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

Purpose

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

Condition

Central Centrifugal Cicatricial Alopecia (CCCA)

Eligibility

Eligible Ages: Between 18 Years and 60 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

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

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)
Masking Description: 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.

Arm Groups

Arm	Description	Assigned Intervention
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.	Drug: Topical steroid class I-II applied once daily - 18 month duration of the study Other names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide 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
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	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: Minoxidil 5% solution or foam started after month 8 Other names: Rogaine

Recruiting Locations

Wake Forest Baptist Health Department of Dermatology
Winston-Salem, North Carolina 27157

More Details

NCT ID: NCT04207931
Status: Recruiting
Sponsor: Wake Forest University Health Sciences

Study Contact

Amy J McMichael, MD
336.716.3926
amcmichael@wakehealth.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.