A Randomized, Double-blinded Placebo-controlled Study to... | NCT01522391

ID	Type	Description	Link
2007-007103-32	EudraCT Number

Status Module

Description Module

Label	Type	Description	Intervention Names
Placebo for DPK-060 ointment	Placebo Comparator		Drug: Placebo for DPK-060 ointment
DPK-060 1% ointment	Experimental		Drug: DPK-060 1% ointment

Name	Type	Description	Arm Group Labels	Other Names
DPK-060 1% ointment	Drug	DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2	DPK-060 1% ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

Measure	Description	Time Frame
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
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set

Eligibility Module

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

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	DPK-060 1% Ointment

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	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.
BG001	DPK-060 1% Ointment	DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00121 BG00241

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00031.9± 14.6 BG00133.1± 13.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG00116 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Sweden

Title	Measurements
	BG00020 BG00121 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Median

Full Range

Percent change

Baseline and Day 14

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG00020 OG00121

Title

Denominators

Categories

Title	Measurements
	OG000-94(-100 to 19483) OG001-100(-100 to 40926)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		0.012		Ratio between geometric means	0.045			2-Sided	95	0.004	0.491					Other

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.

Per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Median

Full Range

Percent change

Baseline and Day 14

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Median

Full Range

Percent change

Baseline, Day 7 and 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Median

Full Range

Percent change

Baseline, Day 7 and 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Median

Full Range

Percent change

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Median

Full Range

Percent change

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Median

Full Range

Percent change

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Median

Full Range

Percent change

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Median

Full Range

Percent change

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Median

Full Range

Percent change

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

Secondary

Change in Total Treated Eczema Area Full Analysis Set

Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Mean

Standard Deviation

cm2

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Mean

Standard Deviation

cm2

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Mean

Standard Deviation

cm2

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Mean

Standard Deviation

cm2

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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)

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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)

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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.

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Mean

Standard Deviation

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants

Secondary

Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Mean

Standard Deviation

Baseline, Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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)

The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

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)

The per protocol analysis set is defined as the patients who completed the study according to the protocol.

Posted

Count of Participants

Participants

Day 7, Day 14 and Day 21

ID	Title	Description
OG000	Placebo for DPK-060 Ointment	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.
OG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo for DPK-060 Ointment	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			0	20	7	20
EG001	DPK-060 1% Ointment	DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2			0	21	10	21

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (8.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0013 affected21 at risk
Headache	Nervous system disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0012 affected21 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0003 affected20 at risk EG0010 affected21 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0004 affected20 at risk EG0014 affected21 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0000 affected20 at risk EG0012 affected21 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (8.1)	Non-systematic Assessment	EG0001 affected20 at risk EG0011 affected21 at risk

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations