K J McClellan1, S Noble. 1. Adis International Limited, Auckland, New Zealand. demail@adis.co.nz
Abstract
UNLABELLED: Topical application of the antibacterial agent metronidazole is effective in the treatment of moderate to severe rosacea, although its mechanism of action has yet to be clearly established. Metronidazole preparations (0.75 and 1% cream, 0.75% gel and 0.75% lotion) were significantly more effective than placebo in patients with moderate to severe rosacea when administered to the affected area once or twice daily for 7 to 12 weeks. The mean number of papules and pustules decreased by between 48 and 65.1% during the treatment period. Reductions were fairly consistent regardless of formulation, strength or application frequency and were significant compared with placebo (p < 0.05). In 1 study, most of the overall effects of metronidazole were observed within the first 3 weeks. Although data are limited, topical metronidazole appears to improve inflammatory lesions and erythema as effectively as oral tetracyclines. Like tetracyclines, however, metronidazole has no effect on telangiectasia. Metronidazole 0.75% gel seems to be effective in maintaining remission of rosacea symptoms in patients successfully treated with both oral tetracycline and topical metronidazole. In the only study, 77% of patients treated with metronidazole gel compared with 58% of placebo recipients (p < 0.05) remained in remission 6 months after the tetracycline was stopped. The effects of topical metronidazole preparations on rosacea symptoms are palliative, not curative, but preliminary data suggest that relapse rates after cessation of therapy are no worse than those after cessation of oral oxytetracycline. Topical metronidazole formulations are generally well tolerated locally, with stinging, dryness, burning and itching reported in < or = 2% of patients. Because minimal concentrations of metronidazole are absorbed after topical administration, systemic adverse events and drug interactions seen with oral or intravenous metronidazole are unlikely. CONCLUSIONS:Topical metronidazole formulations are significantly more effective than placebo when used in the initial treatment of patients with moderate to severe rosacea. Furthermore, limited evidence suggests that the use of topical metronidazole alone may be as effective as oral tetracyclines against the disorder's inflammatory component. Therefore, for those patients with a preference for topical rather than oral therapy, the use of a topical metronidazole formulation must be a consideration.
RCT Entities:
UNLABELLED: Topical application of the antibacterial agent metronidazole is effective in the treatment of moderate to severe rosacea, although its mechanism of action has yet to be clearly established. Metronidazole preparations (0.75 and 1% cream, 0.75% gel and 0.75% lotion) were significantly more effective than placebo in patients with moderate to severe rosacea when administered to the affected area once or twice daily for 7 to 12 weeks. The mean number of papules and pustules decreased by between 48 and 65.1% during the treatment period. Reductions were fairly consistent regardless of formulation, strength or application frequency and were significant compared with placebo (p < 0.05). In 1 study, most of the overall effects of metronidazole were observed within the first 3 weeks. Although data are limited, topical metronidazole appears to improve inflammatory lesions and erythema as effectively as oral tetracyclines. Like tetracyclines, however, metronidazole has no effect on telangiectasia. Metronidazole 0.75% gel seems to be effective in maintaining remission of rosacea symptoms in patients successfully treated with both oral tetracycline and topical metronidazole. In the only study, 77% of patients treated with metronidazole gel compared with 58% of placebo recipients (p < 0.05) remained in remission 6 months after the tetracycline was stopped. The effects of topical metronidazole preparations on rosacea symptoms are palliative, not curative, but preliminary data suggest that relapse rates after cessation of therapy are no worse than those after cessation of oral oxytetracycline. Topical metronidazole formulations are generally well tolerated locally, with stinging, dryness, burning and itching reported in < or = 2% of patients. Because minimal concentrations of metronidazole are absorbed after topical administration, systemic adverse events and drug interactions seen with oral or intravenous metronidazole are unlikely. CONCLUSIONS: Topical metronidazole formulations are significantly more effective than placebo when used in the initial treatment of patients with moderate to severe rosacea. Furthermore, limited evidence suggests that the use of topical metronidazole alone may be as effective as oral tetracyclines against the disorder's inflammatory component. Therefore, for those patients with a preference for topical rather than oral therapy, the use of a topical metronidazole formulation must be a consideration.