RESUMO
BACKGROUND: Rosacea is a chronic skin condition that typically affects the face and it results in redness and inflammation. The main risk factors of this disease are Demodex folliculorum, living in the pilosebaceous units. AIMS: To evaluate the efficacy and safty of permethrin 2.5% in combination with tea tree oil (TTO) topical gel versus placebo on Demodex density (Dd) and clinical manifestation using standard skin surface biopsy (SSSB) in rosacea patients. PATIENT/METHODS: In this double-blind, randomized clinical trial, 47 papulopustular rosacea patients were enrolled, with 35 patients finishing the 12 weeks of treatment. Each patient used permethrin 2.5% with TTO on one side of the face and a placebo on the other, twice daily for 12 weeks. SSSB, photography and clinical rosacea scores according to National Rosacea Society, as well as adverse drug reaction (ADRs) were reported at the baseline, 2nd, 5th, 8th, and 12th weeks. RESULTS: A total of 47 patients were enrolled with papulopustular rosacea, and 35 patients finished the study. The effects of permethrin 2.5% with TTO gel on mite density were significant at week 5, 8, 12 (P value = .001). Clinical features and global assessments showed papules, pustules and nontransient erythema had improvement in drug group after 12 weeks (P values <.05). The improvement of burning and stinging and dry appearance was greater than the placebo gel (P value <.05). Itching in placebo group was significantly more than other group (P value = .002). CONCLUSION: Administration of permethrin 2.5% with TTO gel demonstrated good efficacy and safety in rosacea. This topical gel inhibited the inflammatory effects of rosacea and reduced Demodex mite.
