Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea

Exclusion Criteria

• •Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea as determined by the Investigator.
• •Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea. Patients also must not grow excess facial hair during the study (i.e. they need to be free of excess facial hair for follow-up visits).
• •History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation, or known reactions to cleansers, including Ponds Cold Cream, and moisturizer with sunscreen.
• •Subjects using, or planning use of concomitant treatments within 30 days prior to Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, IPL, laser therapy or UV therapy).
• •Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin) or therapeutic vitamin A supplements of greater than 10,000 International Units/day (multivitamins are allowed).
• •Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol, Depogen, birth control pills), for less than 2 months prior to the Baseline Visit. (Subjects using estrogens for 2 months or more are not excluded unless the subject expected to change dose, drug, or discontinue estrogen use during the study).
• •Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2) systemic antibiotics known to have an impact on the severity of facial rosacea (e.g., containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim, metronidazole), or 3) systemic corticosteroids.
• •Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2) topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole, azelaic acid, erythromycin, ivermectin, sulfur based topical products).
• •Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than 5 nodules or sinus tracts.
• •Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
• •Subjects with underlying diseases or other dermatological conditions, such as; atopic dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of interfering topical or systemic therapy or may have interfered with the rosacea diagnosis.
• •Subjects using an investigational drug or participating in an investigational study within 30 days of the Baseline Visit. Use of an investigational drug and/or participation in another investigational study prohibited during this study.
• •Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse with in the past year.
• •Medical history of immunodeficiency or other significant ongoing medical condition or disease as determined by the investigator.