Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users

NCT ID: NCT02857478

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

2015-06-27

Study Completion Date

2015-06-28

Brief Summary

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The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.

Detailed Description

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Conditions

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Sunscreen Agents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Safety of a Sunscreen product

Sunscreen product safety evaluation under supervised out-door conditions on sport users.

Group Type EXPERIMENTAL

BAY 987519, SPF 50, Y51-002

Intervention Type DRUG

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

BAY 987519, SPF 50, P04-147

Intervention Type DRUG

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Interventions

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BAY 987519, SPF 50, Y51-002

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Intervention Type DRUG

BAY 987519, SPF 50, P04-147

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, aged 18 to 65 years
* No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
* Must not have visible erythema, blistering or peeling that would indicate recent sunburn
* Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
* Must not be taking any medication in which exposure to the sun is contraindicated
* Must be willing to obey all rules of the test facility
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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18317

Identifier Type: -

Identifier Source: org_study_id