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

NCT03012347 | Completed

• 1 other identifier: 19208
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Feeling any discomfort after applying the product assessed by questionnaire

  15 minutes after each application

Study Arms (1)

Sunscreen Users

EXPERIMENTAL

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; Drug: BullFrog Gel Sunscreen Land Sport SPF-50

Interventions

BAY987517 DRUG

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)

Sunscreen Users

BullFrog Gel Sunscreen Land Sport SPF-50 DRUG

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.

Sunscreen Users

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Memphis, Tennessee, 38112, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: January 5, 2017
• Primary Completion: January 19, 2017
• Study Completion: January 19, 2017
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

US (1)