Clinical trial: 4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness (NCT03841032)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? Entailment