CTRI/2022/09/045434已完成不适用
An Open Label, Single-Arm, Clinical Study to evaluate the Effectiveness of a Moisturizer on Skin Moisturization in adult subjects with mild to moderate acne.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of test product in improving the skin moisturization using Corneometer® CM 825 / MoistureMeterSC
研究概览
简要总结
This is an openlabel, single-arm, clinical study to evaluate the effecttiveness of a Moisturizer on skin moisturization in adultsubjects with mild to moderate acne.
The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.
There are total6 visits in the study i.e.,
Visit 01: Screening Visit (Within 30 Days Prior to Day 1)
Visit 02: Enrollment (Day 01)
Visit 03: Evaluation Phase (Day 15 ± 02 Days)
Visit 04: Evaluation Phase (Day 30 ± 02 Days)
Visit 05: Evaluation Phase (Day 45 ± 02 Days)
Visit 06: Evaluation Phase and End of Study (Day 60 ± 02Days)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 to 35 years (both inclusive) at the time of consent.
- •2.Sex: Adult male and non-pregnant/non-lactating female.
- •3.Subjects with acne-prone skin and with mild to moderate acne condition as per IGA scale for Acne severity.
- •4.Subjects with oily skin having Sebumeter measurement > 180 (µg/cm2).
- •5.Subjects with acne marks/spots and visible pores.
排除标准
- •1.Subjects with drug induced acne as disclosed by subjects.
- •2.Subjects undergoing treatment for skin lightening.
- •3.Subjects who are receiving topical or systemic treatments.
- •4.Subjects with any pigmentary disorder including freckles and melasma.
- •5.Subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
结局指标
主要结局
To evaluate the effectiveness of test product in improving the skin moisturization using Corneometer® CM 825 / MoistureMeterSC
时间窗: Day 01 (before application) and Day 15 (plus minus 2 days)
次要结局
- To evaluate the effectiveness of test product in improving the skin moisturization using Corneometer® CM 825 / MoistureMeterSC(Day 01 (before application), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate the effectiveness of test product in preventing the appearance of new acne by using Investigator’s Global Assessment (IGA) Scale for Acne Vulgaris(Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate the effectiveness of test product in reducing skin redness using 5-point scale by Dermatologist(Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate the effectiveness of test product in Restoring/ Improving the skin barrier function by measuring Transepidermal Water Loss (TEWL) using TEWAmeter® TM300 / Vapometer(Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate the effectiveness of test product on reduction of skin sebum level using Sebumeter® SM 815(Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To assess the Subject Satisfaction Questionnaire after product usage(Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate the effectiveness of test product on acne reduction by using Investigator’s Global Assessment (IGA) Scale for Acne Vulgaris(Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate the effectiveness of test product on acne using 3D analysis system(Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- To evaluate Subject Response Index (Perception about Product) after product usage(Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days))
- Exploratory Endpoints:(10.1 To evaluate the effectiveness of test product in reducing skin pigment using 9-point scale by Dermatologist.)
研究者
研究点 (1)
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