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Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

NCT ID: NCT02831478

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

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-09

Study Completion Date

2016-07-10

Brief Summary

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To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

Detailed Description

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Conditions

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Sunscreening Agent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BAY987517

2/3 of subjects testing the test article

Group Type EXPERIMENTAL

BAY987517

Intervention Type DRUG

Applied liberally to the skin (Formulation: RB# Z16-071)

Sunscreen Lotion

1/3 of subjects testing the marketed control

Group Type ACTIVE_COMPARATOR

Sunscreen Lotion (RB# T78-190B)

Intervention Type DRUG

Applied liberally to the skin

Interventions

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BAY987517

Applied liberally to the skin (Formulation: RB# Z16-071)

Intervention Type DRUG

Sunscreen Lotion (RB# T78-190B)

Applied liberally to the skin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
* Subjects must have Fitzpatrick Skin Type I, II, III or IV.
* Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion Criteria

* Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
* Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
* Subjects must not have significantly tanned skin.
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 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

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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18533

Identifier Type: -

Identifier Source: org_study_id