CTRI/2024/06/069652尚未招募Unknown
Evaluation of dermatological safety of test products by 24 hours patch test under complete occlusion, semi occlusion, open patch on adult healthy human subjects. - NI
Kayura Effect LLP0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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) Age: 18-65 years (both inclusive) at the time of consent.
- •2)Sex: Males and non-pregnant/non-lactating females (preferably an
- •equal number of males and females).
- •3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination
- •4) 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.
- •6)Subject is in good general health as determined by the Investigator on the basis of medical history.
- •7) Subjects is willing to maintain the test patches in designated positions for 24 Hours.
- •8) Subject is willing and able to follow the study directions, to
- •participate in the study, returning for all specified visits.
- •9)Subject must be able to understand and provide written informed
- •consent to participate in the study.
- •10) Subject is willing to refrain from vigorous physical exercise during the study period and
- •follow all the instruction given.
排除标准
- •1) 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.
- •2) Medication which may affect skin response and/or past medical
- •3) 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.
- •5) Subject suffering from any active clinically significant skin
- •diseases which may contraindicate.
- •6) Subject having history of any skin diseases including eczema,
- •atopic dermatitis or active cancer.
- •7) Participation in any patch test for irritation or sensitization within
- •the last four weeks.
- •8) Subject having history of asthma or COPD (Chronic obstructive
- •pulmonary disease).
- •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 product application (steroidal nose drops and/or eye
- •drops are permitted)
研究者
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