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

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: BullFrog Gel Sunscreen Land Sport SPF-50; Drug: BAY987517

Study type: Interventional

Funder types: Industry

Identifiers

NCT03012347

19208

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

72 participants in 1 patient group

Sunscreen Users

Experimental group

Description:

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.

Treatment:

Drug: BullFrog Gel Sunscreen Land Sport SPF-50

Drug: BAY987517