CTRI/2024/05/067210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 Ltd0 个研究点目标入组 26 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
- 26
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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