The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry.
研究概览
简要总结
This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.
详细描述
This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.
Inclusion Criteria:
- Healthy male and non pregnant female subjects ≥18 years of age
- have seborrheic keratoses on the right and left chest and/or back
Exclusion Criteria:
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 18-70 years of age, of any race or sex.
- •Subjects must be Fitzpatrick skin type I-VI.
- •Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.
排除标准
- •Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
- •Subjects with known history of keloids or hypertrophic scars.
结局指标
主要结局
Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry.
时间窗: 10 weeks
次要结局
未报告次要终点