A open label, clinical study to evaluate the efficacy and safety of hair removal spray on healthy adult subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Hair count reduction in the applied area by comparing with Photographs.
研究概览
简要总结
· Study Objective: To evaluate the efficacy, safety, and tolerability of a hair removal spray.
· Study Design:
ü 30 participants (15 males, 15 females)
ü Hair removal spray applied for 8-10 minutes, followed by depilation.
ü 24-hour follow-up to assess efficacy and allergic reactions.
ü Outcome Measurement Timeline: 24-hour follow-up after product use.
· Primary Outcome Measures:
1. Hair count reduction by photographic comparison.
2. Subject comfort assessed using a VAS scale.
3. Satisfaction with hair removal and improvement using a 10-point scale.
4. Skin irritation (erythema and edema) evaluated via Draize’s scale.
5. Product application feedback: ease of use, stickiness, greasiness, spreading, fragrance preferences.
· secondary Outcomes Measures :
1. Monitoring of adverse events and serious adverse events during the study.
2. Brief clinical examination for allergic reactions or irritations.
· Participant Criteria:
1. Inclusion:
§ Healthy adults aged 18-60.
§ Moderate hair growth on forearm, legs, and pubic area.
§ No cuts, marks, or open wounds.
§ No use of similar products in the last 4 weeks.
2. Exclusion:
§ Pre-existing dermatologic conditions (e.g., psoriasis, eczema).
§ Vulnerable groups (children, elderly >80, mentally challenged).
§ Known allergies or sensitivities to cosmetic products or its ingredients.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in generally good health
- •Subjects in the age group of 18-60 years.
- •Subjects with moderate hair growth on forearm, legs and pubic area.
- •Subjects without any cuts, marks and open wounds on forearm, legs and pubic area.
- •Subjects have not used a similar product for the last four weeks.
排除标准
- •Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema and severe excoriations).
- •Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, etc.
- •History of allergy to the test product.
结局指标
主要结局
1. Hair count reduction in the applied area by comparing with Photographs.
时间窗: Visit 1 (day 1) and visit 2 (Day 2)
2. Subjects assessment of comfort associated with treatments using a VAS scale. Subjects satisfaction with hair removal treatments and assessment of improvement using a ten point scale.
时间窗: Visit 1 (day 1) and visit 2 (Day 2)
3. The skin will be evaluated for signs of irritation identified under Erythema and odema, using Draizes scale.
时间窗: Visit 1 (day 1) and visit 2 (Day 2)
4. a. Ease of application or usage b. Stickiness c. Greasiness and d. Ease of spreading.
时间窗: Visit 1 (day 1) and visit 2 (Day 2)
5. Product evaluation and product performance feedback questions will be obtained from the participants.
时间窗: Visit 1 (day 1) and visit 2 (Day 2)
次要结局
- To demonstrate safety and tolerability of study product by Clinical AEs (If any)
研究者
Dr Sakthi Balan
DK Elite Health Care Centre