Study Completed

Sunscreen Agents

Bayer Identifier:

18287

ClinicalTrials.gov Identifier:

NCT02802930

EudraCT Number:

Not Available

EU CT Number:

Not Available

Test the phototoxicity of sunscreen products

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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
Exclusion Criteria

Trial summary

Enrollment Goal

Trial Dates

April 2015 - April 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987519

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Pinellas Park, 33781, United States

Primary Outcome

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
Time Frame:
up to 1 week
Safety Issue:
Yes

Secondary Outcome

Number of adverse event as a measure of safety and tolerability
Time Frame:
up to 1 week
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

Single Blind

Assignment

Single Group Assignment

Trial Arms

Additional Information

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