Clinical trial: Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients (NCT01134991)

Eligibility criteria:
Inclusion Criteria:

          1. Patients with clinical diagnosis of moderate to severe facial rosacea as determined
             by:

               -  At least 8 but no more than 50 total papules and/or pustules (inflammatory
                  lesions)

               -  Presence of moderate to severe erythema

               -  Presence of telangiectasia.

               -  An Overall Rosacea Severity score ≥2.5

          2. Patient is male or female over 18 years of age.

          3. No known medical conditions that, in the Investigator's opinion could interfere with
             study participation

          4. Patient is willing and able to comply with all requirement of the protocol

          5. Patient is willing and able to give written informed consent prior to participation in
             the study

        Exclusion Criteria:

          1. Presence of skin diseases at or near the investigational area

          2. Immunosuppressed state or other serious systemic disease

          3. Signs and/or symptoms of systemic infection

          4. Concomitant medication:

               -  Use of oral and/or topical antibiotic treatment within 14 days prior to study
                  entry.

               -  Use of any topical anti-rosacea agent except antibiotics within 14 days prior to
                  study entry.

               -  Use of cyproterone acetate, CPA-containing contraceptives (e.g. Diane) or other
                  corticosteroids (during the last 3 months);

               -  Use of retinoids (during the last 4 weeks)

          5. Use of artificial sun bath or having a sun holiday during the last 2 weeks

          6. Alcohol or drug abuse, according to assessment by the investigator

          7. Known or suspected hypersensitivity to Minocycline or any of the excipients in the
             Study Medication

          8. Use of another investigational drug within 30 days prior to entry into this study

          9. Pregnant or lactating women.
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