To Assess the Safety of a Sunscreen Product

Bayer

Status

Completed

Conditions

Sunscreening Agents

Treatments

Drug: SPF 50 Y65 110 (BAY 987516)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02803320

18309

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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