CTRI/2023/05/053321进行中(未招募)4 期
Evaluation of Skin Safety of test product using 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Participants with Non-Sensitive Skin
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Voluntary men and women ratio of 1:1 between 18 and 65 year
- •2.Having healthy skin on test area as assessed by
- •dermatological examination
- •3.For whom the investigator considers that the compliance will be correct
- •4. Subjects with normal, dry, oily and combination skin in approximately equal ratio.
- •5. Subjects cooperating informed of the need and duration of the examination and ready to comply
- •with protocol procedures.
- •6. Having a signed consent form.
- •7. Subjects’ willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study.
- •8. Willingness to avoid excessive water contact (for example swimming) or activity which causes
- •excessive sweating (that is exercise, sauna ….), during the study.
- •9. Having valid proof of identity and age.
- •10. Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).
排除标准
- •1.Pregnant/nursing mothers.
- •2.Scars, excessive terminal hair, or tattoo on the studied area.
- •3.Dermatological infection/pathology on level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
- •5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •6.Chronic illness which may influence the outcome of the study.
- •7.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).
- •8.Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.
研究者
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