An interventional clinical trial to evaluate the efficacy and safety of 3 peel sessions of Activa Peel Forte and Mela Peel Forte combined with Dermaceutic homecare products in adults with skin of color suffering from melasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Efficacy of chemical peel combined with at home skincare regimen in treating melasma through dermatological evaluation, instrumental evaluation and digital imaging
研究概览
简要总结
Melasma is a common hyperpigmentation disorder characterized by irregular, dark, discolored patches primarily appearing on the face often influenced by factors such as sun exposure, hormonal changes, genetics, and certain medications. Treatment for melasma is often tailored based on the severity and the underlying cause chemical peels have become a popular, non-invasive solution for the treatment of melasma.
This study aims to evaluate the efficacy and safety of Activa Peel Forte and Mela Peel Forte combined with dermaceutic homecare products in adults with skin of colour suffering from melasma.
The study will be conducted over 14 weeks and will include five visits: Visit 1 (screening), followed by four assessment visits (Visit 2, Visit 3, Visit 4, and Visit 5).
During the screening visit, participants will undergo a dermatological assessment to confirm the presence of melasma. Eligible participants will receive test products, a subject diary, and detailed instructions on their usage.
At each assessment visit, dermatological evaluations, imaging assessments, safety evaluations, and instrumental assessments will be performed to monitor progress and evaluate outcomes. Additionally, chemical peel procedures will be included during visit 2, 3, 4.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant with Melasma.
- •Participant free of excessive hair, acne, wounds or any other active skin conditions on face.
- •Participant who agrees not to participate in any other clinical research
- •Participant with skin phototype IV to VI according to Fitzpatrick scale
- •Participant willing to refrain from using any other product/ home remedies that could affect the skin, aside from the study products.
排除标准
- •Participant with dry and sensitive skin.
- •Female participant who are pregnant or lactating.
- •Participant who has taken any oral medications or systemic corticosteroids, anti-fungal, antibiotics, hormonal therapy (including oral contraceptives), or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within 4 weeks prior to the study.
- •Participant who has undergone any dermatological procedure or facial surgery which might interfere in the study based on investigator’s assessment.
结局指标
主要结局
Efficacy of chemical peel combined with at home skincare regimen in treating melasma through dermatological evaluation, instrumental evaluation and digital imaging
时间窗: Visit 2 | Visit 3 | Visit 4 | Visit 5
次要结局
- Evaluation of safety and tolerability of chemical peel by the collection of adverse event and participants questionnaires.(Visit 2)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd