A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

Exclusion Criteria

• •Pregnant or lactating or planning to become pregnant during the study period.
• •Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea.
• •Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea.
• •History of hypersensitivity or allergy to azelaic acid, propylene glycol or any other component of the formulation.
• •The use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• •The use of estrogens or oral contraceptives for less than 3 months prior to baseline.
• •The use within 1 month prior to baseline 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);
• •3. systemic corticosteroids (Note: intranasal and inhalational corticosteroids do not require a washout and maybe used throughout the trial if the subject is on a stable dose).
• •Use within 2 weeks prior to baseline of:
• •1. topical corticosteroids;
• •2. topical antibiotics;
• •3. topical medications for rosacea (e.g., metronidazole).
• •Patients with moderate or severe rhinophyma, dense telangiectases (score 3, severe), or plaque-like facial edema.
• •Patients with a severe irritation grade for erythema, dryness, scaling, pruritus, stinging/burning, and edema.
• •Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
• •A patient who has used a sauna during the 2 weeks prior to study entry and during the study.
• •Patients who have performed wax epilation of the face within 14 days prior to baseline
• •A patient who has a history of being unresponsive to topical azelaic acid therapy.
• •A patient with bacterial folliculitis.
• •A patient who consumes excessive alcohol, abuses licit or illicit drugs, or has a condition that could compromise the patient's ability to comply with study requirements.
• •Patients who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
• •A patient who has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study.
• •A patient who has used any topical azelaic acid therapy within 30 days of baseline visit.
• •Patients who have participated in an investigational drug study (i.e., patients have been treated with an Investigational Drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
• •Patients who have been previously enrolled in this study.
• •Patients who have had laser therapy (for telangiectasia or other conditions), electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry.
• •Patients who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the Investigational Product within 14 days prior to study entry.