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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Central Centrifugal Cicatricial Alopecia (CCCA)

Intervention / Treatment
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* Drug: Topical steroid class I-II
* Drug: Triamcinolone Acetonide
* Drug: Doxycyline
* Drug: Minoxidil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical steroid plus oral antibiotic group<br>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<br>* applied once daily - 18 month duration of the study<br>* Other names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide;Drug: Doxycyline<br>* oral antibiotic twice daily for 6 months<br>* Other names: Oracea;Drug: Minoxidil<br>* 5% solution or foam started after month 8<br>* Other names: Rogaine;|
| Active Comparator: Topical steroid plus intralesional steroid injection group<br>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<br>* applied once daily - 18 month duration of the study<br>* Other names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide;Drug: Triamcinolone Acetonide<br>* 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.<br>* Other names: Kenaolog;Drug: Minoxidil<br>* 5% solution or foam started after month 8<br>* Other names: Rogaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Visit 4, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Visit 7, Month 12; Visit 9, Month 18-20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia, Hair loss, Female hair loss, Minoxidil, Topical Steroid