To Assess the Safety of a Sunscreen Product

NCT ID: NCT02803320

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

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-27

Study Completion Date

2015-05-31

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.

Detailed Description

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Conditions

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Sunscreening Agents

Keywords

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Sunscreen active

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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SPF 50 Y65 110

All subjects received baseline skin evaluation and 1 day of sun exposure.

Group Type EXPERIMENTAL

SPF 50 Y65 110 (BAY 987516)

Intervention Type DRUG

Subjects applied the assigned products to all sun-exposed areas of their face and body liberally and evenly, in accordance with instructions. Sun exposure was divided into two periods. Each period consisted of direct sun exposure (out of water; Cycle A) and water exposure (Cycle B). Cycles A and B were repeated two times before study closeout.

Interventions

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SPF 50 Y65 110 (BAY 987516)

Subjects applied the assigned products to all sun-exposed areas of their face and body liberally and evenly, in accordance with instructions. Sun exposure was divided into two periods. Each period consisted of direct sun exposure (out of water; Cycle A) and water exposure (Cycle B). Cycles A and B were repeated two times before study closeout.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females, 18 to 65 years of age with no medical conditions of the skin as determined by the subjects' dermatological medical history.
* The subject must have Fitzpatrick skin types I to VI.
* During the selection process, potential subjects must agree to restrict their sun exposure activities for at least 5 days immediately preceding participation in the study. Subjects must be willing and physically able to spend approximately 3 continuous hours in the sun, must agree to immerse their entire body under water (including face and hair) at least 2 times during the water activity phase, and must agree to refrain from taking any medications during the study that might alter their response to sun exposure
* Subjects must agree to refrain from alcohol and tobacco use during the course of the study
* Subjects must obey all rules of the test facility
* Subjects must agree to refrain from tanning bed usage and significant non study related sun exposure during the study
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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18309

Identifier Type: -

Identifier Source: org_study_id