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

Phase 1

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: DPK-060 1% ointment
Drug: Placebo for DPK-060 ointment

Registration Number: NCT01522391

Lead Sponsor: DermaGen AB

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPK-060 1% ointment	DPK-060 1% ointment	-
Placebo for DPK-060 ointment	Placebo for DPK-060 ointment	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set	Baseline and Day 14	The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set	Baseline and Day 14	The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set	Baseline, Day 7 and 21	The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set	Baseline, Day 7, Day 14 and Day 21	The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set	Baseline, Day 7, Day 14 and Day 21	The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set	Baseline, Day 7 and 21	The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set	Baseline, Day 7, Day 14 and Day 21	The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set	Baseline, Day 7, Day 14 and Day 21	The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set	Baseline, Day 7, Day 14 and Day 21	The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Change in Total Treated Eczema Area Full Analysis Set	Baseline, Day 7, Day 14 and Day 21	Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Change in Total Treated Eczema Area Per Protocol Analysis Set	Baseline, Day 7, Day 14 and Day 21	Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set	Day 7, Day 14 and Day 21	Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set	Day 7, Day 14 and Day 21	Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set	Day 7, Day 14 and Day 21	Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set	Baseline, Day 7, Day 14 and Day 21	The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Change in Area of Microbial Counting Site Full Analysis Set	Baseline, Day 7, Day 14 and Day 21	Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set	Day 7, Day 14 and Day 21	Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set	Day 7, Day 14 and Day 21	Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set	Day 7, Day 14 and Day 21	Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Investigator's Global Assessment of Eczema Change Full Analysis Set	Day 7, Day 14 and Day 21	Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set	Day 7, Day 14 and Day 21	Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Change in Area of Microbial Counting Site Per Protocol Analysis Set	Baseline, Day 7, Day 14 and Day 21	Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set	Day 7, Day 14 and Day 21	Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set	Day 7, Day 14 and Day 21	Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set	Day 7, Day 14 and Day 21	Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set	Baseline, Day 7, Day 14 and Day 21	The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set	Baseline, Day 7, Day 14 and Day 21	The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.
Patient's Global Assessment of Eczema Change Full Analysis Set	Day 7, Day 14 and Day 21	Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)