CTRI/2023/07/055614
Completed
Phase 3
A Randomized, Double blinded, Comparative study to evaluate theefficacy of dermal irritancy potential of detergents in healthy humanvolunteers. - NI
nilever Industries Private Limited0 sites24 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- nilever Industries Private Limited
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult volunteers between 18 and 45 years.
- •2\.Photo type II to V (which includes sensitive skin type)
- •3\.Having apparently healthy skin on test area.
- •4\.No H O any allergies to any food/ food ingredients.
- •5\.For whom the investigator considers that the compliance will be correct.
- •6\.Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •7\.Having signed a Consent Form.
- •8\.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •9\.Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna…), during the course of the study.
- •10\.hould avoid using any type of moisturizing cream or soaps or face wash during the study (14days).
Exclusion Criteria
- •1\.Pregnant/nursing mothers
- •2\.Scars, excessive terminal hair or tattoo on the studied area.
- •3\.Dermatological infection/pathology on the level of studied area.
- •4\.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •5\.Any allergies to any food/ food ingredients
- •6\.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •7\.Chronic illness which may influence the outcome of the study.
- •8\.Using any type of Moisturizing cream or soaps or face wash.
- •9\.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •10\.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Not specified
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