CTRI/2022/12/048355
Completed
未知
Evaluation of Skin Safety of a test product using 24 Hours Patch Test Under CompleteOcclusion on Adult Healthy Human Participants with Sensitive Skin. IS 4011:2018 Guidelines.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dabur India Limited
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Voluntary men and women (preferably equal number of males and females) between 18
- •and 65 years having sensitive skin in nasolabial area as determined by lactic acid sting
- •b) Fitzpatrick skin type III to IV.
- •c) Having apparently healthy skin on test area.
- •d) Willingness to discontinue the use of cleansing and/or cosmetic products in the application
- •areas during the course of the trial.
- •e) Cooperating, informed of the need and duration of the examinations, and ready to comply
- •with protocol procedures.
- •f) Willing to give written informed consent to participate in the trial after informing all
- •information concerning the trial procedures and trial objectives.
Exclusion Criteria
- •a) Pregnancy (by UPT) and lactating women.
- •b) Scars, excessive terminal hair, tattoo, cuts, wounds, irritation symptoms, abrasion, or any
- •other skin condition on the studied area.
- •c) Athletes and subjects with history of excessive sweating.
- •d) Subjects on oral corticosteroid.
- •e) Any history of underlying uncontrolled medical illness including diabetes, liver disease or
- •history of alcoholism, HIV, or any other serious medical illness.
- •f) A participant who the Investigator feels will not be compliant with trial requirements
- •g) Dermatological infection/pathology on the level of studied area.
- •h) Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
Outcomes
Primary Outcomes
Not specified
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