Skin Irritation test on The Good Karma Co skin and personal care products

Recruiting

Brief Summary: **The below products would be tested as per the guideline IS405. 11 for dermal safety assessme****nt.**

**1. All Day Cream for Men- Cream**

**2. Hand and Foot Cream - Cream**

**3. Skin Renewal Cream - Cream**

**4. Body Cream with Lavender - Cream**

**5. Tea Tree Face Mist - Mist**

**6. Apple Cider Vinegar Face Toner - Toner**

**7. Under Eye Gel - Gel**

**8. Skin Brightening Gel - Gel**

**9. Pore Cleansing Gel - Gel**

**10. Coconut milk & Oatmeal Body Scrub- Scrub**

**11. Face Pack with Neem & Turmeric - Facepack**

**12. Body Lotion - Lotion**

**13. 10% Niacinamide Face Serum- Serum**

**14. Vitamin C Serum with Arbutin - Serum**

**15. Cleansing Make up Balm -**

**16. Blue Berry Night Gel - Gel**

**17. Intimate Wash for Women - Wash**

Recruitment & Eligibility

Inclusion Criteria

1.Voluntary man/women between 18 and 65 years.
Photo type III to V.
Having apparently healthy skin on test area 4.
For whom the investigator considers that the compliance will be correct.
Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
Having signed a Consent Form.
Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, saunaâ€¦), during the course of the study.
Should be able to read and write (in English, Hindi or local language).
Having valid proof of identity and age.

Exclusion Criteria

Pregnant/nursing mothers 2.
Scars, excessive terminal hair or tattoo on the studied area.
Henna tattoo anywhere on the body (in case of studies involving hair dyes).
Dermatological infection/pathology on the level of studied area.
Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
Chronic illness which may influence the outcome of the study.
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).
Subject in an exclusion period or participating in another food,cosmetic or therapeutic trial.

Primary Outcome Measures

Name	Time	Method
Change in Skin Irritation Score-erythema & oedema	Day 1,Day 2, Day 8

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Locations (1): CCFT laboratories
🇮🇳
Meerut, UTTAR PRADESH, India
CCFT laboratories
🇮🇳Meerut, UTTAR PRADESH, India
Dr Robin Chugh
Principal investigator
7078103723
robinderm25@gmail.com