NCT05998200已完成不适用
Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Adverse effect after using the serum.
研究概览
简要总结
This study aims to investigate the safety of serum product containing low dose of alpha hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions this study aims to answer are:
- To investigate the safety of serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.
- To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian from 18 to 40 years old.
- •Participants with post-inflammatory hyperpigmentation (PIH).
排除标准
- •Participant with known systemic or skin disease and any underlying medical illness
- •Pregnant, breastfeeding women or planned pregnancy during the study period.
- •Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or known allergies to any ingredients that may be found in the product.
- •Had any cosmetic procedures such as Botox, laser and light treatment, facial surgery, chemical peel and any procedures that may improve skin texture 1 month before the study.
- •Had history of taking isotretinoin for the past 6 or 12 month and AHA (alpha hydroxyl acids) containing products or any other products for treating hyperpigmentation skin or melasma 1 month prior to study.
研究组 & 干预措施
Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
Other
This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.
干预措施: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA (Other)
结局指标
主要结局
Adverse effect after using the serum.
时间窗: Week 8
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
次要结局
- Change in skin pores level(Baseline, Week 4 and Week 8)
- Change in skin tone level(Baseline, Week 4 and Week 8)
- Change in skin moisture level(Baseline, Week 4 and Week 8)
- Change in skin spot level(Baseline, Week 4 and Week 8)
- Participant satisfaction after using the serum for 8 week.(Week 8)
研究者
研究点 (1)
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