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To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants

Skin Care Clinical Trial

Official title:
A Clinical Study to Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Subjects

Clinical Trial Summary

To evaluate the skin irritation and sensitization potential of a cosmetic facial product, under exaggerated conditions of use with controlled product application and under supervision of a dermatologist.

Clinical Trial Description

In this three-phase phototoxicity-photosensitisation (PT-PA) study, the test material and a positive control are applied under a semi-occlusive patch to the upper back of each subject. The first phase of the study is an Induction Phase; a controlled amount of each product is applied under a semi-occlusive patch. The patch will remain on the skin for 24 (±2) hours during this phase. Following patch removal the patch site will be exposed to ultraviolet - A (UVA) radiation and re-assessed 24 hours later prior to re-application of another semi-occlusive patch (with both the products) to the same site. The Induction phase will last 3 weeks. After a subject completes the Induction Phase they will enter a Rest Phase of 2 weeks duration, during which no patches will be applied. After the Rest Phase, subjects will return to the clinical site for the Challenge Phase. In the Challenge phase two test patches will be applied to virgin skin areas on each subjects' upper back for 24 hours. Following removal of both patches, one of the Challenge patch test sites will be exposed to UVA radiation. Both Challenge patch test sites will be assessed up until 72 (±2) hours later. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03183518
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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