Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Central Scalp Alopecia Photographic Scale in African American Women
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Topical steroid plus oral antibiotic group
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.
干预措施: Topical steroid class I-II (Drug)
Topical steroid plus oral antibiotic group
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.
干预措施: Doxycyline (Drug)
Topical steroid plus oral antibiotic group
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.
干预措施: Minoxidil (Drug)
Topical steroid plus intralesional steroid injection group
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
干预措施: Topical steroid class I-II (Drug)
Topical steroid plus intralesional steroid injection group
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
干预措施: Triamcinolone Acetonide (Drug)
Topical steroid plus intralesional steroid injection group
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
干预措施: Minoxidil (Drug)
结局指标
主要结局
Central Scalp Alopecia Photographic Scale in African American Women
时间窗: Visit 4, Month 6
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.
次要结局
- Hair Loss Questionnaire(Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20)
- Dermatology Life Quality Index (DLQI)(Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20)
- Last Year Dermatology Life Quality Index (LYDLQI)(Baseline)
- Central Scalp Alopecia Photographic Scale in African American Women(Visit 7, Month 12; Visit 9, Month 18-20)