To evaluate the efficacy of hair removing cream formulations for hair.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of hair removing cream and skin darkening effect on Repetitive usage on healthy human subjects
研究概览
简要总结
Study was designed to test the safety & efficacy of topical products provided by Dabur India Limited on healthy human subjects. 24 female subjects were enrolled in the study, and 23 completed the study. The study was conducted over a period of approximately 60 days for each subject. the test product was patched on the arms of the subject . The skin was evaluated for signs of irritation identified under Erythema and odema, using Draize’s scale.
After patch removal, the sample test product applied on skin was applied for 3-6 minutes and observation taken by dermatologist, self subject observation and instrument test on corneometer, hair analyzer , Mexameter and chromometer . Post product removal, observation taken for immediate reactions and 30 days & 60 days post removal for delayed reactions.
All the test products were deemed to be dermatologically safe as per their classification into non irritant category at all time points of evaluation. The hair was removed within the time range of 3-6 minutes by test products and skin fairness, glow improves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Subjects in generally good health 2.Subjects in the age group of 18-35 years.
- •3.Subjects with moderate hair growth on lower outer forearms.
- •4.Subjects without any cuts, marks and open wounds on lower outer forearms.
- •5.Subject has not participated in a similar investigation in the past four weeks.
- •6.Subjects have not used a similar product for the last four weeks.
- •7.Subjects willing to give a written informed consent and come for regular follow up.
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, cream or soaps) within the last 1 month.
- •3.Currently or has been undergoing dermatologist skin treatments or procedures within the last 1 month.
- •4.Currently or has been involved in another skin care clinical investigation within the last 3 months.
- •5.Subjects who have pre-existing or dormant 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 scars which could interfere with expert grader and/or instrumental evaluations.
- •7.Subjects who are nursing as determined by the investigator interview during screening or pregnant as determined by the Urine pregnancy testing after screening.
- •8.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 hair removing cream and skin darkening effect on Repetitive usage on healthy human subjects
时间窗: Day 1, Day 30 and Day 60
次要结局
- safety of the subject throughout the study(Day 1, Day 30 and Day 60)