Back to resultsA Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
DPK-060 1% ointment
Placebo for DPK-060 ointment
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
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
Sites / Locations
- Quintiles Hermelinen AB
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo for DPK-060 ointment
DPK-060 1% ointment
Arm Description
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set
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
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Secondary Outcome Measures
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set
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 7 and 21 Per Protocol Analysis Set
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
The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
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
The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
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
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
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
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Change in Total Treated Eczema Area Per Protocol Analysis Set
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Change in Area of Microbial Counting Site Full Analysis Set
Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Change in Area of Microbial Counting Site Per Protocol Analysis Set
Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
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) Full Analysis Set
Evaluation of excoriations 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
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
Evaluation of infiltration 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
Evaluation of infiltration 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
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) Per Protocol Analysis Set
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
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
Investigator'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
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
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
Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01522391
Brief Title
A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
Official Title
A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DermaGen AB
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo for DPK-060 ointment
Arm Type
Placebo Comparator
Arm Title
DPK-060 1% ointment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DPK-060 1% ointment
Intervention Description
DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
Intervention Type
Drug
Intervention Name(s)
Placebo for DPK-060 ointment
Intervention Description
Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set
Description
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame
Baseline and Day 14
Title
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set
Description
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame
Baseline and Day 14
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set
Description
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame
Baseline, Day 7 and 21
Title
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set
Description
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame
Baseline, Day 7 and 21
Title
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Description
The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Description
The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Description
The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Description
The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Description
The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Description
The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Change in Total Treated Eczema Area Full Analysis Set
Description
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Change in Total Treated Eczema Area Per Protocol Analysis Set
Description
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Change in Area of Microbial Counting Site Full Analysis Set
Description
Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Change in Area of Microbial Counting Site Per Protocol Analysis Set
Description
Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Description
Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Description
Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Description
Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Description
Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Description
Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Description
Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Description
Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Description
Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame
Day 7, Day 14 and Day 21
Title
Investigator's Global Assessment of Eczema Change Full Analysis Set
Description
Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame
Day 7, Day 14 and Day 21
Title
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Description
Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame
Day 7, Day 14 and Day 21
Title
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
Description
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.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
Description
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.
Time Frame
Baseline, Day 7, Day 14 and Day 21
Title
Patient's Global Assessment of Eczema Change Full Analysis Set
Description
Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame
Day 7, Day 14 and Day 21
Title
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Description
Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame
Day 7, Day 14 and Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Quintiles Hermelinen AB
City
Luleå
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
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