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

Inclusion criteria

• A clinical diagnosis of atopic dermatitis
• Treatable eczematous lesions of a total area of at least 25 cm2 (100 cm2 for the initial five patients)
• Female patients of childbearing potential had to be using an appropriate method of contraception.
• Female patients of childbearing potential were not eligible before PK data from the first 10 patients had been evaluated and the Medical Products Agency (Swedish regulatory agency) had given approval to include women of childbearing potential.

Exclusion criteria

• Significant clinical illness, within the two weeks prior to first dose, which could affect the outcome of the study
• Previous local or systemic antimicrobial therapy within the last four weeks prior to the first application of the investigational product (DPK-060 1% or placebo ointment)
• Existence of any surgical or medical condition which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
• Patients who had had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies)on the site of eczema within 14 days prior to first application of DPK-060 1% or placebo ointment and/or topical treatment with tar, any corticosteroid,topical immunomodulators or oral treatment with any corticosteroids within 14 days prior to first application and/or oral antihistamines within 14 days of the first dose.
• A need for any other medication during the period 0 to 7 days before entry to the study, (excluding the oral contraceptive pill for females) except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study
• Diagnosis of other skin diseases, which in the opinion of the investigator, were likely to adversely affect the outcome of the study
• History or evidence of significant cardiac, renal, hepatic or endocrine disease
• Significant hypersensitivity or allergy, as judged by the investigator
• Immunocompromised patients
• Lice or scabies
• Tinea corporis
• Hypersensitivity to the ingredients of the vehicle
• The presence of prominent tattoos at sites of application of DPK-060 1% or placebo ointment
• Donation of blood, exceeding 450 mL, during the three months prior to first dose
• Participation in a clinical study during the 12 weeks prior to first dose
• Ongoing alcohol or drug abuse
• Positive pregnancy test or lactation