CTRI/2025/06/088536尚未招募不适用
A Clinical Study to Evaluate the Skin Sensitization potential of Brainbees Babyhug Pro Sensitive pH 5.5 Peach Milk Baby Wipes on Healthy Human Volunteers
Brainbees Solutions Ltd1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年6月16日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in Skin Irritation Score-erythema & oedema
研究概览
简要总结
210 human volunteers are selected for the patch test done as per BIS 4011 for sensitization
The experiment is 40 days including Induction phase: 21 days Rest Phase: 14 days Challenge Phase: 5 days.
Guideline Followed: BIS 4011: for skin sensitization
- Brainbees Babyhug Pro Sensitive pH 5.5 Peach Milk Baby Wipes
**Estimated time in study completion:**90-100 days.
· Screening Phase
· Induction Phase (21 DAYS) (24 hours after each patch removal)
· Rest Phase (14 DAYS)
Challenge Phase(5 days) (24 hours after the patch removal, 48 hours after patch removal and 72 hours after the patch removal)
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
- 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.
结局指标
主要结局
Change in Skin Irritation Score-erythema & oedema
时间窗: D2, D4, D6, D9, D11, D13, D16, D18, D20, D23,D24, D25
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (1)
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