EVALUATION OF THE EFFICACY AND TOLERANCE OF A SKIN ANTI AGEING TEST PRODUCT IN WOMEN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The Primary Evaluation criteria (Primary Objective) for this study:
研究概览
简要总结
· It is a test under dermatological control, monocentric, controlled, comparative versus initial state and Placebo.
· On Day 0: Test site will be cleaned with water and volunteers will be acclimatized for 1 hour.
· Clinical Evaluation using skin age score by Expert, MoistureMeter SC measurements and Cutometer measurements will be carried out on all volunteers at all visits on Day 0, Day 15 and Day 30.
· PRIMOS evaluation of wrinkles in crow’s feet area will be carried out on Day 0 and Day 30.
· Self-Evaluation questionnaire will be evaluated at Day 15 and Day 30
· Follow up visits will be on Day 15 and Day 30.
· Digital photographs will be taken on Day 0, Day 15 and Day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Voluntary women with moderate wrinkles (not greater than 2- 3 fine lines extending upto lateral end of eyebrow, but not beyond).
- •2.Age Limit: 35 – 55 years.
- •3.Has been fully informed verbally and in writing and comply with the study specifications.
- •Signature for participation in test.
- •4.Photo type: III (White skin which sometimes burns, difficult to tan) and IV (Moderate brown skin which rarely burns and tans with ease).
- •5.Accepting not to use products with same end benefit, or containing sunscreen, during the study.
- •6.Co-operating, informed of the need and duration of the examinations.
- •7.For which the Investigator considers that the compliance will be correct.
排除标准
- •1.Skin allergy antecedents or atopic subject.
- •2.Pregnant women (as confirmed by UPT) and lactating women.
- •3.Seasonal allergies/Hyper sensitivity to any cosmetic product.
- •4.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedure.
- •5.Subjects on any medical treatment either systemic/topical in the past 1 month which may interfere with the performance of the study treatment.
- •6.Subject in an exclusion period or participating in any other similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
结局指标
主要结局
The Primary Evaluation criteria (Primary Objective) for this study:
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
•Measuring depth of wrinkles around crow’s feet area using PRIMOS
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
•Hydration of Stratum corneum by MoistureMeter SC
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
•Cutometer measurements for elasticity and firmness.
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
The Secondary Evaluation Criteria (Primary Objective) for this study:
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
•Self evaluation questionnaire to evaluate the product efficacy and sensorial properties.
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
•Clinical Evaluation using skin age score.
时间窗: The Primary Evaluation criteria (Primary Objective) : | •Measuring depth of wrinkles using PRIMOS on Day 0 and Day 30. | •Hydration by MoistureMeter SC on Day 0, 15 and 30. | •Cutometer measurements for elasticity and firmness on Day 0, 15 and 30. | The Secondary Evaluation Criteria (Primary Objective) : | •Self evaluation questionnaire to evaluate the product efficacy and sensorial properties on Day 15 and 30. | •Clinical Evaluation using skin age score on Day 0, 15 and 30.
次要结局
- •Clinical Evaluation for tolerance(Day 15 and Day 30)