CTRI/2020/06/025777尚未招募未知
Evaluation of skin sensitization potential ofinvestigational products by Human Repeat Insult Patch Test (HRIPT)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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. Male or female subjects 18 to 65 years of age.
- •2. Subjects must be generally in good health as
- •determined from a recent medical history which
- •is on file with the investigator.
- •3. The ability of the subject to understand and sign
- •a written informed consent form which must be
- •obtained prior to treatment.
- •4. Willingness to avoid UV exposure (sun or
- •artificial UV) on the test sites during the course of
- •5. Subjects must have clear back. They should not
- •have any infection or allergy on the tested area.
- •They should have healthy skin on test area
- •6. Subjects should be cooperative, informed of the
- •need and duration of the examination and ready
- •to comply with the protocol procedures
- •7. Subjects having valid proof of identity and age.
- •8. Willingness to avoid excessive water contact
- •(like swimming etc.) or activity which causes
- •excessive sweating (like exercise, sauna, etc.)
- •during the course of study
- •9. Subjects with skin photo type III to V
排除标准
- •1. Pregnant women/ Nursing mothers
- •2. Scars, excessive terminal hair, or tattoo on the studied area.
- •3. Dermatological infection/pathology
- •4. Hypersensitivity, allergy antecedent (to any
- •cosmetic product, raw material)
- •5. Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures
- •6. Chronic illness which may influence the outcome of the study.
- •7. Subject 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.
- •9. Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision
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