Clinical trial: An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea (NCT01828177)

Eligibility criteria:
Inclusion Criteria:

          -  Subject has moderate to severe papulopustular rosacea and at least mild erythema and
             mild telangiectasia.

          -  Subject is willing and able to apply the test article(s) as directed, comply with
             study instructions and commit to all follow-up visits for the duration of the study.

          -  If subject is a woman of childbearing potential, she must have a negative urine
             pregnancy test and agree to use an effective form of birth control for the duration of
             the study.

        Exclusion Criteria:

          -  Subject is pregnant, lactating or is planning to become pregnant during the study.

          -  Subject has any other active dermatological condition on the face that may interfere
             with the conduct of the study.

          -  Subject has used systemic immunosuppressants within 30 days prior to study start.

          -  Subject has used systemic retinoids within 6 months prior to study start.

          -  Subject has used any topical rosacea therapy within 14 days prior to study start.

          -  Subject has had laser or light therapy on the face within 3 months of study start.

          -  Subject is currently enrolled in an investigational drug or device study.

          -  Subject has used an investigational drug or investigational device treatment within 30
             days prior to first application of the test article.

          -  Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study
             start (except subjects on stable dose for greater than 3 months).

          -  Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment
             by an ophthalmologist.

          -  Subject has previously failed to have improvement of rosacea with appropriate use of
             systemic tetracycline family of antibiotics or use of the components of PDI-320.
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