To Assess the Safety of a Sunscreen Product

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: SPF 50 Y65 110 (BAY 987516)

• Registration Number: NCT02803320
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-05-27
• Primary Completion: 2015-05-29
• Study Completion: 2015-05-31
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPF 50 Y65 110	SPF 50 Y65 110 (BAY 987516)	All subjects received baseline skin evaluation and 1 day of sun exposure.

Primary Outcome Measures

Name	Time	Method
Dermatologist´s subjective and objective assessments of potential Adverse events	2 days	• "product related," • "likely product related," • "unlikely product related, or "not product related.
Final Skin Evaluation	2 days	• Score 0 (no response): Normal skin. No visible response or erythema. up to Score 3 (severe response): A well demarcated area of very intense or "beet" red erythema or an area of the skin affected by significant edema, papules, and/or vesicles. Usually symptomatic and may require therapeutic intervention.