A clinical study to evaluate safety, in-use tolerability and efficacy of Purifying Neem Face Wash in healthy subjects with mild to moderate acne and acne prone skin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- To assess the efficacy of test product on acne or acne prone skin, based on clinical, instrumental and subjective evaluations done at predetermined time points.
研究概览
简要总结
This is an open label, non-randomized, single-arm clinical study to evaluate safety, in-use tolerability and efficacy of Purifying Neem Face Wash in healthy subjects with mild to moderate acne and acne prone skin.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with mild to moderate acne condition.
- •OR Subjects who are prone to develop however with no existing acne.
- •Subjects with oily skin having Sebumeter measurement more than 150 (ug/cm2).
- •Subjects with acne marks/spots and post acne scar.
- •Subjects with visible facial pores.
排除标准
- •Subjects with drug induced acne as disclosed by subjects.
- •Subjects undergoing treatment for skin lightening or using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Subjects who are receiving topical or systemic treatments for acne, acne marks and acne scars.
- •Subjects receiving medications (e.g., steroids or antihistamines) would compromise the study.
- •Chronic illness which may influence the cutaneous state.
结局指标
主要结局
To assess the efficacy of test product on acne or acne prone skin, based on clinical, instrumental and subjective evaluations done at predetermined time points.
时间窗: Day 01 (before application and 15 mins), Day 02 (24hrs), Day 03 (48 hrs), Day 04 (72 hrs), Day 05 (+ 01 day), Day 07 (+ 02 days), Day 15 (+ 02 days) and Day 29 (+ 02 days).
次要结局
未报告次要终点
研究者
Dr Bhagirath Patel
Cliantha Research