NCT03183518

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Skin Care

Interventions

Type	Name	Description
OTHER	Facial micellar cleanser	Each participant will have the test product applied topically via semi occlusive patch, on-site by a technician.
OTHER	Saline Solution: Sodium Chloride (NaCl; 0.9%)	Each participant will have the reference product applied topically via semi occlusive patch, on-site by a technician.

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2017-06-12
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

1 site across 1 country: Brazil