CTRI/2024/12/078461已完成不适用
An evaluator-blind controlled-arm site-randomized split face moisturekinetic study of the test product Saslic Hydra Foaming Face Wash in healthy adult subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. To assess the effectiveness of test product in moisturizing the skin by measuring the skin hydration using Corneometer CM 825.
研究概览
简要总结
An evaluator-blind, controlled-arm, site-randomized, split face moisturekinetic study of the test product “Saslic Hydra Foaming Face Wash†in healthy adult subjects.
Total 32 healthy adult males and non-pregnant/non-lactating females with an age of 18 – 55 years old.
· Visit 01 (Day 01): Screening
· **Visit 02 (Day 02):**Enrolment,Baseline evaluation, On site Product Usage, Post Usage Evaluation, End of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 to 55 years (both inclusive) at the time of consent.
- •2.Sex: Healthy male and non-pregnant/non-lactating females.
- •3.Subject having normal, dry and sensitive skin.
- •4.Females of childbearing potential must have a self-reported negative pregnancy test.
- •5.Subject are generally in good health.
- •6.Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •7.If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •8.Subjects are willing to give written informed consent and are willing to come for regular follow up.
- •9.Subjects who commit not to use any other skincare products for the entire duration of the study.
- •10.Subject who have not participated in a similar investigation in the past three months.
排除标准
- •1.History of any dermatological condition of the skin diseases.
- •2.Subject with present condition of allergic response to any cosmetic product.
- •3.Subject having allergic response to the ink.
- •4.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- •5.Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •6.History of alcohol or drug addiction.
- •7.Subjects using other marketed products during the study period.
- •8.Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •9.Pregnant or breastfeeding or planning to become pregnant during the study period.
- •10.History of chronic illness which may influence the cutaneous state.
- •11.Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
结局指标
主要结局
1. To assess the effectiveness of test product in moisturizing the skin by measuring the skin hydration using Corneometer CM 825.
时间窗: from baseline before usage of the test product on Day 02 and after a single application of the test product 10 mins on Day 02, 2 hours, 4 hours, 8 hours, 12 hours
次要结局
- 1. To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness dermatologist or dermatologist trained evaluators.(2. To assess the effect of the test product in terms of subjective product perception)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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