CTRI/2024/07/070419
Not yet recruiting
未知
A clinical Study to evaluate the skin irritation potential of FARE Labs Baby Lotion (DBM-003) on healthy human subjects - NI
FARE Labs Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FARE Labs Private Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Voluntary man or women between 18 and 65 years.
- •2\. Photo type III to V.
- •3\. Having apparently healthy skin on test area
- •4\. For whom the investigator considers that the compliance will be correct.
- •5\. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •6\. Having signed a Consent Form.
- •7\. Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
- •8\. 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.
- •9\. Should be able to read and write (in English, Hindi or local language).
- •10\. Having valid proof of identity and age.
Exclusion Criteria
- •1\. Pregnant or nursing mothers
- •2\.Scars, excessive terminal hair or tattoo on the studied area
- •3\.Henna tattoo anywhere on the body (in case of studies involving hair dyes)
- •4\.Dermatological infection or pathology on the level of studied area
- •5\.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
- •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\.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)
- •9\.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Not specified
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