A multicentric, full face, baseline-controlled study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-EXO-SKIN serum for rosacea treatment over 20 weeks.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 3
研究概览
简要总结
Rosacea is a common chronic inflammatory skin disorder primarily affecting the face with a global prevalence of 5.5%. It is characterized by flushing, non-transient erythema, papules/pustules, telangiectasia, and phymatous changes. Secondary manifestations, such as itching, burning, or stinging, are also often observed in affected individuals. This study has been designed to evaluate the effectiveness of Dermapen 4™ microneedling device in conjunction with MG-EXO-SKIN serum in the treatment of rosacea. Participants will undergo treatment using Dermapen 4™ microneedling device with MG-EXO-SKIN serum on the baseline visit, weeks 4, 8, 12,16 and followed up on week 20. Dermatological assessments for rosacea severity using IGA scores and Clinician Severity Assessment Grading Scale on Erythematotelangiectatic Rosacea will be done at all defined time points.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female trial participants aged between 18-50 years (both ages inclusive).
- •Trial participants having mild to moderate rosacea based on IGA scale for rosacea.
- •Trial participants having Fitzpatrick skin phototypes III to VI.
排除标准
- •Trial participants with rosacea fulminans/ conglobate.
- •Trial participants with any known skin condition that may impact the assessment.
- •Trial participants known to have bleeding and clotting disorders.
- •Trial participants known to have connective tissue disorders.
- •Trial participants who are pregnant or nursing (self-declared).
- •Trial participants with skin allergy history or atopic dermatitis or psoriasis.
- •Trial participant who is an employee of the sponsor or the CRO.
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt Ltd