Randomized comparison of the type 4 phosphodiesterase inhibitor cipamfylline cream, cream vehicle and hydrocortisone 17-butyrate cream for the treatment of atopic dermatitis

Abstract

Summary Background Therapeutic options to treat atopic dermatitis are limited. Leukocytes from atopic patients have an abnormally high activity of cyclic adenosine monophosphate (AMP)–phosphodiesterase (PDE), which can be normalized in vitro by PDE inhibitors. Cipamfylline is a new potent and selective inhibitor of PDE‐4. Objectives To compare the efficacy and safety of up to 14 days’ topical treatment with cipamfylline (0·15%) cream with vehicle and with hydrocortisone 17‐butyrate (0·1%) cream. Patient and methods International, multicentre, prospective, randomized double‐blind, left–right studies of cipamfylline vs. vehicle and cipamfylline vs. hydrocortisone 17‐butyrate in adult patients with stable symmetrical atopic dermatitis on the arms. Results Both cipamfylline and hydrocortisone 17‐butyrate reduced the Total Severity Score significantly (P < 0·001). The reduction with cipamfylline was significantly greater than that with vehicle (difference vehicle–cipamfylline 1·67 95% confidence interval (CI) 1·06, 2·28; P < 0·001) and was significantly less than with hydrocortisone 17‐butyrate (difference hydrocortisone–cipamfylline −2·10 95% CI −2·93, −1·27; P < 0·001). Investigator and patient assessments of the overall treatment response showed a similar picture. Conclusions Cipamfylline cream is significantly more effective than vehicle, but significantly less effective than hydrocortisone 17‐butyrate cream in the treatment of atopic dermatitis.