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To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants

Skin Care Clinical Trial

Official title:
A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product

Clinical Trial Summary

The objective of this clinical study is to assess the irritation and sensitisation potential of a cosmetic test product after repeated semi-occlusive patch applications to healthy human participants by following a conventional HRIPT methodology under supervision of a dermatologist.

Clinical Trial Description

The first phase of the study is an Induction Phase; a known amount of each product (test and control) is applied, under a semi-occlusive patch. Patches will remain on the skin for 48 (±2) (weekdays) or 72 (±2) (including inclusive weekends) hours during this phase. Induction phase lasts for 3 weeks. After the Induction Phase participants will enter a Rest Phase of 2 weeks duration, during which no patches are applied. After the Rest Phase, participants will return to the clinical site for the Challenge Phase. In this phase a challenge patch containing the test and control products is applied to virgin skin for 48 (±2) hours then assessed 30 minutes (maximum 1 hour) following removal, 24 (± 2) and 48 (±2) hours later. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03175562
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase N/A
Start date March 27, 2017
Completion date May 19, 2017
View Details
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