Study Completed

Sunscreening Agents

Bayer Identifier:

19208

ClinicalTrials.gov Identifier:

NCT03012347

EudraCT Number:

Not Available

EU CT Number:

Not Available

Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)

Trial purpose

To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a
controlled indoor environment

Key Participants Requirements

Sex

Both

Age

18 - 45 Years

Inclusion Criteria
- Subjects may be male or female.
- Subjects must be adults between 18 and 45 years of age.
- Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
- outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes–acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
- Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.
Exclusion Criteria
- Subjects who have received or used an Investigational New Drug within the last 30 days.
- Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
- Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
- Subjects with respiratory allergies or asthma.

Trial summary

Enrollment Goal

Trial Dates

January 2017 - January 2017

Phase

N/A

Could I Receive a placebo

Products

BAY987517

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Memphis, 38112, United States

Primary Outcome

Feeling any discomfort after applying the product assessed by questionnaire
Time Frame:
15 minutes after each application
Safety Issue:
Yes

Trial design

Evaluation of a Gel Sunscreen in Controlled Use Conditions

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

N/A

Blinding

Single Blind

Assignment

Single Group Assignment

Trial Arms

Additional Information

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