Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)

Evaluation of a Gel Sunscreen in Controlled Use Conditions

To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Drug: BAY987517; Drug: BullFrog Gel Sunscreen Land Sport SPF-50

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects may be male or female.
• Subjects must be adults between 18 and 45 years of age.
• Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
• outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
• Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.

Exclusion Criteria:

• Subjects who have received or used an Investigational New Drug within the last 30 days.
• Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
• Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
• Subjects with respiratory allergies or asthma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Sunscreen Users; Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.

Drug: BAY987517; Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161); Drug: BullFrog Gel Sunscreen Land Sport SPF-50; Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feeling any discomfort after applying the product assessed by questionnaire	15 minutes after each application

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2017
• Primary Completion (ACTUAL): January 19, 2017
• Study Completion (ACTUAL): January 19, 2017

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 19208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No