CTRI/2023/01/048802
Completed
未知
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on Adult Healthy Human Participants.
nilever Industries Pvt Ltd0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- nilever Industries Pvt Ltd
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants in age group 18 \- 65 years (both the ages inclusive).
- •2\. Healthy male \& female participants with skin types as defined in the population.
- •3\. Participants in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •4\. Participants of any skin type providing the skin pigmentation will allow discernment of erythema
- •5\. Participants able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •6\. Participants willing to give a voluntary written informed consent.
- •7\. Participants willing to maintain the patch in position for 24 hours.
- •8\. Participants having not participated in a similar investigation in the past two weeks.
- •9\. Participants willing to come for regular follow up visits.
- •10\. Participants ready to follow instructions during the study period.
Exclusion Criteria
- •1\. Participants with infection, allergy, psoriasis and/or active atopic dermatitis/eczema on the tested area.
- •2\. Athletes and participants with history of excessive sweating.
- •3\. Participants with cutaneous disease which may influence the study result.
- •4\. Participants on oral corticosteroid.
- •5\. Participants participating in any other cosmetic or therapeutic trial or have participated in a similar investigation in the past two weeks.
- •6\. Participants who are currently pregnant or lactating or planning to become pregnant in the period of study.
- •7\. Participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •8\. More than one participant selected/participating from one family/household.
- •9\. Participants working with MSCR
Outcomes
Primary Outcomes
Not specified
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