A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060

Summary

The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was preceded with an open-label investigation in a small group of patients (n=5) treated with two applications of DPK-060 1% ointment per day for four days to assess safety, local tolerability and systemic absorption of DPK-060. The secondary objectives were to evaluate severity of eczema and pruritus, to assess the tolerability and safety of the treatment and to assess the degree of systemic absorption of DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.

Timeline

Start

2008-03

Primary completion

2009-04

Completion

2009-04

Outcome

Met primary endpoint

registry analysis (other test); Placebo for DPK-060 Ointment vs DPK-060 1% Ointment; p = 0.012; Ratio between geometric means 0.045 (95% CI 0.004 to 0.491) NCT01522391 ↗

Drugs

Indications