Atopic Dermatitis
Conditions
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.
Interventions
DRUGDPK-060 1% ointment
DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
DRUGPlacebo for DPK-060 ointment
Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
Sponsors
DermaGen AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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) 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 |
| 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 |
| 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 |
| 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 |
| 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 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. |
| 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) |
| 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 |
| 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) |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| DPK-060 1% Ointment DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | DPK-060 1% Ointment | Placebo for DPK-060 Ointment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 20 Participants | 41 Participants |
| Age, Continuous | 33.1 years STANDARD_DEVIATION 13.5 | 31.9 years STANDARD_DEVIATION 14.6 | 32.5 years STANDARD_DEVIATION 13.9 |
| Region of Enrollment Sweden | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 20 | 10 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
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.
Time frame: Baseline and Day 14
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set | -94 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set | -100 Percent change |
p-value: 0.01295% CI: [0.004, 0.491]Mixed Models Analysis
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.
Time frame: Baseline and Day 14
Population: Per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set | -90 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set | -100 Percent change |
p-value: 0.01295% CI: [0.004, 0.491]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set | Day 7 | -11.19 mm | Standard Deviation 26.19 |
| Placebo for DPK-060 Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set | Day 14 | -15.34 mm | Standard Deviation 21.28 |
| Placebo for DPK-060 Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set | Day 21 | -4.34 mm | Standard Deviation 28.66 |
| DPK-060 1% Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set | Day 7 | -15.19 mm | Standard Deviation 27.23 |
| DPK-060 1% Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set | Day 14 | -10.60 mm | Standard Deviation 25.97 |
| DPK-060 1% Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set | Day 21 | -13.41 mm | Standard Deviation 27.72 |
Comparison: Day 7 morningp-value: 0.477Wilcoxon (Mann-Whitney)
Comparison: Day 14 morningp-value: 0.651Wilcoxon (Mann-Whitney)
Comparison: Day 21 morningp-value: 0.34Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set | Day 7 | -11.32 mm | Standard Deviation 26.9 |
| Placebo for DPK-060 Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set | Day 14 | -16.91 mm | Standard Deviation 24.25 |
| Placebo for DPK-060 Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set | Day 21 | -2.24 mm | Standard Deviation 29.44 |
| DPK-060 1% Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set | Day 7 | -20.48 mm | Standard Deviation 18.72 |
| DPK-060 1% Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set | Day 14 | -14.92 mm | Standard Deviation 18.37 |
| DPK-060 1% Ointment | Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set | Day 21 | -12.89 mm | Standard Deviation 28.34 |
Comparison: Day 7 morningp-value: 0.3Wilcoxon (Mann-Whitney)
Comparison: Day 14p-value: 0.705Wilcoxon (Mann-Whitney)
Comparison: Day 21p-value: 0.286Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Change in Area of Microbial Counting Site Full Analysis Set | Day 7 | 12.1 cm2 | Standard Deviation 25.5 |
| Placebo for DPK-060 Ointment | Change in Area of Microbial Counting Site Full Analysis Set | Day 14 | -16.3 cm2 | Standard Deviation 32.2 |
| Placebo for DPK-060 Ointment | Change in Area of Microbial Counting Site Full Analysis Set | Day 21 | 8.9 cm2 | Standard Deviation 66 |
| DPK-060 1% Ointment | Change in Area of Microbial Counting Site Full Analysis Set | Day 7 | 20.1 cm2 | Standard Deviation 68 |
| DPK-060 1% Ointment | Change in Area of Microbial Counting Site Full Analysis Set | Day 14 | 4.2 cm2 | Standard Deviation 49.1 |
| DPK-060 1% Ointment | Change in Area of Microbial Counting Site Full Analysis Set | Day 21 | 7.6 cm2 | Standard Deviation 62.3 |
Comparison: Day 7p-value: 0.63195% CI: [-25.15, 41.24]Mixed Models Analysis
Comparison: Day 14p-value: 0.22495% CI: [-12.75, 53.63]Mixed Models Analysis
Comparison: Day 21p-value: 0.94195% CI: [-34.42, 31.96]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Change in Area of Microbial Counting Site Per Protocol Analysis Set | Day 7 | 13.3 cm2 | Standard Deviation 26.7 |
| Placebo for DPK-060 Ointment | Change in Area of Microbial Counting Site Per Protocol Analysis Set | Day 14 | -18.2 cm2 | Standard Deviation 33.4 |
| Placebo for DPK-060 Ointment | Change in Area of Microbial Counting Site Per Protocol Analysis Set | Day 21 | 9.8 cm2 | Standard Deviation 69.7 |
| DPK-060 1% Ointment | Change in Area of Microbial Counting Site Per Protocol Analysis Set | Day 7 | 15.3 cm2 | Standard Deviation 66 |
| DPK-060 1% Ointment | Change in Area of Microbial Counting Site Per Protocol Analysis Set | Day 14 | -1.5 cm2 | Standard Deviation 42.8 |
| DPK-060 1% Ointment | Change in Area of Microbial Counting Site Per Protocol Analysis Set | Day 21 | 2.2 cm2 | Standard Deviation 58.5 |
Comparison: Day 7p-value: 0.95495% CI: [-32.93, 34.87]Mixed Models Analysis
Comparison: Day 14p-value: 0.35895% CI: [-18.18, 49.62]Mixed Models Analysis
Comparison: Day 21p-value: 0.64295% CI: [-41.82, 25.94]Mixed Models Analysis
Secondary
Change in Total Treated Eczema Area Full Analysis Set
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Change in Total Treated Eczema Area Full Analysis Set | Day 7 | 12.0 cm2 | Standard Deviation 32.8 |
| Placebo for DPK-060 Ointment | Change in Total Treated Eczema Area Full Analysis Set | Day 14 | -15.0 cm2 | Standard Deviation 42.9 |
| Placebo for DPK-060 Ointment | Change in Total Treated Eczema Area Full Analysis Set | Day 21 | 17.4 cm2 | Standard Deviation 78.7 |
| DPK-060 1% Ointment | Change in Total Treated Eczema Area Full Analysis Set | Day 14 | 14.1 cm2 | Standard Deviation 82.7 |
| DPK-060 1% Ointment | Change in Total Treated Eczema Area Full Analysis Set | Day 7 | 32.3 cm2 | Standard Deviation 92.2 |
| DPK-060 1% Ointment | Change in Total Treated Eczema Area Full Analysis Set | Day 21 | 5.8 cm2 | Standard Deviation 60.8 |
Comparison: Day 7p-value: 0.34695% CI: [-22.42, 63.19]Mixed Models Analysis
Comparison: Day 14p-value: 0.1895% CI: [-13.71, 71.9]Mixed Models Analysis
Comparison: Day 21p-value: 0.5995% CI: [-54.44, 31.16]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Change in Total Treated Eczema Area Per Protocol Analysis Set | Day 7 | 12.1 cm2 | Standard Deviation 33.7 |
| Placebo for DPK-060 Ointment | Change in Total Treated Eczema Area Per Protocol Analysis Set | Day 14 | -16.0 cm2 | Standard Deviation 44.9 |
| Placebo for DPK-060 Ointment | Change in Total Treated Eczema Area Per Protocol Analysis Set | Day 21 | 21.1 cm2 | Standard Deviation 82.4 |
| DPK-060 1% Ointment | Change in Total Treated Eczema Area Per Protocol Analysis Set | Day 7 | 18.0 cm2 | Standard Deviation 66.4 |
| DPK-060 1% Ointment | Change in Total Treated Eczema Area Per Protocol Analysis Set | Day 14 | -1.2 cm2 | Standard Deviation 45.4 |
| DPK-060 1% Ointment | Change in Total Treated Eczema Area Per Protocol Analysis Set | Day 21 | 2.4 cm2 | Standard Deviation 60.3 |
Comparison: Day 7p-value: 0.74895% CI: [-30.84, 42.73]Mixed Models Analysis
Comparison: Day 14p-value: 0.43795% CI: [-22.65, 51.88]Mixed Models Analysis
Comparison: Day 21p-value: 0.32295% CI: [-55.92, 18.61]Mixed Models Analysis
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
Time frame: Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 0 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 11 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 0 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 11 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 0 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 10 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 2 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 6 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 9 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 13 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 14 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 7 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 1 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 1 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 1 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 11 Participants |
Comparison: Day 7p-value: 0.701Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.898Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.271Cochran-Mantel-Haenszel
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
Time frame: Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 10 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 0 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 0 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 9 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 2 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 13 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 6 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 1 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 11 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 8 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 1 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 13 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 6 Participants |
| DPK-060 1% Ointment | Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 1 Participants |
Comparison: Day 7p-value: 0.511Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.777Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.204Cochran-Mantel-Haenszel
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
Time frame: Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 5 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 2 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 6 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 7 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 5 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 6 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 1 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 4 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 6 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 4 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 10 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 9 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 3 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 0 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 2 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 0 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 9 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 8 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 8 Participants |
Comparison: Day 7p-value: 0.489Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.249Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.098Cochran-Mantel-Haenszel
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
Time frame: Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 5 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 3 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 2 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 6 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 6 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 7 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 4 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 0 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 6 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 10 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 2 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 2 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 9 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 8 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 3 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 0 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 0 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 8 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 8 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 4 Participants |
| DPK-060 1% Ointment | Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 0 Participants |
Comparison: Day 7p-value: 0.291Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.113Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.033Cochran-Mantel-Haenszel
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
Time frame: Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 4 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 13 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 2 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 5 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 9 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 5 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 2 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 4 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 12 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 9 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 7 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 11 Participants |
Comparison: Day 7p-value: 0.825Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.825Cochran-Mantel-Haenszel
p-value: 0.208Cochran-Mantel-Haenszel
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
Time frame: Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 12 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 5 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 3 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 1 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 2 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 2 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 4 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 4 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 11 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 10 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 0 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 7 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 8 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 0 Participants |
Comparison: Day 7p-value: 0.825Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.82Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.086Cochran-Mantel-Haenszel
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)
Time frame: Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Unchanged | 8 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 14 | Improved | 11 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 14 | Worse | 5 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Worse | 10 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Improved | 8 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Unchanged | 6 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 14 | Unchanged | 4 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Improved | 4 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Worse | 4 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Improved | 6 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Worse | 4 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Unchanged | 6 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Improved | 11 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 14 | Worse | 3 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 14 | Unchanged | 9 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 14 | Improved | 9 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Worse | 5 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Unchanged | 10 Participants |
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)
Time frame: Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Worse | 4 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Unchanged | 7 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Improved | 8 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Worse | 5 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Unchanged | 3 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Improved | 10 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Worse | 10 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Unchanged | 6 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Improved | 2 Participants |
| Placebo for DPK-060 Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Missing | 1 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Improved | 6 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Worse | 3 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Improved | 9 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Unchanged | 6 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Unchanged | 9 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Improved | 11 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Missing | 0 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Missing | 0 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Worse | 2 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Worse | 5 Participants |
| DPK-060 1% Ointment | Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 | Unchanged | 9 Participants |
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
Time frame: Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 14 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 4 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 9 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 7 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 4 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 8 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | No symptoms | 3 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Moderate | 7 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Slight | 12 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Slight | 15 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Moderate | 6 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Severe | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 7 | Severe | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | Severe | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | No symptoms | 4 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 21 | No symptoms | 1 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set | Day 14 | Slight | 10 Participants |
Comparison: Day 7p-value: 0.378Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.975Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.962Cochran-Mantel-Haenszel
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
Time frame: Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 13 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 4 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 2 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 8 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 7 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 8 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 6 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 0 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 7 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 1 Participants |
| Placebo for DPK-060 Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Missing | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | No symptoms | 3 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Slight | 11 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Moderate | 6 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Severe | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | No symptoms | 4 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Slight | 9 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Moderate | 7 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Severe | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 14 | Missing | 0 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | No symptoms | 1 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Slight | 14 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Moderate | 5 Participants |
| DPK-060 1% Ointment | Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set | Day 21 | Severe | 0 Participants |
Comparison: Day 7p-value: 0.375Cochran-Mantel-Haenszel
Comparison: Day 14p-value: 0.946Cochran-Mantel-Haenszel
Comparison: Day 21p-value: 0.495Cochran-Mantel-Haenszel
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)
Time frame: Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Unchanged | 14 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 14 morning | Improved | 7 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 14 morning | Worse | 0 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Worse | 7 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Improved | 5 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Unchanged | 9 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 14 morning | Unchanged | 13 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Improved | 4 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Worse | 1 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Improved | 8 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Worse | 2 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Unchanged | 14 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 7 | Improved | 5 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 14 morning | Worse | 2 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 14 morning | Unchanged | 13 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 14 morning | Improved | 6 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Worse | 5 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Full Analysis Set | Day 21 | Unchanged | 8 Participants |
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)
Time frame: Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Worse | 1 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Unchanged | 14 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Improved | 4 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Missing | 0 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Worse | 0 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Unchanged | 9 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Improved | 5 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Missing | 5 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Worse | 7 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Unchanged | 8 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Improved | 2 Participants |
| Placebo for DPK-060 Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Missing | 2 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Improved | 7 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Worse | 0 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Improved | 5 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Unchanged | 13 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Unchanged | 8 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Improved | 5 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Missing | 2 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 7 | Missing | 2 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Missing | 0 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Worse | 1 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 21 | Worse | 5 Participants |
| DPK-060 1% Ointment | Patient's Global Assessment of Eczema Change Per Protocol Analysis Set | Day 14 morning | Unchanged | 12 Participants |
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 7 | -73 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 14 | -94 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 21 | 14 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 7 | -98 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 14 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 21 | -37 Percent change |
Comparison: Day 7p-value: 0.24295% CI: [0.022, 2.659]Mixed Models Analysis
Comparison: Day 14p-value: 0.01295% CI: [0.004, 0.491]Mixed Models Analysis
Comparison: Day 21p-value: 0.48395% CI: [0.039, 4.697]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 7 | -73 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 14 | -90 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 21 | 20 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 7 | -96 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 14 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 21 | -49 Percent change |
Comparison: Day 7p-value: 0.19795% CI: [0.017, 2.34]Mixed Models Analysis
Comparison: Day 14p-value: 0.00295% CI: [0.002, 0.227]Mixed Models Analysis
Comparison: Day 21p-value: 0.25795% CI: [0.024, 2.752]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 7 | -99 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 14 | -95 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 21 | -82 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 7 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 14 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 21 | -78 Percent change |
Comparison: Day 7p-value: 0.9795% CI: [0.106, 10.32]Mixed Models Analysis
Comparison: Day 14p-value: 0.00995% CI: [0.005, 0.447]Mixed Models Analysis
Comparison: Day 21p-value: 0.37795% CI: [0.036, 3.556]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 7 | -99 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 14 | -93 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 21 | -82 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 7 | -98 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 14 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 21 | -73 Percent change |
Comparison: Day 7p-value: 0.97495% CI: [0.081, 11.43]Mixed Models Analysis
Comparison: Day 14p-value: 0.01395% CI: [0.004, 0.512]Mixed Models Analysis
Comparison: Day 21p-value: 0.50495% CI: [0.041, 4.883]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 7 | -50 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 14 | -91 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 21 | 24 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 7 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 14 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set | Day 21 | -2 Percent change |
Comparison: Day 7p-value: 0.39595% CI: [0.016, 5.221]Mixed Models Analysis
Comparison: Day 14p-value: 0.06795% CI: [0.004, 1.218]Mixed Models Analysis
Comparison: Day 21p-value: 0.6295% CI: [0.027, 8.787]Mixed Models Analysis
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.
Time frame: Baseline, Day 7, Day 14 and Day 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 7 | -60 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 14 | -91 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 21 | 24 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 7 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 14 | -100 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set | Day 21 | -36 Percent change |
Comparison: Day 7p-value: 0.40395% CI: [0.015, 5.55]Mixed Models Analysis
Comparison: Day 14p-value: 0.02195% CI: [0.002, 0.583]Mixed Models Analysis
Comparison: Day 21p-value: 0.36895% CI: [0.015, 4.779]Mixed Models Analysis
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.
Time frame: Baseline, Day 7 and 21
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set | Day 7 | -73 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set | Day 21 | 14 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set | Day 7 | -98 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set | Day 21 | -37 Percent change |
Comparison: Day 7p-value: 0.24295% CI: [0.022, 2.66]Mixed Models Analysis
Comparison: Day 21p-value: 0.48295% CI: [0.039, 4.696]Mixed Models Analysis
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.
Time frame: Baseline, Day 7 and 21
Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set | Day 7 | -73 Percent change |
| Placebo for DPK-060 Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set | Day 21 | 20 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set | Day 7 | -96 Percent change |
| DPK-060 1% Ointment | Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set | Day 21 | -49 Percent change |
Comparison: Day 7p-value: 0.24295% CI: [0.022, 2.66]Mixed Models Analysis
Comparison: Day 21p-value: 0.48295% CI: [0.039, 4.696]Mixed Models Analysis