CTRI/2020/01/023041
Not yet recruiting
未知
Skin Irritation Test (Patch Test in Humans) (IS 4011:2018)
Sami Labs Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sami Labs Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 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 test.
- •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 water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study.
- •9 Should be able to read and write (in English, Hindi or local language).
- •10 Having any valid proof of identity and age.
Exclusion Criteria
- •1 Pregnancy (by history) and lactating women.
- •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/pathology on the level of studied area.
- •5 Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
- •6 Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •7 Chronic illness which may influence the outcome of the study.
- •8 Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month).
- •9 Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Not specified
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