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

Sunscreening Agents Clinical Trial

Official title:

Evaluation of a Gel Sunscreen in Controlled Use Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012347
• Other study ID #: 19208
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: December 6, 2017
• Start date: January 5, 2017
• Est. completion date: January 19, 2017

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

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)
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeling any discomfort after applying the product assessed by questionnaire		15 minutes after each application

External Links

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