To Test for Photo Allergy Reaction of Sunscreens

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

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.

Study Overview

• Status: Completed
• Conditions: Photoallergy
• 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): 56
• 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women, aged 18 to 65 with good general health
• Fitzpatrick skin type I IV
• Females (of childbearing potential) on acceptable measure of contraception
• Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
• Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. 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 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
Evaluation of inflammatory responses	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)	up to 3 weeks
Evaluation of superficial effects	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	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse event collection as a measure of safety and tolerability	up to 3 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2015
• Primary Completion (Actual): May 8, 2015
• Study Completion (Actual): May 8, 2015

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 19, 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; Immune System Diseases; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Allergic Contact; Dermatitis, Photoallergic
• Other Study ID Numbers: 18291

Drug and device information, study documents

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