Study Completed

Sunscreening Agents

Bayer Identifier:

18309

ClinicalTrials.gov Identifier:

NCT02803320

EudraCT Number:

Not Available

EU CT Number:

Not Available

To assess the safety of a sunscreen product

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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

Trial summary

Enrollment Goal

107

Trial Dates

May 2015 - May 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987516

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		St. Petersburg, 33714, United States

Primary Outcome

Dermatologist´s subjective and objective assessments of potential Adverse events
• “product related,” • “likely product related,” • “unlikely product related, or “not product related.
Time Frame:
2 days
Safety Issue:
Yes
Final Skin Evaluation
• Score 0 (no response): Normal skin. No visible response or erythema. up to Score 3 (severe response): A well demarcated area of very intense or “beet” red erythema or an area of the skin affected by significant edema, papules, and/or vesicles. Usually symptomatic and may require therapeutic intervention.
Time Frame:
2 days
Safety Issue:
Yes

Trial design

Supervised Outdoor -Use test to assess the Safety of a sunscreen Lotion on Sports users

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Single Blind

Assignment

Single Group Assignment

Trial Arms

Additional Information

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