The treatment of atopic dermatitis with topical fusidic acid and hydrocortisone acetate

Abstract

Aim To compare the clinical efficacy of a cream combination containing 2% fusidic acid and 1% hydrocortisone acetate in the treatment of patients with mild to moderate atopic dermatitis.Subject Atopic dermatitis and efficacy of antibacterial and antiinflammatory topical therapy.Methods Randomized, double blind, prospective, parallel group trials.Results Study I, involving 186 patients, compared the combination 2% fusidic acid and 1% hydrocortisone acetate with 1% hydrocortisone cream. Analysis was performed on patients who had pathogens at entry and on the total patient population. Study II, involving 68 patients, compared the combination 2% fusidic acid and 1% hydrocortisone acetate with 2% fusidic acid cream. Analysis was the same as in study I.Results of study I in patients with pathogens at baseline showed a significant difference in favour of the combination (P = 0.04) in terms of the primary efficacy criterion which was a combination of clinical and bacteriological efficacy measures. When all patients in the study were analyzed there was no significant difference between the two groups. The combination was significantly more effective in removing pathogens than 1% hydrocortisone cream (P < 0.0001).Results of study II in all patients showed that the combination was significantly better than 2% fusidic acid cream (P = 0.04) in terms of the primary efficacy criterion. Both preparations were highly successful in eradicating pathogens.Pooled analysis of studies I and II showed a difference with respect to the primary efficacy criterion among the 3 preparations in the order Fucidin 2% plus HC 1% cream > HC 1% cream > Fucidin 2% cream in all patients and in those with pathogens (P = 0.007 for all patients and P = 0.01 for those with pathogens). Similarly, regarding the reduction in sign/symptom score a significant difference among the 3 preparations existed (P = 0.009 for all patients and P = 0.01 for those with pathogens). Adverse events with the combination were minimal.Conclusion 2% fusidic acid and 1% hydrocortisone acetate cream is an effective therapy in patients with mild to moderate degrees of atopic dermatitis.