A Prospective, Double Arm, Comparative, Clinical Study To Evaluate The Efficacy And Safety Of GLAZE SCAR CLEARING GEL With Mederma Scar Gel In Patients With Recent Scars.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- -Mexameter (Marked scar)- pre and post study
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 30 Participants will be randomized into two groups with 15 in each.
The application of the product will be done at each site on each day of assessment/ throughout the study period by the subject. Subject will wash their test area with a water prior to the application. After pat dry, the test product will be applied on the entire scar area of each application ( approximately 8-12 hours apart) twice daily throughout the study duration. After application, the subject should not wash their test site for at least 2 hours with water or any other product. Subjects will avoid unnecessary sun exposure immediately after morning product application. The daily application of the test product will be recorded in the subject dairy. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of day 30, day 45, day 60 and any other additional visits if needed.
Primary and Secondary Outcome
1)VAS Score
-
Skin Moisture
-
Skin Scar Lightening
-
Skin Clarity
-
Skin Smoothening
-
Overall improvement of skin health
-
In terms of Burning/ Itching
-
Instrumental Assessment- Mexameter, Cutometer
-
Subject Assessment
-
Cosmetic Assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects in the age group of 18-50 years
- •Subject having visible recent scars (Face region) because of any trauma, acne, dermatitis, Accidental scar, Surgery Scar and Scars after pregnancy.
- •Subject is having apparently healthy skin without any open wounds, cuts, abrasions, irritation symptoms on test area.
- •Subjects willing to give voluntary written informed consent.
- •Subjects willing to come for regular follow up visits
- •Subjects willing to avoid unnecessary sun exposure during the study period and willing to use Sun screens.
排除标准
- •Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
- •Subjects diagnosed with scleroderma.
- •Subjects with any kind of skin allergy or cutaneous disease which may influence the study results.
- •Subject with any significant medical condition/ severe co-morbid disease conditions that would interfere with the participation in the trial
- •Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation
- •Subjects having undergone facial treatments like bleaching or laser in last 30 days.
- •Hypersensitivity to any of the ingredients of the test product.
- •Pregnant or lactating women
- •Patients on steroid therapy or any other immunomodulatory agents.
结局指标
主要结局
-Mexameter (Marked scar)- pre and post study
时间窗: DAy 0,DAy 30 and Day 60
-Cutometer (Marked scar)- pre and post study
时间窗: DAy 0,DAy 30 and Day 60
1.Instrumental Assessment–
时间窗: DAy 0,DAy 30 and Day 60
2. Vas Scar scoring
时间窗: DAy 0,DAy 30 and Day 60
3. Skin moisture
时间窗: DAy 0,DAy 30 and Day 60
4. Skin brightening
时间窗: DAy 0,DAy 30 and Day 60
5. Skin smoothening
时间窗: DAy 0,DAy 30 and Day 60
次要结局
- Outcome TimePoints(Patient and Investigator Feedbacks will be obtained)