Test the Phototoxicity of Sunscreen Products

Not Applicable

Completed

• Conditions: Sunscreen Agents
• 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: NCT02802930
• Lead Sponsor: Bayer

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 Description

Not available

Study Timeline

• Study Start: 2015-04-20
• Primary Completion: 2015-04-26
• Study Completion: 2015-04-26
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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 Y51 002 (BAY987519)	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.
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	Sodium chloride [NaCl]	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.
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	SPF 15 V27 104 (BAY987519)	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.
SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104	SPF 50 Y65 110 (BAY987519)	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.

Primary Outcome Measures

Name	Time	Method
Skin irritation	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

Secondary Outcome Measures

Name	Time	Method
Number of adverse event as a measure of safety and tolerability	up to 1 week