Test the Phototoxicity of Sunscreen Products

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

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.

Study Overview

• Status: Completed
• Conditions: Sunscreen Agents
• Intervention / Treatment: Drug: SPF 50 Y65 110 (BAY987519); Drug: SPF 50 Y51 002 (BAY987519); Drug: SPF 15 V27 104 (BAY987519); Drug: Sodium chloride [NaCl]

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pinellas Park, Florida, United States, 33781

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects, aged 18 to 65 years
• Good general health, as assessed by medical history and brief visual examination of the skin
• Fitzpatrick skin Type I IV, determined by interview at screening
• Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
• Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
• Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104; All test products (SPF 50 Y65 110,SPF 50 Y51 002, and SPF 15 V27 l 04 compared to that of a negative control [0.9% NaCl]) were tested simultaneously on each subject.

Drug: SPF 50 Y65 110 (BAY987519); Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.; Drug: SPF 50 Y51 002 (BAY987519); Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.; Drug: SPF 15 V27 104 (BAY987519); Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.; Drug: Sodium chloride [NaCl]; Negative control (200 µL, 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin irritation	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	up to 1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse event as a measure of safety and tolerability	up to 1 week

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2015
• Primary Completion (Actual): April 26, 2015
• Study Completion (Actual): April 26, 2015

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Phototoxic
• Other Study ID Numbers: 18287

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No