check_circleStudy Completed

Sunscreening Agents

Bayer Identifier:

18318

ClinicalTrials.gov Identifier:

NCT02779270

EudraCT Number:

Not Available

EU CT Number:

Not Available
Test the Outdoor usage for Sunscreen Products in Female Adults

Trial purpose

To assess the safety of a sunscreen product when used outdoor.

Key Participants Requirements

Sex

Female

Age

18 - 65 Years
  • - Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
    - Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
    - Subjects must agree to restrict their sun exposure activities for at least five days.
    - Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.
  • - Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
    - Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
    - Subjects must not have significantly tanned skin.
    - Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.

Trial summary

Enrollment Goal
105
Trial Dates
September 2015 - September 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987518
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
    date_rangeTime Frame:
    After approximately three hours direct sun-exposure
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Supervised Outdoor -Use Test for Sunscreen Products in Female Adults
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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