Trial Condition(s):

Sunscreening Agents

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

Bayer Identifier:

19208

ClinicalTrials.gov Identifier:

NCT03012347

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

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

January2017

Phase

N/A

Could I receive a placebo?

Products

BAY987517

Accepts Healthy Volunteers

Yes

Where to Participate

Locations

Locations
Locations Investigative Site Memphis, United States, 38112	Contact Us: E-mail: [email protected] Phone: Not Available

Investigative Site

Memphis, United States, 38112

Contact Us:

E-mail: [email protected]

Phone: Not Available

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:

Primary Outcome

Feeling any discomfort after applying the product assessed by questionnaire
Timeframe: 15 minutes after each application

Sunscreening Agents

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

45 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Additional Information