Test the Phototoxicity of Sunscreen Products



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:12/14/2018
Start Date:April 20, 2015
End Date:April 26, 2015

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

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

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
We found this trial at
1
site
Clinical Trial Facility in Pinellas Park Florida
Pinellas Park, Florida
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials