Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion/Semi Occlusion/Open Patch on Adult Healthy Human Subjects.

Novamed Laboratories Pvt. Ltd.1 个研究点分布在 1 个国家目标入组 26 人开始时间: 2025年11月7日最近更新: 2025年6月20日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 26
试验地点: 1
主要终点: test

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is single-centre, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under inclusion | semi occlusion | open patch for at least 24 hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. there are total three visits in this study and are optional visit pre-screening visit: Lactic Acid Stinging test & Modified Dr baumenn’s skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Age: 18-65 years (both inclusive) at the time of consent.
•Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
•Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
•Females of childbearing potential must have a self-reported negative pregnancy test 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
•Subject is in good general health as determined by the Investigator on the basis of medical history.
•Subjects is willing to maintain the test patches in designated positions for 24 Hours.
•Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
•Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
•For Sensitive Specific Skin Study Only: • Subject scoring greater than 30 for Section 2 – Sensitive v/s Resistant skin in modified Dr Baumann’s skin type questionnaire.
•• Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.

排除标准

•Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
•Medication which may affect skin response and/or past medical history.
•Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
•Subject suffering from any active clinically significant skin diseases which may contraindicate.
•Participation in any patch test for irritation or sensitization within the last four weeks.