A monocentric open label prospective clinical study to assess the anti acne efficacy of the Anti pimple Face Oil in healthy adult human male and female subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Visible reduction in acne appearance at Day 3 (For Group A) & at Day 20 (For Group B)
研究概览
简要总结
A monocentric, open-label, prospective clinical study. Twenty-four healthy adult male & female subjects in the age group of 18 to 45 years will be selected according to inclusion and exclusion criteria & having mild to moderate acne.
The objective of this prospective, open-label, single-centre study is to evaluate the efficacy and tolerance of twice daily application for 3 days (For Group A) & 20 days (For Group B) ofAnti pimple Face Oil on healthy adult male & female subjects.
This study will be conducted over a treatment period of 3 days (For Group A) and 20 days (For Group B) as per the treatment regimen groups. The dermatological evaluation and subject self-evaluation will be performed at the test site at Day 0 (Baseline before product evaluation), Day 1, Day 3 for Group A and Day 0 (Baseline before product evaluation), Day 10 and Day 20 for Group B.
Test site images will also be taken at Baseline (Day 0) & Day 3 for Group A and at Baseline (Day 0) and Day 20 for Group B. Subject feedback will be taken at Day 3 and Day 20 for Group A and Group B respectively. BO International is the manufacturer for the Anti pimple Face Oil for Eliea Wellness.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male & female subjects in the age group of 18-45 years (both age inclusive) Subject is having valid proof of identity and age Subject is having apparently healthy skin on test area Subjects must have a facial acne score of 1to 2 (For Group A) that will be clinically determined to be mild and a score of 2 to 3 (Group B) clinically determined to be clinically to be mild to moderate.
- •Subjects having 1- 3 inflammatory active lesions for (Group A) and 3-10 inflammatory active lesions (For Group B).
- •No treatment for acne/facial in the past 1 month.
- •Subjects willing to give voluntary written informed consent.
- •Subjects willing to come for regular follow up visits Subjects ready to follow instructions during the study period Subjects without any open wounds, cuts, abrasions, irritation symptoms on test area.
排除标准
- •Subjects with Known hypersensitivity to any of the study products or constituents Subjects who is using any oral or topical prescription or over-the-counter (OTC) acne treatments (and topical retinoids) within the past 30 days Dark spots and post acne scars on the test area.
- •Subjects with any kind of skin allergy, antecedents or cutaneous disease or any significant pathology in the test area which may influence the study results.
- •Subjects having topical or systemic treatment in last month prior to participation in the study and during the study that could interfere with the study treatments/ assessments Subject is Pregnant or Lactating Subject with any significant medical condition that would interfere with the participation in the trial Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation Subject is having Scars, excessive terminal hair or tattoos on the test area.
结局指标
主要结局
Visible reduction in acne appearance at Day 3 (For Group A) & at Day 20 (For Group B)
时间窗: Group A Day 0 Day 1 Day 3 | Group B Day 0 Day 10 Day 20
Notable reduction in the lesion count, specifically in the number of papules and pustules
时间窗: Group A Day 0 Day 1 Day 3 | Group B Day 0 Day 10 Day 20
Assessment of lesion size, skin smoothness, overall redness of inflammatory lesions, overall size of inflammatory lesions, comedogenic potential of the test product.
时间窗: Group A Day 0 Day 1 Day 3 | Group B Day 0 Day 10 Day 20
Percentage of subjects who achieved full relief from facial acne at Day 3 (For Group A) & at Day 20 (For Group B).
时间窗: Group A Day 0 Day 1 Day 3 | Group B Day 0 Day 10 Day 20
次要结局
- • Safety & Tolerability of the investigational product during the entire study duration of 3 Days (For Group A) & 20 Days (For Group B)(Group A Day 0 Day 1 Day 3)
研究者
Dr Karishma Kapoor
Auriga Research Private Limited