Trial Condition(s):

Sunscreen agents

Test the phototoxicity of sunscreen products

Bayer Identifier:

18287

ClinicalTrials.gov Identifier:

NCT02802930

EudraCT Number:

Not Available

Study Completed

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.

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
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BAY987519
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Pinellas Park, United States, 33781

Status
Completed
 

Trial Design