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

Phase 4RecruitingNCT04207931

Wake Forest University Health Sciences250 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

250

Conditions

Central Centrifugal Cicatricial Alopecia (CCCA)

Interventions

Topical steroid class I-IIDRUG

applied once daily - 18 month duration of the study

Triamcinolone AcetonideDRUG

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.

DoxycylineDRUG

oral antibiotic twice daily for 6 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wake Forest Baptist Health Department of Dermatology

Winston-Salem, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Visit 4, Month 6

Secondary Outcomes

Hair Loss Questionnaire

Questionnaire gathers the epidemiologic data about the patient's hair loss, family history of hair loss, what treatments have been tried in the past, and hair care practices. There is no range and/or direction as this questionnaire is used to gather descriptive data.

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

Dermatology Life Quality Index (DLQI)

Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past week. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.

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

Last Year Dermatology Life Quality Index (LYDLQI)

Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past year. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.

Central Contacts

Amy J McMichael, MD

CONTACT

336.716.3926 amcmichael@wakehealth.edu

Judy Holbrook, CRC

CONTACT

336.716.8991 jholbroo@wakehealth.edu

Data from ClinicalTrials.gov

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