A study to evaluate the efficacy of test products in providing skin benefits like moisturization, anti-aging, exfoliation and brightening benefits among healthy female participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- 1) the deep moisturization benefit between groups as well as against the baseline,using dermatological and instrumental assessments.
研究概览
简要总结
The study is designed to evaluate the efficacy of test products in providing skin benefits like moisturization, anti-aging, exfoliation and brightening benefits among healthy female participants in comparison with the placebo and the baseline.
The participants who satisfy the inclusion-exclusion criteria will be enrolled after obtaining the informed consent form. 33 female participants in good general health, aged 35 to 60 years, will be screened and enrolled in the study.
Participants will be asked to report for the assessment visit in the morning and should have taken a bath before coming for the assessments and without any product application in their face in the past 12-16 hours.
The compliance will be checked by non-leading questions and visual assessment of the test area.
The participants will be asked to wash their face with a neutral face wash and pat dry with paper towels. The participants will then acclimatize under a standard atmospheric condition for 15± 5 minutes prior to the baseline measurements by using dermatological and instrumental assessments. Similar assessements will be performed during the following visits throughout the study duration to determine the safety and efficacy of the test products in providing skin benefits like moisturisation, antiageing, exfoliation and skin brightening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy female subjects, as determined from a recent medical history.
- •Subjects in the age group of 35-60 years (both ages inclusive)
- •Subjects with all skin types (preferably in equal ratio).
- •Subjects with dull-looking skin.
- •Subjects who have not used retinol-based products minimum 8 weeks prior to enrollment (only for group 2).
- •Subjects with fine lines around the eyes (only for group 2)
- •Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •Subjects who agree not to use any other product/treatment/home remedy/soap bar on their face during the study period other than the test products.
- •Subjects must not be using any other skin-brightening products, or topical treatments during the study period (mandatory for group 4).
- •Subjects who agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •(Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- •Subjects willing to give voluntary written informed consent and agree to come for regular follow-up.
排除标准
- •A known history or present condition of an allergic response to any cosmetic products.
- •Subject having active skin diseases (e.g., active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the assessment.
- •Subjects who have sensitivity towards products containing AHA/BHA or Vit C or Retinol components.
- •Subjects had cancer in the last 10 years
- •Subjects with wounds, sunburn, scars, tattoos or piercings at the skin test site(s)
- •Subjects with application of ointments, creams etc.
- •for antibacterial, anti-allergic or immunosuppressive treatment of the skin at the test site(s)
- •History of intense sun exposure and/ photo toxicity/allergy.
- •Female subjects who are pregnant, lactating or nursing.
- •Chronic illness which may influence the cutaneous state.
- •Subject participating in any other cosmetic or therapeutic trial.
- •Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
结局指标
主要结局
1) the deep moisturization benefit between groups as well as against the baseline,using dermatological and instrumental assessments.
时间窗: baseline, weeks 1,2,4 and 8
2) the antiaging benefit between groups as well as against the baseline,using dermatological and instrumental assessments.
时间窗: baseline, weeks 1,2,4 and 8
3) the exfoliation benefits between groups as well as against the baseline,using dermatological and instrumental assessments.
时间窗: baseline, weeks 1,2,4 and 8
4) the brightening effect between groups as well as against the baseline,using dermatological and instrumental assessments.
时间窗: baseline, weeks 1,2,4 and 8
次要结局
- the efficacy of test products using subject self-assessment.(8 weeks)
研究者
Dr Mukta Sachdev
MS Clinical research