Estudio comparativo de la efectividad, tolerabilidad y seguridad de furoato de mometasona en combinación con mupirocina y clotrimazol (DermaQ®) vs la combinación dexametasona, neomicina y clotrimazol (Baycuten®) en sujetos con procesos inflamatorios de piel asociados a sospecha de infección bacteriana y/o micótica

Background: A randomized, open, multicentric, active comparator-controlled study was conducted on patients with a diagnosis of acute eccema complicated with suspect of infection to evaluate the efficacy, safety and tolerability of mometasone furoate plus mupirocine and clothrimazole (DermaQ® Galeno-D) versus dexamethasone, neomycin and clothrimazole (Baycuten® Bayer-B). Methods: Approval for the protocol, case report form and inform consent document was obtained from the Ethics Committees and all patients gave their written informed consent before any protocol-related procedure. Male or female patients, older than 18 years were included and randomized to receive DermaQ® or Baycuten® cream twice a day for 7 - 13 days. Efficacy was assessed by Signs/ Symptoms scale and pruritus VAS scale at Day 7 (visit 1) and if cure was not obtained, they continued treatment until 10-13 days when they were reassessed; adverse events recording was used to assess safety. Results: One hundred and seventy patients were screened. One patient developed erysipela and was excluded for any evaluation. One hundred and sixty-nine patients (90 male - 79 female; 18 - 95 years old), mean age 44.1 years old were included. Half of them received D and the other half received B. Efficacy was similar for both drugs at visit 1 and at visit 2. Only one patient developed an adverse event (skin atrophy, Group B) Conclusion: in this trial DermaQ® showed high efficacy and safety in patients with dermatologic inflammatory conditions and suspicion of bacterial or mycotic infection, achieving a cure rate of 87,2% vs 83,6% with Baycuten® (n.s.). DermaQ® is a convenient option for the treatment of patients with this condition.