Safety evaluation of test products on healthy human skin types

Phase 4

Completed

• Conditions: Healthy Human

• Registration Number: CTRI/2023/03/050684
• Lead Sponsor: KK organic

Brief Summary

Irritants are substances that provoke immediate response in the skin perceived as a superficial skin reaction in terms of erythema, oedema and/or papules. The severity of irritation depends upon the nature, concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), and vesiculation and finally, to an intense supportive reaction without the involvement of the immune system. In this patch test the irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-19
• Study Completion: 2023-03-23
• Last Update Posted: 2023-06-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1.Voluntary men and women ration of 1:1 between 18 and 65 years.
• 2.Having healthy skin on test area as assessed by dermatological examination.
• 3.For whom the investigator considers that the compliance will be correct.
• 4.Subjects with normal, dry, oily and combination skin.

Exclusion Criteria

• 1.Pregnant/nursing mothers.
• 2.Scars, excessive terminal hair, or tattoo on the studied area.
• 3.Dermatological infection/pathology on level of studied area.
• 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects that showed No significant irritation.	Day 1, Day 2, Day 3, Day 8
Score of less than or equal to 2 on the Draize scale.	Day 1, Day 2, Day 3, Day 8

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

TrialGuna Private Limited; 🇮🇳 Bangalore, KARNATAKA, India

TrialGuna Private Limited

🇮🇳Bangalore, KARNATAKA, India

Dr Sohandas Shetty

Principal investigator

8867125414

drsohanshetty@yahoo.co.in