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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522391
• Other study ID #: DCS-001
• Secondary ID: 2007-007103-32
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2018
• Source: DermaGen AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• DPK-060 1% ointment
DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
• 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

Locations

Country	Name	City	State
Sweden	Quintiles Hermelinen AB	Luleå

Sponsors (1)

Lead Sponsor	Collaborator
DermaGen AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Day 14
Primary	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.	Baseline and Day 14
Secondary	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.	Baseline, Day 7 and 21
Secondary	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.	Baseline, Day 7 and 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	Change in Total Treated Eczema Area Full Analysis Set	Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.	Baseline, Day 7, Day 14 and Day 21
Secondary	Change in Total Treated Eczema Area Per Protocol Analysis Set	Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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	Day 7, Day 14 and Day 21
Secondary	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)	Day 7, Day 14 and Day 21
Secondary	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)	Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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.	Baseline, Day 7, Day 14 and Day 21
Secondary	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)	Day 7, Day 14 and Day 21
Secondary	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)	Day 7, Day 14 and Day 21