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

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.