CTRI/2025/10/095723尚未招募不适用
Evaluation of the irritation potential of Lip Care Formulations on healthy human subjects having varied skin type
G.D. Pharmaceuticals Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年10月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Dermatological safety / Irritation potential on skin
研究概览
简要总结
Objective:The objective of this study will be to evaluate the irritation potential on healthy human subjects having varied skin of Lip Care Formulations
Kinetics: T0(before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal ), T8 days (T+1 week after 0 hour of patch removal)
Population: 26healthy subjects (13 males + 13 females) .
The test area is checked for erythema and oedema caused due to the products and compared with positive control
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Human Subjects 2.Skin should be healthy on the studied anatomic unit 3)Subjects representing varied skin type types.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give his/her assent by not signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •Being diabetic.
- •Being asthmatic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
- •Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
结局指标
主要结局
Dermatological safety / Irritation potential on skin
时间窗: Baseline,0 hrs,24 hrs and 7 days
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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