Evaluation of Skin Safety of a test product Minoxidil 10%w/v and Finasteride 0.1%w/vTopical Solution for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.
研究概览
简要总结
The Patch test is performed to assess the dermal safety of test product involved in the study. It is a technique used to determine the potential of specific substances to cause irritancy of the skin.
In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed and the marked site is scored post 24 hours after the removal of the patches. Reactions such as erythema, dryness and wrinkling are scored on a 0– 4-point scale and oedema is scored on another 0 – 4-point scale (Draize scale).
52 Healthy Men and Women will be included in this study and the irritancy of the test product will be assessed.
Result: The study was completed with 52 complete cases and no adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Voluntary men and women between 18 and 60 years.
- •2.Photo type III to V.
- •Having apparently healthy skin on test area.
- •3.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.
- •5.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 water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the study.
- •8 Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnancy (by history) and lactating women.
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Dermatological infection/pathology on the level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •5.Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •Chronic illness which may influence the outcome of the study.
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month).
- •Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.
时间窗: Induction Phase: | - Patch application on Visit V1, V3, V5, V7, V9, V11, V13, V15 and V17. | - Patch removal on Visit 2 (V2, V4, V6, V8, V10, V12, V14, V16 and V18). | - Scoring on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) | Rest Phase: 10 – 14 days | Challenge Phase: Patch application will be on naïve sites on the arm/back on V20; patch will be removed at V21 (24 hours). Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours).
次要结局
未报告次要终点