At a glance
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A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
In Brief
A Phase 2 clinical trial evaluating DPK-060 1% ointment and Placebo for DPK-060 ointment for Atopic Dermatitis. Completed, enrolled 41 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2