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

Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - Any
Start Date:January 29, 2019
End Date:March 11, 2019
Contact:Bayer Clinical Trials Contact
Phone:(+)1-888-84 22937

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4 Week In-Use Study Evaluating the Tolerability of a Skin Care Product on Adults With Rosacea

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.

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

- 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.
We found this trial at
2095 Langhorne Road
Lynchburg, Virginia 24501
Lynchburg, VA
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