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

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY987517; Drug: BullFrog Gel Sunscreen Land Sport SPF-50

• Registration Number: NCT03012347
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-01-04
• Study Start: 2017-01-05
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2017-01-19
• Study Completion: 2017-01-19
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunscreen Users	BAY987517	Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.
Sunscreen Users	BullFrog Gel Sunscreen Land Sport SPF-50	Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.

Primary Outcome Measures

Name	Time	Method
Feeling any discomfort after applying the product assessed by questionnaire	15 minutes after each application