken.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: April 30, 2018
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)