Clinical Trial: Test the Phototoxicity of Sunscreen Products

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Study to Assess the Potential for Phototoxicity of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27-104 in Human Subjects

Brief Summary:

The primary objective of this study was to evaluate the potential for phototoxicity of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

The secondary objective of this study was to evaluate the safety of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring adverse events (AEs) throughout the study.


Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Skin irritation [ Time Frame: up to 1 week ]

Skin irritation was rated on a scale from 0-7 where 0 is no evidence of irritation and 7 is strong reaction spreading beyond test site


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of adverse event as a measure of safety and tolerability [ Time Frame: up to 1 week ]

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: June 14, 2016
Date Started: April 2015
Date Completion:
Last Updated: June 14, 2016
Last Verified: June 2016