check_circleStudy 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
  • - 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

Trial summary

Enrollment Goal
107
Trial Dates
May 2015 - May 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987516
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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.
    date_rangeTime Frame:
    2 days
    enhanced_encryption
    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.
    date_rangeTime Frame:
    2 days
    enhanced_encryption
    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
1

Additional Information

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