Central Centrifugal Cicatricial Alopecia (CCCA)
Conditions
Keywords
alopecia, Hair loss, Female hair loss, Minoxidil, Topical Steroid
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.
Interventions
DRUGTopical steroid class I-II
applied once daily - 18 month duration of the study
DRUGTriamcinolone 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.
DRUGDoxycyline
oral antibiotic twice daily for 6 months
DRUGMinoxidil
5% solution or foam started after month 8
Sponsors
Wake Forest University Health Sciences
The Skin of Color Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Scalp Alopecia Photographic Scale in African American Women | baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair Loss Questionnaire | Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20 | 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. |
| Dermatology Life Quality Index (DLQI) | Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20 | 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. |
| Last Year Dermatology Life Quality Index (LYDLQI) | Baseline | 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 Scalp Alopecia Photographic Scale in African American Women | Visit 7, Month 12; Visit 9, Month 18-20 | 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. |
Countries
United States
Contacts
CONTACTAmy J McMichael, MD
CONTACTJudy Holbrook, CRC
PRINCIPAL_INVESTIGATORAmy J McMichael, MD
Wake Forest Baptist Health Department of Dermatology
Outcome results
None listed