Trial Condition(s):

Sunscreening Agents

To assess the safety of a sunscreen product

Bayer Identifier:

18309

ClinicalTrials.gov Identifier:

NCT02803320

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor use conditions.

Inclusion Criteria
:
 -  Healthy males or females, 18 to 65 years of age with no medical conditions of the skin as determined by the subjects’ dermatological medical history.
 -  The subject must have Fitzpatrick skin types I to VI.
 -  During the selection process, potential subjects must agree to restrict their sun exposure activities for at least 5 days immediately preceding participation in the study. Subjects must be willing and physically able to spend approximately 3 continuous hours in the sun, must agree to immerse their entire body under water (including face and hair) at least 2 times during the water activity phase, and must agree to refrain from taking any medications during the study that might alter their response to sun exposure
 -  Subjects must agree to refrain from alcohol and tobacco use during the course of the study
 -  Subjects must obey all rules of the test facility
 -  Subjects must agree to refrain from tanning bed usage and significant non study related sun exposure during the study
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
107
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BAY987516
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

St. Petersburg, United States, 33714

Status
Completed
 

Trial Design