A study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-HA35+ serum in subjects with mild to moderate Active Atopic Dermatitis treatment over 12 weeks.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in the PGA score at all timepoints by measuring changes in AD parameters when compared to baseline
研究概览
简要总结
Atopic dermatitis (AD), also known as eczema, is a chronic inflammatory skin condition characterized by pruritic and eczematous lesions. This study is designed to evaluate the effectiveness of Dermapen 4™ microneedling device with MG-HA35+ serum in the treatment of mild to moderate active atopic dermatitis.
Subjects will undergo treatment using Dermapen 4™ microneedling device with MG-HA35+ serum on the baseline visit, weeks 2, 4, 6 and followed up on week 12. Dermatological evaluations for AD severity and IGAI 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 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects in the age group of 18-55 years (both ages inclusive).
- •Subjects with mild to moderate active atopic dermatitis by Physician Global Assessment of score with (PGA score of 2 to 3).
排除标准
- •Subjects with any other skin condition that may impact the assessment.
- •Subjects known to have bleeding and clotting disorders.
- •Subjects who cannot manage AD without medication.
- •Subjects undergoing any other kind of treatment for active Atopic Dermatitis.
- •Subjects known to have connective tissue disorders.
- •Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
- •A known history or present condition of allergic response to any cosmetic products.
- •Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
- •Has used any immunosuppressant drugs, steroids or immunotherapy within the past 30 days.
结局指标
主要结局
Change in the PGA score at all timepoints by measuring changes in AD parameters when compared to baseline
时间窗: Baseline, week 2, week 4, week 6 and week 12.
次要结局
- 1. To evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with the MG-HA35+ serum in the reduction of atopic dermatitis by measure the change in (IGAI) score at all time points in comparison to the baseline.(2. To evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with the MG-HA35+ serum in the reduction of atopic dermatitis by measure change in the intensity of AD score at all time points in comparison to the baseline.)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.