To evaluate the efficacy of the cream formulation in reducing skin wrinkles, increasing skin firmness, smoothness and hydration.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of the anti ageing cream in reducing skin wrinkles, hyperpigmentation and increasing skin firmness, smoothness and hydration n repetitive usage on healthy human subjects
研究概览
简要总结
Study was designed to test the safety & efficacy of topical antiageing product provided by Dabur India Limited on healthy human subjects. 35 subjects (17 male & 18 female) were enrolled in the study, and 32 subjects ( 14 male & 18 female) completed the study. The study was conducted over a period of approximately 84 days for each subject. the evaluation was done by dermatologist , subject evaluation and by instrument (cutometer, visiometer, corneometer, visioscan, mexameter, chromameter).
The product need to use on daily twice on clean face and observation taken by subject, dermatologist & instrument at all the visits.
The results of the study showed that the formulation has the antiageing potential, the product improves the skin elasticity , firmness and reduce the wrinkles on face and the test product was also found to be safe in all the subjects during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.subjects in generally good health 2.Subjects in the age group of 30-50 years.
- •3.Subjects should have minimum number of fine lines, mild to moderate.
- •4.Subjects having a wrinkle and five volunteers with deep wrinkles will be selected for visiometer.
- •5.Must have at least 2 hyperpigmentation lesions (freckles, lentigen, periorbital melanosis) each at least 3mm on the face.
- •Subjects who exhibit moderate hyperpigmentation with a score of 3 but no greater than 4 (see scale in section 7.3.D.1).
- •6.Subject has not participated in a similar investigation in the past four weeks.
- •7.Subjects have not used a similar product for the last four weeks.
- •8.Subjects willing to give a written informed consent and come for regular follow.
排除标准
- •1.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, hydroquinone, vitamin C, Niacin amide, retinol, soy etc.
- •2.Currently or has been using topical retinoids, alpha-hydroxy and/or beta-hydroxy acids, hydroquinone or any whitening/Fairness preparation in any form (cleanser, toner, facial lotion, cream or soaps) within the last 1 month.
- •Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
- •4.Currently or has been involved in another facial skin care clinical investigation within the last 3 months.
- •5.Subjects who have pre-existing or dormant facial dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator.
- •6.Subjects with excessive facial hair or scars (including acne scars), which could interfere with expert grader and/or instrumental evaluations.
- •7.Subjects having melasma and severe photo damage.
- •8.Subjects who are nursing as determined by the investigator interview during screening or pregnant as determined by the Urine pregnancy testing after screening.
- •9.Subjects viewed by the investigator as not being able to complete the study.
结局指标
主要结局
To evaluate the efficacy of the anti ageing cream in reducing skin wrinkles, hyperpigmentation and increasing skin firmness, smoothness and hydration n repetitive usage on healthy human subjects
时间窗: Day 1, Day 2, Week 2, Week 4, Week 8 and Week 12
次要结局
- Safety of the subject throughout the study(Day 1, Day 2, Week 2, Week 4, Week 8 and Week 12)