Clinical Trial: To Test for Photo Allergy Reaction of Sunscreens

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

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

Brief Summary:

The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.

The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

• Evaluation of inflammatory responses [ Time Frame: up to 3 weeks ]
  Inflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)
• Evaluation of superficial effects [ Time Frame: up to 3 weeks ]
  Superficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skin

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse event collection as a measure of safety and tolerability [ Time Frame: up to 3 weeks ]

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: June 14, 2016
Date Started: March 2015
Date Completion:
Last Updated: August 17, 2016
Last Verified: August 2016