Efficacy of 15% trichloroacetic acid peel versus 35% glycolic acid peel in acanthosis nigricans - a randomized open label study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ∙ Proportion of patients with Physician Assessment Score (PAS) more than 2 in the two groups. ∙ Improvement in mean ANASI Score in two groups.
研究概览
简要总结
Acanthosis nigricans is the disorder in which the skin becomes darkened, thickened and velvety in textured. It is quite distressful for the patient. Very few studies are available which have documented the efficacy of various treatment options for the same. Therefore the aim of the study is to observe the efficacy of the treatment options routinely offered to the patient with acanthosis nigricans.
There will be two group of patients, one will receive 15% trichloroacetic acid peel and other will receive 35% glycolic acid peel. Patients will be randomly allocated in one of the group. 3 sessions of peeling will be performed at an interval of 2 weeks. Following observations will be made.
-
Proportion of patients with Physician Assessment Score more than 2 in the two groups.
-
Improvement in mean ANASI score in two groups.
-
Mean Patient Satisfaction Score after 3 session in the two groups.
-
Proportion of patients experiencing adverse effects in two groups.
Data will be analyzed using freely available analytical software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult population in the age group of 18 years and above with clinical diagnosis of acanthosis nigricans involving face or neck or elbow or any combination of these three presenting to dermatology outpatient department at Smt Sucheta Kriplani Hospital.
排除标准
- •âˆ™ Pregnant and lactating females.
- •âˆ™ Hypersensitivity to peeling agent.
- •âˆ™ Skin infection at the site of acanthosis nigricans ( Herpes, pyoderma, folliculitis) ∙ Individual prone to keloid formation ∙ History of any topical application in last 4 weeks.
结局指标
主要结局
∙ Proportion of patients with Physician Assessment Score (PAS) more than 2 in the two groups. ∙ Improvement in mean ANASI Score in two groups.
时间窗: At baseline, 2, 4, 6, 8 weeks
次要结局
- ∙ Mean Patient Satisfaction Score after 3 sessions in the two groups.(4,6,8 weeks)
- ∙ Proportion of patients experiencing adverse effects in two groups.(4, 6, 8 weeks)