Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which Metronidazole Topical Lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. Metronidazole Topical Lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigators' global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table:

The scale is based on the following definitions:

Worse: Exacerbation of either erythema or quantitative assessment of papules and/or pustules.

No Change: Condition remains the same.

Minimal Improvement: Slight improvement in the quantitative assessment of papules and/or pustules, and/or slight improvement in erythema.

Definite Improvement: More pronounced improvement in the quantitative assessment of papules and/or pustules, and/or more pronounced improvement in erythema.

Marked Improvement: Obvious improvement in the quantitative assessment of papules and/or pustules, and/or obvious improvement in erythema.

Clear: No papules or pustules and minimal residual or no erythema.