4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness

NCT ID: NCT03841032

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-28
• Study Completion Date: 2019-02-25

Brief Summary

The purpose of this study is to evaluate if the test sunscreen skin care product will be well-tolerated and help facial redness when applied to the face after 4 weeks.

Conditions

Rosacea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sunscreen Lotion

Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks

Group Type: EXPERIMENTAL

Coppertone, BAY1183345

Intervention Type: DRUG

Lotion, for 4 weeks

Interventions

Coppertone, BAY1183345

Lotion, for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or females at least 18 years of age;
• Women of childbearing potential must agree to use adequate contraception when sexually active. Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception (stable dose for 3 months); (v) partner vasectomy.
• Subjects with general good health as determined by a medical history form;
• Subjects with erythematotelangiectatic and/or papulopustular rosacea, at the baseline evaluation, as determined by the Investigator;
• Subjects with Fitzpatrick Skin Types I through III, as determined by the dermatologist;
• Subjects willing and capable of understanding and providing written informed consent, willing to sign a confidentiality agreement, Health Insurance Portability and Accountability Act (HIPAA) Authorization Form, and to cooperate and participate by following study requirements.

Exclusion Criteria

• Subjects with only phymatous or ocular rosacea;
• Female subjects of child-bearing potential who test positive in a urine pregnancy test at Baseline (Visit 1), are trying to become pregnant or are nursing;
• Subjects with known allergies to any type of skin care product and/or sunscreen product and/or any ingredients in the test product;
• Subjects with any facial skin disorders which may influence results, in the opinion of the Investigator;
• Subjects with a reported history of acute or chronic dermatological (except for rosacea), uncontrolled hypertension, other medical and/or physical conditions which, in the opinion of the Investigator, interferes with evaluation of the test product or places the subject at risk;
• Subjects currently using medications or oral supplements which, in the opinion of the Investigator, may influence the outcome of the study or interfere with study observations, including rosacea treatment products;
• Individuals using or who have used any systemic medication considered to affect rosacea, specifically, but not exclusively, antibiotics or steroids, who do not agree to continue taking the specified medication at the same dose and regimen throughout the study;
• Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study;
• Subjects with excessive facial hair that would, in the opinion of the Investigator, interfere with diagnosis or assessment of rosacea;
• Subjects who spend excessive time out in the sun;
• Subjects that have received or used an Investigational New Drug within 30 days prior to the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

Countries

United States

Other Identifiers

20516

Identifier Type: -

Identifier Source: org_study_id