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Test the Outdoor Usage for Sunscreen Products in Female Adults

NCT ID: NCT02779270

Last Updated: 2018-12-12

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-26

Study Completion Date

2015-09-27

Brief Summary

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

Detailed Description

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Conditions

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Sunscreening Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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BAY987518

Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again.

Group Type EXPERIMENTAL

BAY987518

Intervention Type DRUG

Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

Formulation: V27-104

Sunscreen control

Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again.

Group Type ACTIVE_COMPARATOR

Sunscreen Lotion (U77-030 Control)

Intervention Type DRUG

Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

Interventions

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BAY987518

Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

Formulation: V27-104

Intervention Type DRUG

Sunscreen Lotion (U77-030 Control)

Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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St. Petersburg, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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18318

Identifier Type: -

Identifier Source: org_study_id