brand finacea 15% gel

Acne Vulgaris

Azelaic acid 20% cream is used topically in the treatment of mild to moderate inflammatory acne vulgaris. The drug is not indicated in the treatment of noninflammatory acne vulgaris. Therapy of acne vulgaris must be individualized and frequently modified depending on the types of acne lesions that predominate and the response to therapy. Results of several studies indicate that topical azelaic acid 20% cream is more effective than vehicle placebo in the treatment of mild to moderate inflammatory acne and as effective as topical tretinoin or benzoyl peroxide. Limited data indicate that topical azelaic acid also may be as effective as oral tetracycline hydrochloride in the management of acne vulgaris. A decrease in the number of inflammatory lesions occurs in most patients within 1-2 months of topical azelaic acid therapy, although maximum benefit generally requires more prolonged treatment.

Rosacea

Azelaic acid 15% gel is used topically for the treatment of inflammatory lesions (papules and pustules) associated with mild to moderate rosacea in adults. In 2 clinical studies in adults with mild to moderate papulopustular rosacea, therapy with azelaic acid 15% gel (applied twice daily for 12 weeks) resulted in a 50-58% reduction in the number of papules and pustules compared with a 38-40% reduction in patients receiving vehicle alone. Patients were instructed to avoid spicy foods, thermally hot foods and drinks, and alcoholic beverages during the treatment period, as well as to use only very mild soaps or soapless cleansing lotion for facial cleaning. Azelaic acid 20% cream also has been used with some success in the treatment of papulopustular rosacea.

Administration

Azelaic acid is applied topically to the skin as a 20% cream or 15% gel. Prior to application of the cream or gel, the affected areas should be cleansed and dried. The cream or gel is then applied and massaged gently into the affected areas. Occlusive dressings or wrappings should not be used, and hands should be washed after applying the cream or gel. Cosmetics may be applied to the skin after the gel has dried. The cream or gel should not be applied to the eye. In addition, contact with the mouth, eyes, and other mucous membranes should be avoided. If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists.

The manufacturer states that patients receiving azelaic acid gel for the treatment of rosacea should be instructed to avoid spicy foods, thermally hot foods and drinks, and alcoholic beverages and to use only very mild soaps or soapless cleansing lotions for facial cleaning during therapy with the drug.

Skin irritation (e.g., pruritus, burning, stinging) may occur during the initial weeks of therapy with azelaic acid cream or gel; if irritation is excessive or persists, the drug should be discontinued and the clinician should be contacted. Patients with dark complexions should be monitored for early signs of hypopigmentation during azelaic acid therapy.

Dosage

The manufacturer states that safety and efficacy of azelaic acid cream in children younger than 12 years of age have not been established. The manufacturer states that safety and efficacy of azelaic acid gel in pediatric patients have not been established.

Acne Vulgaris

For the topical treatment of acne vulgaris, a thin film of azelaic acid 20% cream should be applied to the cleansed affected area twice daily (morning and evening). Improvement usually is detectable within 1-2 months of topical therapy with the drug. Optimum duration of therapy depends on the severity of the acne. Although most reported experiences to date have been for treatment periods that did not exceed 6 months, topical azelaic acid therapy has been used for up to a year or longer in appropriately selected cases for control of individual lesions, and repeat courses have been employed for recurrences. however, some clinicians suggest that treatment with azelaic acid should not exceed 6 months.

Rosacea

For the treatment of rosacea, a thin layer of azelaic acid 15% gel should be applied to the affected area twice daily (morning and evening). The manufacturer states that safety and efficacy of therapy with azelaic acid gel have not been established beyond 12 weeks.