A monocentric, double blinded, single group, non-randomized comparative study to evaluate in use tolerance of a test product versus marketed product in healthy participants.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1. Hydration measurements
研究概览
简要总结
Tretinoin is also known as retinoic acid. It’s the generic name for synthetic vitamin A. It’s sold
under many different brand names. Tretinoin can be a safe, effective treatment option for acne.
It can also help reduce the appearance of surface wrinkles and dark spots due to sun damage.
Common side effects of tretinoin include red, dry, or peeling skin, burning or itching near the
application site and skin that feels warm to the touch.
The test product contains an ingredient HYDROSELLA which is claimed to prevent dryness on
site after application, whereas the control product does not contain any such ingredient.
Hydrosellaâ„¢ is an organic extract from the calyx of a unique genotype of Hibiscus sabdariffa L.
It Increases organic osmolytes and their specific transporters (TauT) for higher keratinocytes
water intake. It Re-hydrates dry skin cells to protect and fight against cell shrinkage caused by
drying. It also Improves the skin barrier function to reduce further water loss. Clinical study
conducted using single application of HYDROSELLA, in 10 female volunteers with normal to dry
skin, with Single application of 1% Hydrosellaâ„¢ gel on forearms, (Measurement at 1h, 24h,
48h, 72h, Skin hydration by corneometry, Skin water loss by TEWL). It was found to rapidly
increases skin hydration and reduces skin water loss. Long term action, study was conducted in
10 active men, for 28 days of a gel containing of Hydrosella. Skin hydration improved by 20% &
TEWL reduced by 17% compared to placebo.
Therefore, this this study is planned to verify the effect of test formulation containing
Hydrosella in preventing dryness of skin as compared to control tretinoin product.
Result: The study was completed with 33 complete cases and no adverse events were reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary men and /or women ≥ 18 years of age.
- •50 % Dry skin type (MoistureMeter SC Readings < 20) and 50% normal skin type.
- •Having signed a Consent Form after the study has been explained orally and in writing, of all information concerning the study procedures and study objectives.
- •Presenting healthy skin on test sites.
- •Cooperating informed of the need and duration of the examinations.
排除标准
- •Pregnant women by UPT, Lactating mothers.
- •Allergic to any cosmetic product.
- •A participant who the Investigator feels will not be compliant with study requirements.
- •Any type of skin disorder which Investigator feels will interfere with the study
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •E.g. topical steroids.
- •Chronic illness which may influence the skin sensitivity (skin problems like atopic dermatitis, psoriasis, eczema or diseases like hypothyroidism, anaemia, hormonal problems, or patients on anti-cholesterol drugs, etc)
- •Any cutaneous disease which would predispose to dry skin (confirmed by prior history).
- •Any cutaneous conditions on test site (scars, moles, papules etc).
- •Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
结局指标
主要结局
1. Hydration measurements
时间窗: 0 hour, 1 hour, 6 hour, 15 days, 30 days
2. TEWL measurements
时间窗: 0 hour, 1 hour, 6 hour, 15 days, 30 days
次要结局
- 1. Clinical evaluation for tolerance(2. Overall tolerance on 10 point VAS)
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.)