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

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 4

Conditions: Central Centrifugal Cicatricial Alopecia (CCCA)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04207931

IRB00043796

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Topical steroid plus oral antibiotic group

Active Comparator group

Description:

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.

Treatment:

Drug: Minoxidil

Drug: Doxycyline

Drug: Topical steroid class I-II

Topical steroid plus intralesional steroid injection group

Active Comparator group

Description:

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

Treatment:

Drug: Minoxidil

Drug: Triamcinolone Acetonide

Drug: Topical steroid class I-II