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

NCT ID: NCT04207931

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Central Centrifugal Cicatricial Alopecia (CCCA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Topical steroid class I-II

Intervention Type DRUG

applied once daily - 18 month duration of the study

Doxycyline

Intervention Type DRUG

oral antibiotic twice daily for 6 months

Minoxidil

Intervention Type DRUG

5% solution or foam started after month 8

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

Group Type ACTIVE_COMPARATOR

Topical steroid class I-II

Intervention Type DRUG

applied once daily - 18 month duration of the study

Triamcinolone Acetonide

Intervention Type 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.

Minoxidil

Intervention Type DRUG

5% solution or foam started after month 8

Interventions

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Topical steroid class I-II

applied once daily - 18 month duration of the study

Intervention Type 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.

Intervention Type DRUG

Doxycyline

oral antibiotic twice daily for 6 months

Intervention Type DRUG

Minoxidil

5% solution or foam started after month 8

Intervention Type DRUG

Other Intervention Names

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Clobetasol, Betamethasone Dipropionate, or Fluocinonide Kenaolog Doxy-100 Targadox Oracea Rogaine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Skin of Color Society

UNKNOWN

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy J McMichael, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Health Department of Dermatology

Locations

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Wake Forest Baptist Health Department of Dermatology

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy J McMichael, MD

Role: CONTACT

336.716.3926

Judy Holbrook, CRC

Role: CONTACT

336.716.8991

References

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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.

Reference Type BACKGROUND
PMID: 1739290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22092575 (View on PubMed)

Other Identifiers

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IRB00043796

Identifier Type: -

Identifier Source: org_study_id

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