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

DermaGen

Status and phase

Completed

Phase 2

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: DPK-060 1% ointment

Drug: Placebo for DPK-060 ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01522391

DCS-001

2007-007103-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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