Clinical trial: Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea (NCT00041977)

Eligibility criteria:
Inclusion Criteria

          -  Healthy, post-pubescent male and females > age 18, with rosacea, 10 to 30, [papules
             and pustules] and < 2 nodules.

          -  Presence of moderate to severe erythema.

          -  Presence of telangiectasia.

          -  Female patients must utilize one of the following methods of birth control throughout
             the study: IUD, diaphragm, a condom plus the use of a spermicidal gel or foam, oral
             contraceptives (provided patient has been utilizing this method for at least 4 months
             prior to baseline and has not changed the brand within this period). Patients may also
             participate if they are surgically sterilized, in a monogamous relationship with a
             sterile partner, or sign an agreement that they will abstain from sexual intercourse
             during the course of a study.

          -  Patients must sign an informed consent form.

          -  Negative pregnancy test and non-lactating.

        Exclusion Criteria

          -  The initiation of a hormonal method of contraception within 4 months of baseline; or
             discontinuation during the course of study; or change in the actual product within 4
             months of baseline or during the study.

          -  The use of topical acne treatments within 2 weeks of baseline.

          -  The use of systemic antibiotics within 4 weeks of baseline.

          -  The use of an investigational drug with 90 days of baseline.

          -  Pregnant women or women of child-bearing potential who are not using an adequate form
             of birth control as described in Item 4 of the Inclusion Criteria.

          -  Nursing women.

          -  Patients with a known hypersensitivity to tetracyclines.

          -  Patients on clinically significant, concomitant drug therapy (See section below).

          -  The use of any acne treatment during the course of the study.

          -  The use of topical steroids 6 weeks prior to baseline and during the study.

          -  The use of systemic corticosteroids 6 weeks prior to baseline and during the study.

          -  The use of vasodilators 6 weeks prior to baseline or during the study.

          -  The use of α-adrenergic receptor-blocking agents 6 weeks prior to baseline and during
             the study.

        Prohibited Medications:

          -  Chronic use (> 14 days) of sulfa drugs, erythromycin, cephalosporins, and quinolones.

          -  The use of tetracycline antibiotics is prohibited.

          -  Use of any acne treatment during the course of the study, including spironolactone.

          -  Chronic use (> 14 days) of NSAIDs. Chronic use of aspirin at sub-analgesic doses (<
             325 mg q.d.) may be used by those patient requiring platelet aggregation inhibitor.

          -  Penicillin antibiotics should NOT be used during the course of this trial since the
             bacteriostatic action of doxycycline may interfere with the bactericidal action of
             penicillins.

          -  Antacids and vitamins containing aluminum, calcium, or magnesium may impair drug
             absorption and should be taken at least 1.5 hours before or 3.0 hours after taking
             study medication.
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? 1