Comparison of Efficacy of Topical Clascoterone With Topical Adapalene in the Treatment of Mild Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- IGA achievement
研究概览
简要总结
There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting.
Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved.
Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B).
Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks.
Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild acne vulgaris as per operational definition
- •Male or female patients
- •Age 12 to 35 years
排除标准
- •History of acne conglobata
- •History of acne fulminans
- •Use of topical anti-acne medications within the last 4 weeks
- •Use of systemic anti-acne therapy within the last 12 weeks
- •Known hypersensitivity or allergy to clascoterone or adapalene
- •History of eczema
- •History of rosacea
- •History of seborrheic dermatitis
- •History of psoriasis
- •Presence of active skin infections
- •Pregnant women
- •Lactating women
研究组 & 干预措施
Topical adapalene 0.1 percent gel
干预措施: Adapalene 0,1% cgel (Drug)
topical CLASCOTERONE 1 percent cream
干预措施: Clascoterone Cream 1% (Drug)
topical CLASCOTERONE 1 percent cream
干预措施: Adapalene 0,1% cgel (Drug)
Topical adapalene 0.1 percent gel
干预措施: Clascoterone Cream 1% (Drug)
结局指标
主要结局
IGA achievement
时间窗: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
investigator global assessment achievement of 0 which is clear face or 1 which is almost clear
Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment
时间窗: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
Investigator global assessment scoring
次要结局
未报告次要终点
研究者
Haider Ali
Principal investigator
Khyber Teaching Hospital