A Randomized, Double blinded, Comparative study to evaluate the efficacy of dermal irritancy potential of detergents in healthy human volunteers.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Comparison of Skin reaction scores (dryness and scales) between comparator and test products.
研究概览
简要总结
After obtaining the Ethics committee and CTRI approval subjects will be asked to visit the site. In visit 1 subjects are advised not to use any type of moisturizer during the course of the study. Also the subjects will be given a soap for their regular use for our study which should be used for 14 days. Then the Informed consent will be provided to the study volunteers, and after obtaining their consent, the female subjects will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. On 7th day, that is considered as day 0, the subjects are asked to visit the site for skin stripping and skin swabbing test. Then from day1 to day 3 subjects are asked to visit the site regularly for the study purpose. They are asked to wash their hands thoroughly with normal water, dry it and wait for 1 hour. After 1 hour, the instrumental analysis like Videoscopy, TEWL and Hydration will be done. After organizing the seating arrangements of volunteers for hand immersion in a convenient/comfortable manner, 50 percent of the volunteers in a test immerse their left hand in the sample coded as ‘A’ and right hand in the sample coded as ‘B’, the other 50 percent, vice versa. Each volunteer immerses his/her respective hand up to the wrist in the solution with constant movement of the fingers for agitating the liquid for 10 minutes. After each immersion, the volunteers wash the hands thoroughly with normal water and gently wipe with a lint Free tissue paper. After 1 hour, the efficacy assessments like Videoscopy, TEWL, Hydration and dermatological assessments will be conducted. On Day 4 and day 7 subjects are asked to visit the site. Only dermatological Assessments, instrumental Assessments, skin swabbing and skin stripping will be done.
Day - 6: Study schedule explanation to the subjects, based on inclusion and exclusion criteria, subjects enrolled after taking informed consent form.
Day 0: Skin swabbing and skin Stripping
Day 1 – Dermatological and Instrumental assessments before and after Hand immersion
Day 2 – Dermatological and Instrumental assessments before and after Hand immersion
Day 3 – Dermatological and Instrumental assessments before and after Hand immersion
Day 4 - Dermatological, Instrumental assessments, skin swabbing and skin stripping
Day 7 – Dermatological, Instrumental assessments, skin swabbing and skin stripping
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult Female volunteers between 18 and 45 years.
- •Photo type II to V (which includes sensitive skin type)
- •Having apparently healthy skin on test area.
- •No H/O any allergies to any food/ food ingredients.
- •For whom the investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna…), during the course of the study.
- •Should avoid using any type of moisturizing cream or soaps or oil or face wash during the study (14days).
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnant/nursing mothers
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •Any allergies to any food/ food ingredients
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •Using any type of Moisturizing cream or soaps or face wash or oil.
- •Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
1. Comparison of Skin reaction scores (dryness and scales) between comparator and test products.
时间窗: Day 0 to Day 7
2. Comparison of Videoscopy between comparator and test products.
时间窗: Day 0 to Day 7
3. Comparison of TEWL between comparator and test products.
时间窗: Day 0 to Day 7
4. Comparison of Hydration level between comparator and test products.
时间窗: Day 0 to Day 7
次要结局
- Incidence & rate of adverse events(Day 0 to Day 7)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt. Ltd