To Assess the Safety of a Sunscreen Product

Bayer107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

107

Conditions

Sunscreening Agents

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

St. Petersburg, Florida, United States

Outcomes

Primary Outcomes

Dermatologist´s subjective and objective assessments of potential Adverse events

• "product related," • "likely product related," • "unlikely product related, or "not product related.

Time frame: 2 days

Final Skin Evaluation

• 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.

Time frame: 2 days

Data from ClinicalTrials.gov

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