To Assess the Safety of a Sunscreen Product

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.

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Key information

Conditions

Sunscreening Agents

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg, Florida, 33714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPF 50 Y65 110 (BAY 987516)

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.

Primary outcomes

Dermatologist´s subjective and objective assessments of potential Adverse events

Time frame: 2 days
- "product related," • "likely product related," • "unlikely product related, or "not product related.
Final Skin Evaluation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Supervised Outdoor -Use Test to Assess the Safety of a Sunscreen Lotion on Sports Users

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jun 16, 2016
Registry last updated: Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed