A randomized, double-blind, placebo controlled, monocentric study to evaluate the Anti Ageing efficacy and safety of Olepent® cream in Healthy female subjects.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1 Mean reduction in facial fine line, wrinkles and elasticity as assessed by Antera & Dermatological visual assessment
研究概览
简要总结
In this trial the efficacy andsafety of Olepent® will be evaluated in healthy female volunteersaged 35 to 50 years (both inclusive) with Fitzpatrick skin types III to V.Approximately 56 subjects will be enrolled, 24 subjects in each cohort areexpected to complete the study. The study duration will be eight weeks foreach subject. The primary endpoints for the study will be mean reduction infacial fine lines, wrinkles and elasticity as assessed by Antera &Dermatological visual assessment. The secondary endpoints will be meanreduction in facial fine lines, wrinkles and elasticity as assessed by VISIA CRand Cutometer, mean change in skin quality as assessed by Skin texture,firmness & elasticity scale (In use scales), validated Crows feet gradingscale and by self-assessment, mean increase in skin hydration as assessed byCorneometer and evaluation of safety through monitoring skin tolerance andoccurrence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Female adult subjects in general good health as determined from a recent medical history general physical examination, dermatological assessment.
- •2 Subjects in the age group of 35-50 years (both ages inclusive).
- •3 Subject with Fitzpatrick skin types III to V.
- •4 Subjects having visible fine lines and wrinkles in periorbital area (Crows feet under eye) and forehead 5 Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •6 Subject who agrees not to use any other product/treatment/home remedy except the provided dove soap bar on their face during the study period other than the test product.
- •7 Subjects who agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •8 Subjects who agree not to expose to excessive sun light.
- •(Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- •9 Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.
- •10 Subjects willing to abide by and comply with the study protocol.
排除标准
- •1 Subject with any other signs of significant local irritation or skin disease.
- •2 Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
- •3 Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- •4 Subjects who do not agree to remove all jewellery on/around face (e.g. necklace,earrings,if possible nose ring),during VISIA imaging.
- •5 Subjects having hairstyle which covers almost the entire forehead.
- •8 Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
- •9 Pregnant women (as confirmed by UPT) and lactating women.
- •10 Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
- •11 Subjects with skin allergy history or atopic dermatitis or psoriasis 12 Subjects who have participated in any other clinical trial in the last 3 months.
- •13 Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study 14 Subjects that was treated with botox/filler /biostimulatory molecules injection.
结局指标
主要结局
1 Mean reduction in facial fine line, wrinkles and elasticity as assessed by Antera & Dermatological visual assessment
时间窗: 1 Mean reduction in facial fine line, wrinkles and elasticity as assessed by Antera & Dermatological visual assessment (Screening, Baseline, Day 28 and Day 56)
次要结局
- 1 Mean reduction in facial fine line; wrinkles and elasticity - VISIA CR; Cutometer(2 Mean change in skin quality as assessed by Skin texture, firmness & elasticity scale (In use scales); validated Crows feet grading scale & by Self assessment.)