CTRI/2024/06/069652
Not yet recruiting
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kayura Effect LLP
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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