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

NCT ID: NCT03012347

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-05

Study Completion Date

2017-01-19

Brief Summary

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

Detailed Description

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Conditions

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Sunscreening Agents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sunscreen Users

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.

Group Type EXPERIMENTAL

BAY987517

Intervention Type DRUG

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)

BullFrog Gel Sunscreen Land Sport SPF-50

Intervention Type DRUG

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.

Interventions

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BAY987517

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)

Intervention Type DRUG

BullFrog Gel Sunscreen Land Sport SPF-50

Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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19208

Identifier Type: -

Identifier Source: org_study_id