To Test for Photo Allergy Reaction of Sunscreens

Not Applicable

Completed

• Conditions: Photoallergy
• Interventions: Drug: SPF 50 Y65 110 (BAY987519); Drug: SPF 50 Y51 002 (BAY987519); Drug: SPF 15 V27 104 (BAY987519); Drug: Sodium chloride [NaCl]

• Registration Number: NCT02872220
• Lead Sponsor: Bayer

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 Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Primary Completion: 2015-05-08
• Study Completion: 2015-05-08
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-19
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	SPF 50 Y65 110 (BAY987519)	All test products compared to that of a negative control \[0.9% NaCl\] were tested simultaneously on each subject.
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	SPF 50 Y51 002 (BAY987519)	All test products compared to that of a negative control \[0.9% NaCl\] were tested simultaneously on each subject.
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	SPF 15 V27 104 (BAY987519)	All test products compared to that of a negative control \[0.9% NaCl\] were tested simultaneously on each subject.
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	Sodium chloride [NaCl]	All test products compared to that of a negative control \[0.9% NaCl\] were tested simultaneously on each subject.

Primary Outcome Measures

Name	Time	Method
Evaluation of inflammatory responses	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	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

Secondary Outcome Measures

Name	Time	Method
Adverse event collection as a measure of safety and tolerability	up to 3 weeks