CTRI/2026/01/101703尚未招募不适用
A clinical study to Evaluate the skin sensitization potential of Apex Firztbar- Bathing Bar on Healthy Human volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
研究概览
简要总结
210 human volunteers are selected for the patch test done as per ISO 10993 Part23 for sensitization
The experiment is 40 days including Induction phase: 21 days Rest Phase: 14 days Challenge Phase: 5 days.
Guideline Followed: ISO10993 Part 23: for skin sensitization
1. Firztbar- Bathing Bar
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary man or women between 18 and 65 years.
- •Phototype III to V.
- •Having apparently healthy skin on test area.
- •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 be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.Chronic illness which may influence the outcome of the study 8.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) 9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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