CTRI/2022/04/042030暂停不适用
A Single Center, Application Site Randomized, Evaluator-Blinded, Moisturization Study to Evaluate the Moisturization Properties of Test Products in Healthy Adult Human Subjects.
Duosis BioInnovations Pvt Ltd1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年4月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Skin moisture i.e., hydration state of the skin by Corneometer CM 825 or MoistureMeterSC
研究概览
简要总结
The aim of this observational study is determined the effect of moisturizers properties of various skincare products on all skin types in healthy adults’ subjects. The proposedbenefits are evaluated by the dermatologist/dermatologist trained evaluator andassessment questionnaire at 24 hours after test product application. Theinstrumental evaluation of skin hydration will be done at beforeapplication to 1 hour (+15mins), 4 hours (+15mins), 8 hours (+15mins), and 24hours (+15mins) after application of 4 skin careproducts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •1.Subject between ages of 18 to 65 (both inclusive) years old at the time of consent.
- •2.Gender: Males and non-pregnant, non-lactating females.
- •3.Female subjects of childbearing potential must have a negative urine pregnancy test performed on Screening visit and Enrolment.
- •4.Subject general in good health as determined from a recent medical history.
- •5.Subject is willing to participate in the study, give a voluntary written informed consent.
- •6.Subjects willing to abide by and comply with the study protocol.
- •7.Subjects should not participate in any other clinical study during participation in the current study.
排除标准
- •1.Use of Body milk /lotion / cream, cosmetics or any other body moisturizing product before 3-5 days prior to study and during the study period.
- •2.Chronic illness which may influence the cutaneous state.
- •3.Subjects on any systemic medication.
- •4.Subject with history of diabetes.
- •5.Subjects participating in a similar clinical study, currently or during the previous 30 days.
- •6.Any subjects, in the Investigator opinion not considered suitable for enrollment.
- •7.A known history or present condition of allergic response to any other concern that may require medical attention.
- •8.Subjects with medical history (past/present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g., porphyria) chronic urticaria, or sunburn, rashes.
- •9.Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. volar forearm that can interfere with the reading.
结局指标
主要结局
Skin moisture i.e., hydration state of the skin by Corneometer CM 825 or MoistureMeterSC
时间窗: Baseline i.e., Day 1 before application, T1 hour (plus 15mins), T4 hours (plus 15mins), T8 hours (plus 15mins) after application on Day 1 and T24 hours (plus 15mins) after application on Day 2.
次要结局
- Skin physical parameter by Dermatologist | Dermatologist Validated Scorer using 5-point scoring scale for skin dryness, skin roughness, skin redness/erythema, burning, itching and stinging and 8-point scoring scale for skin suppleness and softness(Baseline i.e., Day 1 before application, T1 hour (plus 15mins), T4 hours (plus 15mins), T8 hours (plus 15mins) after application on Day 1 and T24 hours (plus 15mins) after application on Day 2.)
- Product response index (perception about product)(T24 hours (plus 15mins) after application on Day 2)
研究者
研究点 (1)
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