Clinical trial: Effects of PRK 124 Lotion in Acne Rosacea (NCT00580723)

Eligibility criteria:
Inclusion Criteria:

          -  be at least 21 years old

          -  be in reasonably good health as defined by the study doctor

          -  have routine laboratory tests to evaluate your blood cell count, and kidney and liver
             function

          -  for females of child-bearing age, not be pregnant or nursing and have a negative urine
             pregnancy test (except if surgically sterile or at least 1 year menopausal)

          -  for females, agree to use medically acceptable forms of birth control throughout the
             entire study (medically acceptable forms of birth control include oral contraceptive
             ["the pill"], implants such as Norplant®, injectable progesterone [Depo-provera®],
             diaphragm and spermicide or condoms and spermicide)

          -  must have mild to moderate acne rosacea

          -  be willing to refrain from using non-approved lotions, moisturizer, cleansers or
             lotions on affected facial areas during the treatment period

          -  be capable of understanding and giving written, voluntary informed consent before
             study screening

          -  be willing to consent to facial photographs at baseline and each follow-up visit to
             monitor treatment with the test product.

        Exclusion Criteria:

          -  have a history or evidence of any chronic or reoccurring skin disease or disorder
             (e.g., psoriasis, eczema, etc.) affecting the face

          -  have known or suspected hypersensitivity to study treatment or any of its ingredients

          -  have used systemic retinoids within 6 months prior to study entry (e.g., acitretin,
             isotretinoin)

          -  have received treatment with systemic corticosteroids (e.g. prednisone) or antibiotics
             within 1 month

          -  have used topical treatment to the face with retinoids (e.g. tretinoin, adapalene), or
             antibiotics or corticosteroids, within 2 weeks prior to study entry

          -  are unwilling to use a sunscreen with an SPF of 30 during the study

          -  have participated in any clinical trial involving an investigational drug or cosmetic
             product or procedure within the past 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 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