CTRI/2013/02/003430已完成4 期
Evaluation and comparison of efficacy and in use skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w) in patients with mild to moderate psoriasis
Curatio Healthcare Pvt Ltd3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年2月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- •Clinical Evaluation using LASI scale.
研究概览
简要总结
- This is a test under supervision of dermatologist, multricentric, double blinded, randomized, comparative – versus initial state and each other.
- At Visit 1 Day 0, lesion will be clinically evaluated using the LASI scale and digital photographs will be taken.
- Evaluation for in use skin safety will be done at Visit 2 (10 days), Visit 3 (20 Days) and Visit 4 (30 days).
- Clinical evaluation and digital photographs will be taken at all visits. All photographs will be taken in such a manner that the identity of the volunteer would not be revealed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Voluntary men/women with clinically diagnosed mild to moderate stable, chronic, plaque psoriasis.
- •2.At least one, discrete, well circumscribed lesion approximately 20 cm2 – 80 cm2 on trunk separated from adjacent lesions by at least 3 cms.The same lesion will be tracked through the entire study.
- •3.Age between 18 – 55 years 4.Not on treatment for psoriasis- oral since 1 month and topical since 2 weeks.
- •5.Accepting not to use products with the same end benefit during the entire study duration.
- •6.Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •7.Having signed a Consent Form and will be informed orally and in writing of all information concerning the study procedures and study objectives.
排除标准
- •1.Pustular psoriasis, Palmoplanter and erythrodermic psoriasis.
- •2.Pregnant women (as confirmed by UPT) and lactating women.
- •3.History of allergic dermatitis or contact allergy to cosmetics, 4.Hypersensitivity to any cosmetic product, raw material.
- •5.For whom the Investigator considers that he/she will not be compliant with study procedures.
- •6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •8.Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.
结局指标
主要结局
•Clinical Evaluation using LASI scale.
时间窗: •Day 0, 10 days,20 days and 30 days
次要结局
- In use skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w).(•Day 0, 10 days,20 days and 30 days)
研究者
研究点 (3)
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