CTRI/2011/06/001778已完成未知
Evaluation of the safety of 1 test product for phototoxicity, using a photo patch test technique
AMRA Remedies0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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/or women.
- •2. Between 18 and 65 years.
- •3. Photo type III and IV.
- •4. Having apparently healthy skin on test area.
- •5. Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
- •6. For whom the investigator considers that the compliance will be correct.
- •7. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •8. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
- •9. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study except as required for study protocol.
- •10. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna?), during the course of the study.
- •11. Ready to wear loose cotton clothes.
排除标准
- •1. People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking, exercising etc).
- •2. Pregnant women and lactating women.
- •Scars, excessive terminal hair or tattoo on the studied area.
- •3. Dermatological infection/pathology on the level of studied area.
- •4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, UV light or sunlight).
- •5. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •6. 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).
- •7. Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
研究者
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