An exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To evaluate the safety and effectiveness of test product in terms of change in :
研究概览
简要总结
This exploratory, prospective, open-label, randomized~~,~~ three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.
- Visit 01 : Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation
- Visit 02 : Evaluations, Product usage period
- Visit 03 : Product Usage Period, Evaluations
- Visit 04 : Evaluations, End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy male and non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •Subject with dry and sensitive skin at a time of screening.
- •(Dermatological Assessment) 6) Subjects forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites.
- •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.
- •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.
- •Subjects are willing to give written informed consent and are willing to come for regular follow up.
- •Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
- •Subject who have not participated in a similar investigation in the past three months.
排除标准
- •History of any dermatological condition of the skin diseases.
- •Subject with present condition of allergic response to any cosmetic product.
- •Subject having allergic response to the ink.
- •any areas of broken/chapped/cut/irritated/scraped skin.
- •Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- •Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical or cosmeceuticals, herbal treatment.
- •History of alcohol or drug addiction.
- •Subjects using other marketed products during the study period.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •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
To evaluate the safety and effectiveness of test product in terms of change in :
时间窗: from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.
1. skin hydration
时间窗: from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.
2. DASI score
时间窗: from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.
3. overall dry skin score
时间窗: from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.
4. skin barrier function
时间窗: from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.
5. skin roughness, skin scaliness, skin smoothness, and skin wrinkles.
时间窗: from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.
次要结局
- To assess the effectiveness of the test product in terms of change in desquamation index(from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.)
- To assess the effectiveness of the test product in terms of change in PGA score(score from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.)
- To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness(from baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08, Day 30 and Day 60.)
- To assess the effect of the test products in terms of product perception(after usage of the test products from baseline before usage of the test product on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08, Day 30 and Day 60.)
- Safety will be determined by product-emergent adverse events such as stinging, burning, irritation, dryness, or redness at the application site assessed by the Dermatologist/Study Physician.(on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 , Day 30 and Day 60.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited