CTRI/2024/03/064349已完成未知
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Sensitive Skin. - NI
Honasa Consumer Ltd.0 个研究点目标入组 25 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
- 25
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)Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
- •2)Participants with normal Fitzpatrick skin type III to V. (Human skin colour determination scale).
- •3)Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •4)Participants scoring greater than 30 for Section 2- Sensitive versus Resistant skin in modified Dr. Baumann’s skin type questionnaire.
- •5)Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
- •6)Participants are in good general health as determined by the Investigator on the basis of medical history.
- •7)Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
- •8)Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
- •9)Participants must be able to understand and provide written informed consent to participate in the study.
- •10)Participants having valid proof of identity and age
排除标准
- •1)Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos, 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.
- •2)Participant with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •3)Participant suffering from any active clinically significant skin diseases which
- •may affect the study results.
- •4)Participant having history of any skin diseases including eczema, atopic dermatitis.
- •5)Participation in any patch test for irritation or sensitization within the last four weeks. Participation in other patch study simultaneously.
- •6)Participants with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
- •7)Participants with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the Participant ineligible or places the Participant at undue risk.
- •8)Participant with known allergy or sensitization to medical adhesives, bandages.
- •9)Use of any:
- •i.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •ii.Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •iii.Systemic or topical corticosteroids at patch site within four (4) weeks of test article application (steroidal nose drops and/or eye drops are permitted)
- •iv.Topical drugs used at application site
研究者
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