To evaluate the safety of Primary Irritation Patch Test test product in healthy volunteers

Phase 4

Completed

• Conditions: Healthy Human Volunteers

• Registration Number: CTRI/2022/12/048219
• Lead Sponsor: Vasu Health Care

Brief Summary

The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. A primary irritation patch test is used widely for the evaluation of the safety of cosmetics in humans. Sample Size: Twenty-four (male and female, in a nearly equal ratio of 1:1) adult subjects in the age group of 35 years to 65 years (both inclusive) Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance. By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs. and is done as per BIS standard (BIS4011:2018).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Study Completion: 2023-01-27
• Last Update Posted: 2023-09-03

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
• 2.Healthy Men & women volunteers are chosen in ratio of 1:1 aged > 35 and < 60 years.
• 3.Having healthy skin on test area as assessed by dermatological examination and don’t have history of allergy.

Exclusion Criteria

• 1.Pregnant/nursing mothers.
• 2.Scars, excessive terminal hair, or tattoos on the studied area.
• 3.Dermatological infection/pathology on level of studied area.
• 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Chronic illness which may influence the outcome of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.1. Primary End Point: Number ofsubjects that showed no significant irritation. Score of less than or equal to 2 on the Draize scale.	Baseline,Day1, Day 2, Day 3, Day 7

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

TrialGuna; 🇮🇳 Bangalore, KARNATAKA, India

TrialGuna

🇮🇳Bangalore, KARNATAKA, India

Ashwini N J

Principal investigator

6361137954

ashwini.nj@trialguna.com