Does Carboxytherapy Play a Role in Alopecia Areata Either Solely or in Combination? Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severity of Alopecia Tool (SALT) score
研究概览
简要总结
Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion.
Treatment period is 3 months followed by a follow-up period of 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •early localized scalp alopecia areata
- •patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent.
排除标准
- •pregnant, and lactating females and those with unrealistic expectation.
- •Alopecia totalis or universalis or ophiasis or cicatrising alopecia
- •Usage of systemic treatment of alopecia areata 2 months prior to the study.
- •Any scalp lesion within the treated area
- •Bleeding diathesis, severe anemia or platelet disorders
- •Medical conditions such as autoimmune diseases.
研究组 & 干预措施
Carboxytherapy
干预措施: Carboxytherapy (Device)
Intralesional steroids
干预措施: Intralesional Steroid Injection (Drug)
Combination of carboxytherapy and intralesional steroids
干预措施: Carboxytherapy (Device)
Combination of carboxytherapy and intralesional steroids
干预措施: Intralesional Steroid Injection (Drug)
结局指标
主要结局
Severity of Alopecia Tool (SALT) score
时间窗: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both Minimum value is 0% and maximum value is100% the higher the score the more the hair loss
Dermoscopy
时间窗: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both through counting number dystrophic hair, tapered hair, regrowing hair, black dots, and yellow dots
blinded observer evaluation by use of photography
时间窗: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
patient satisfaction rate
时间窗: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
次要结局
未报告次要终点
研究者
Rana F Hilal, MD
Lecturer of dermatology, faculty of Medicine, Cairo University.
Kasr El Aini Hospital