CTRI/2023/10/059282已完成不适用
A double-blind, randomized, single centre, two-arm, placebo-controlled, comparative clinical study to evaluate the safety, in-use tolerability and efficacy of Moisturizing Cream in female subjects with varied skin type.
DPKA Universal Consumer Ventures Private Limited1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Assessment of effectiveness of skin moisturization using MoistureMeterSC
研究概览
简要总结
This is a double-blind, randomized, singlecentre, two-arm, placebo-controlled, comparative clinical study to evaluate thesafety, in-use tolerability and efficacy of a Moisturizing Cream in subjectswith varied skin type.
The potential subjects will be screened as perthe inclusion and exclusion criteria only after obtaining written informedconsent from the subjects.
All eligible subjects will undergo clinicalevaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safetywill be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects with dry / normal / oily / sensitive skin.
- •oSubjects with self-perceived normal skin.
- •oSubjects with dry (readings between 30 – 40) as assessed by MoistureMeterSC.
- •oSubjects with oily skin having Sebumeter measurement > 150 (μg/cm2).
- •oSubjects with sensitive skin based on Dr. Baumann’s skin type questionnaire.
- •Subjects having good general health as determined by the Investigator on the basis of medical history.
排除标准
- •Subjects undergoing treatment for skin lightening or subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Subjects who are receiving topical or systemic treatments.
- •Subjects receiving medications (e.g., steroids or antihistamines) would compromise the study.
- •Chronic illness which may influence the cutaneous state.
- •Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
结局指标
主要结局
Assessment of effectiveness of skin moisturization using MoistureMeterSC
时间窗: Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31
次要结局
- Dermatological assessment of skin dryness using 5-point grading scale(Day 01, Day 08, Day 15, Day 29, Day 31)
- Dermatological assessment of skin radiance using Modified Griffiths Scale(Day 01, Day 08, Day 15, Day 29, Day 31)
- Dermatological assessment of skin roughness using 5-point grading scale(Day 01, Day 08, Day 15, Day 29, Day 31)
- Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using Vapometer(Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31)
- Assessment of skin brightness using Chromameter(Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31)
- Assessment of skin elasticity and firmness using Cutometer(Day 01 (Before application, 4 hours post application), Day 08, Day 15, Day 29, Day 31)
- Assessment of skin roughness using 3D Analysis System(Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31)
- Assessment of Subject Satisfaction Questionnaire(Day 01 (30 mins, 4 hours post application), Day 08, Day 15, Day 29, Day 31)
- Assessment of Product Response Index (Perception about Product)(Day 01 (30 mins post application))
研究者
研究点 (1)
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