Clinical trial NCT04207931: Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
Official title: Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Central Centrifugal Cicatricial Alopecia (CCCA)
Keywords: alopecia
Hair loss
Female hair loss
Minoxidil
Topical Steroid
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Skin of Color Society
First posted: 2019-12-23
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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

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.

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.

Primary outcomes:
measure: Central Scalp Alopecia Photographic Scale in African American Women
timeFrame: baseline
measure: Central Scalp Alopecia Photographic Scale in African American Women
timeFrame: Visit 4, Month 6
Secondary outcomes:
measure: Hair Loss Questionnaire
timeFrame: Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
measure: Last Year Dermatology Life Quality Index (LYDLQI)
timeFrame: Baseline
measure: Central Scalp Alopecia Photographic Scale in African American Women
timeFrame: Visit 7, Month 12; Visit 9, Month 18-20
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Department of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Health Department of Dermatology
name: Amy J McMichael, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.