Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo

A Multicenter, Randomized, Double-blind, Placebo-controlled Evaluation of Rosacea-related Inflammatory Biochemical Markers in the Skin of Adults With Papulopustular Rosacea Treated With Daily Doxycycline 40 mg (30 mg Immediate Release / 10 mg Delayed Release Beads) Capsules

The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with rosacea-related inflammatory markers.

Inclusion Criteria:

• Subject is male or female aged 18 to 70 years inclusive
• Subject with papulopustular rosacea (5 to 40 papules or pustules)

Exclusion Criteria:

• Subject has any other active dermatological condition on face that may interfere with the conduct of the study
• Subject uses proton pump inhibitors for treatment of gastroesophageal reflux within 30 days prior to baseline visit or during the study
• Subject uses spironolactone within 30 days prior to baseline visit or during the study
• Subject requires chronic treatment (>14 days) with sulfa drugs, erythromycin, cephalosporins and quinolones within 30 days prior to baseline visit or during the study
• Subject has used tetracycline antibiotics within 30 days prior to baseline visit or during the study
• Subject has used penicillin antibiotics within 30 days prior to baseline visit or during the study
• Subject uses topical or oral dapsone
• Subject has had a change in hormonal therapy within 3 months of initiation of therapy or during the study
• Subject has used systemic immunosuppressants (e.g. corticosteroids, cyclosporine, imuran, biologics, mycophenolate mofetil) within 30 days prior to baseline visit. For subjects who have received treatment with biologics, treatment must have been discontinued within 90 days prior to baseline
• Subject has used any systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
• Subject has used systemic retinoids within 6 months of the baseline visit
• Subject takes niacin at a dosage of 500 mg or more per day
• Subject has used any topical rosacea therapy including topical antibiotics, topical retinoids, topical sodium sulfacetamide preparations, topical benzoyl peroxides, topical vasoconstricting agents (e.g., oxymetazoline) topical calcineurin inhibitors (e.g. tacrolimus, pimecrolimus) within 30 days prior to baseline visit
• Subject has been treated with another investigational drug or device within 30 days of baseline visit. For subjects who received experimental biologic treatment, treatment must have been discontinued within five half lives of the baseline visit.
• Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines
• Subject is using a clinically significant concomitant drug (e.g., use of long term non-steroidal anti-inflammatory agents unless used only on a PRN basis less than 7 days per month)
• Subject has used vasodilators or an adrenergic blocking agent within 6 weeks of baseline visit (except subjects on stable dose for greater than 3 months)
• Subject has had laser or light therapy on the face within 3 months of the baseline visit
• Subject with active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist
• Subject with rhinophymatous rosacea
• Subject with a history of noncompliance with a treatment regimen
• Subject is at risk in terms of precautions, warnings, and contraindications (see package insert)
• Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
• Subjects with a recent history of alcohol and/or drug abuse