Patch test to study the irritation potential of the study product.

Not Applicable

Registration Number: CTRI/2020/01/023041

Lead Sponsor: Sami Labs Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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.