NCT06602284尚未招募2 期
A Full Face, Baseline Controlled Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Conjunction with MG-CLR Serum for Acne Treatment Over 12 Weeks.
Equipmed USA LLC2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acne severity
研究概览
简要总结
This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects aged between 18-45 years (both ages inclusive)
- •Fitzpatrick skin phototype I to VI.
- •Subjects having IGA score of 2 and
- •Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
- •Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
- •Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period
排除标准
- •Subjects with known skin condition that may impact the assessment.
- •Subjects with active Herpes labialis infection.
- •Subjects known to have bleeding and clotting disorders (self-declared).
- •Subjects known to have connective tissue disorders.
- •Subjects with any other signs of significant local irritation or skin disease.
- •Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
结局指标
主要结局
Acne severity
时间窗: 13 weeks
Change in acne severity using the modified GAGS scale at all time points when compared to baseline.
次要结局
未报告次要终点
研究者
研究点 (2)
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