Trial Condition(s):
Sunscreening Agents
To assess the safety of a sunscreen product
Bayer Identifier:
18309
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT 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
Phase
N/A
Could I receive a placebo?
No
Products
BAY987516
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site St. Petersburg, United States, 33714 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Dermatologist´s subjective and objective assessments of potential Adverse events• “product related,” • “likely product related,” • “unlikely product related, or “not product related.Timeframe: 2 days
- 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.Timeframe: 2 days
Additional Information
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