Clinical trial: Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea (NCT03418610)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female subjects age 18 or older.

          2. Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or
             4-severe.

          3. Presence of 12 - 50 inflammatory lesions and persistent erythema with or without
             telangiectasia.

          4. Subjects must read, understand, and sign the Informed Consent.

          5. Subjects must be willing and able to comply with study procedures and visit schedule
             requirements.

          6. Women of childbearing potential that are willing to use an acceptable method of
             contraception during the study.

        Exclusion Criteria:

          1. Active or localized or systemic infections.

          2. Subjects must not be immunocompromised.

          3. Known unresponsiveness or allergy to azelaic acid.

          4. Subjects unlikely to comply with the protocol, e.g. mental condition rendering the
             patient unable to understand the nature, scope, and possible consequences of the
             clinical study, uncooperative attitude or unlikelihood of completing the study (e.g.
             drug or alcohol abuse).

          5. Subjects must not be pregnant or breastfeeding.

          6. Presence of dermatoses that might interfere with the ability to diagnose and/or
             evaluate rosacea.

          7. Presence of other types of rosacea.

          8. Laser surgery on the face for the treatment of telangiectasia or other conditions
             within 6 weeks of study enrollment.

          9. Use of medications or products for the treatment of rosacea or other medical
             conditions within the following time periods prior to study enrollment. Use of these
             medications will be prohibited during the trial.

             Topical Prescription or Nonprescription medications 6 weeks Oral retinoids 6 months
             Tetracycline (ex. doxycycline, minocycline 2 months Corticosteroids 4 weeks
             Erythromycin or azithromycin 4 weeks Other systemic medications to treat rosacea 6
             weeks

         10. Refusal to sign the Informed Consent document or Photo Release document and/or refusal
             to comply with all follow-up requirements.

         11. Use of medications that are known to cause flushing.

         12. Dose changes in the last 90 days or initiation of beta-blockers, vasodilators,
             vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other
             drugs known to cause acneform eruptions.

             -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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