NCT01522391

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: DermaGen AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	DPK-060 1% ointment	DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
DRUG	Placebo for DPK-060 ointment	Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2012-01-31
• Last updated: 2018-12-05
• Results posted: 2018-12-05

Locations

1 site across 1 country: Sweden