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Trial record 26 of 452 for:    applied AND ointment

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01522391
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
DermaGen AB

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: DPK-060 1% ointment
Drug: Placebo for DPK-060 ointment
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2. DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Period Title: Overall Study
Started 20 21
Completed 19 20
Not Completed 1 1
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment Total
Hide Arm/Group Description Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2. DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2. Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
21
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
31.9  (14.6) 33.1  (13.5) 32.5  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
14
  70.0%
16
  76.2%
30
  73.2%
Male
6
  30.0%
5
  23.8%
11
  26.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 20 participants 21 participants 41 participants
20 21 41
1.Primary Outcome
Title Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set
Hide Description The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame Baseline and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Median (Full Range)
Unit of Measure: Percent change
-94
(-100 to 19483)
-100
(-100 to 40926)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.045
Confidence Interval (2-Sided) 95%
0.004 to 0.491
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set
Hide Description The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame Baseline and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Median (Full Range)
Unit of Measure: Percent change
-90
(-100 to 19483)
-100
(-100 to -52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.045
Confidence Interval (2-Sided) 95%
0.004 to 0.491
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set
Hide Description The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame Baseline, Day 7 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Median (Full Range)
Unit of Measure: Percent change
Day 7
-73
(-100 to 73429)
-98
(-100 to 40926)
Day 21
14
(-99 to 294067)
-37
(-100 to 40926)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.242
Confidence Interval (2-Sided) 95%
0.022 to 2.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.428
Confidence Interval (2-Sided) 95%
0.039 to 4.696
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set
Hide Description The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Time Frame Baseline, Day 7 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Median (Full Range)
Unit of Measure: Percent change
Day 7
-73
(-100 to 73429)
-96
(-100 to 563)
Day 21
20
(-99 to 294067)
-49
(-100 to 14344)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.242
Confidence Interval (2-Sided) 95%
0.022 to 2.660
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.428
Confidence Interval (2-Sided) 95%
0.039 to 4.696
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Hide Description The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Median (Full Range)
Unit of Measure: Percent change
Day 7
-50
(-100 to 73429)
-100
(-100 to 799900)
Day 14
-91
(-100 to 1665)
-100
(-100 to 799900)
Day 21
24
(-100 to 21900)
-2
(-100 to 799900)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.288
Confidence Interval (2-Sided) 95%
0.016 to 5.221
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.067
Confidence Interval (2-Sided) 95%
0.004 to 1.218
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.620
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.484
Confidence Interval (2-Sided) 95%
0.027 to 8.787
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Hide Description The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Median (Full Range)
Unit of Measure: Percent change
Day 7
-60
(-100 to 73429)
-100
(-100 to 546)
Day 14
-91
(-100 to 1665)
-100
(-100 to -77)
Day 21
24
(-100 to 21900)
-36
(-100 to 3614)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.287
Confidence Interval (2-Sided) 95%
0.015 to 5.550
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.032
Confidence Interval (2-Sided) 95%
0.002 to 0.583
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.271
Confidence Interval (2-Sided) 95%
0.015 to 4.779
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Hide Description The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Median (Full Range)
Unit of Measure: Percent change
Day 7
-99
(-100 to 93)
-100
(-100 to 353)
Day 14
-95
(-100 to 233)
-100
(-100 to -52)
Day 21
-82
(-100 to 1694)
-78
(-100 to 6844)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.970
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 1.045
Confidence Interval (2-Sided) 95%
0.106 to 10.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.045
Confidence Interval (2-Sided) 95%
0.005 to 0.447
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.360
Confidence Interval (2-Sided) 95%
0.036 to 3.556
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Hide Description The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Median (Full Range)
Unit of Measure: Percent change
Day 7
-99
(-100 to 93)
-98
(-100 to 353)
Day 14
-93
(-100 to 233)
-100
(-100 to -52)
Day 21
-82
(-100 to 1694)
-73
(-100 to 6844)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.974
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.961
Confidence Interval (2-Sided) 95%
0.081 to 11.43
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.046
Confidence Interval (2-Sided) 95%
0.004 to 0.512
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.504
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.447
Confidence Interval (2-Sided) 95%
0.041 to 4.883
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Hide Description The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Median (Full Range)
Unit of Measure: Percent change
Day 7
-73
(-100 to 73429)
-98
(-100 to 40926)
Day 14
-94
(-100 to 19483)
-100
(-100 to 40926)
Day 21
14
(-99 to 291567)
-37
(-100 to 40926)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.242
Confidence Interval (2-Sided) 95%
0.022 to 2.659
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.045
Confidence Interval (2-Sided) 95%
0.004 to 0.491
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.428
Confidence Interval (2-Sided) 95%
0.039 to 4.697
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Hide Description The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Median (Full Range)
Unit of Measure: Percent change
Day 7
-73
(-100 to 73429)
-96
(-100 to 563)
Day 14
-90
(-100 to 19483)
-100
(-100 to -52)
Day 21
20
(-99 to 291567)
-49
(-100 to 14344)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.202
Confidence Interval (2-Sided) 95%
0.017 to 2.340
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.021
Confidence Interval (2-Sided) 95%
0.002 to 0.227
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio between geometric means
Estimated Value 0.257
Confidence Interval (2-Sided) 95%
0.024 to 2.752
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Total Treated Eczema Area Full Analysis Set
Hide Description Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: cm2
Day 7 12.0  (32.8) 32.3  (92.2)
Day 14 -15.0  (42.9) 14.1  (82.7)
Day 21 17.4  (78.7) 5.8  (60.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 20.38
Confidence Interval (2-Sided) 95%
-22.42 to 63.19
Estimation Comments [Not Specified]
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Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 29.10
Confidence Interval (2-Sided) 95%
-13.71 to 71.90
Estimation Comments [Not Specified]
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Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.590
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -11.64
Confidence Interval (2-Sided) 95%
-54.44 to 31.16
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Total Treated Eczema Area Per Protocol Analysis Set
Hide Description Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: cm2
Day 7 12.1  (33.7) 18.0  (66.4)
Day 14 -16.0  (44.9) -1.2  (45.4)
Day 21 21.1  (82.4) 2.4  (60.3)
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Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.748
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 5.95
Confidence Interval (2-Sided) 95%
-30.84 to 42.73
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.437
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 14.62
Confidence Interval (2-Sided) 95%
-22.65 to 51.88
Estimation Comments [Not Specified]
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Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -18.66
Confidence Interval (2-Sided) 95%
-55.92 to 18.61
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Area of Microbial Counting Site Full Analysis Set
Hide Description Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: cm2
Day 7 12.1  (25.5) 20.1  (68.0)
Day 14 -16.3  (32.2) 4.2  (49.1)
Day 21 8.9  (66.0) 7.6  (62.3)
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Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.631
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 8.04
Confidence Interval (2-Sided) 95%
-25.15 to 41.24
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 20.44
Confidence Interval (2-Sided) 95%
-12.75 to 53.63
Estimation Comments [Not Specified]
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Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.941
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -1.23
Confidence Interval (2-Sided) 95%
-34.42 to 31.96
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in Area of Microbial Counting Site Per Protocol Analysis Set
Hide Description Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: cm2
Day 7 13.3  (26.7) 15.3  (66.0)
Day 14 -18.2  (33.4) -1.5  (42.8)
Day 21 9.8  (69.7) 2.2  (58.5)
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Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
-32.93 to 34.87
Estimation Comments [Not Specified]
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Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 15.72
Confidence Interval (2-Sided) 95%
-18.18 to 49.62
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least Square Mean Difference
Estimated Value -7.94
Confidence Interval (2-Sided) 95%
-41.82 to 25.94
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Hide Description Evaluation of erythema on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 0 0
Slight 11 13
Moderate 8 7
Severe 1 1
Day 14 No symptoms 0 0
Slight 11 11
Moderate 8 9
Severe 1 1
Day 21 No symptoms 0 0
Slight 10 14
Moderate 8 6
Severe 2 1
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Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
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Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.898
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
16.Secondary Outcome
Title Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Hide Description Evaluation of erythema on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 0 0
Slight 10 13
Moderate 8 6
Severe 1 1
Missing 0 0
Day 14 No symptoms 0 0
Slight 9 11
Moderate 8 8
Severe 1 1
Missing 1 0
Day 21 No symptoms 0 0
Slight 8 13
Moderate 8 6
Severe 2 1
Missing 1 0
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Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.511
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.777
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
17.Secondary Outcome
Title Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Hide Description Evaluation of excoriations on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 5 6
Slight 7 10
Moderate 6 3
Severe 2 2
Day 14 No symptoms 6 9
Slight 7 8
Moderate 7 4
Severe 0 0
Day 21 No symptoms 5 8
Slight 6 9
Moderate 8 4
Severe 1 0
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Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.489
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
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Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
18.Secondary Outcome
Title Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Hide Description Evaluation of excoriations on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 4 6
Slight 7 10
Moderate 6 2
Severe 2 2
Missing 0 0
Day 14 No symptoms 5 9
Slight 6 8
Moderate 7 3
Severe 0 0
Missing 1 0
Day 21 No symptoms 3 8
Slight 6 8
Moderate 8 4
Severe 1 0
Missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.291
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
19.Secondary Outcome
Title Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Hide Description Evaluation of infiltration on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 4 4
Slight 13 12
Moderate 2 5
Severe 1 0
Day 14 No symptoms 5 5
Slight 9 11
Moderate 6 5
Severe 0 0
Day 21 No symptoms 5 7
Slight 7 9
Moderate 6 5
Severe 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
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Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
20.Secondary Outcome
Title Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Hide Description Evaluation of infiltration on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 4 4
Slight 12 11
Moderate 2 5
Severe 1 0
Missing 0 0
Day 14 No symptoms 5 5
Slight 7 10
Moderate 6 5
Severe 0 0
Missing 1 0
Day 21 No symptoms 3 7
Slight 7 8
Moderate 6 5
Severe 2 0
Missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
21.Secondary Outcome
Title Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Hide Description Evaluation of lichenification on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 0 3
Slight 14 12
Moderate 6 6
Severe 0 0
Day 14 No symptoms 4 4
Slight 9 10
Moderate 7 7
Severe 0 0
Day 21 No symptoms 4 1
Slight 8 15
Moderate 8 5
Severe 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
22.Secondary Outcome
Title Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Hide Description Evaluation of lichenification on a scale 0–3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 No symptoms 0 3
Slight 13 11
Moderate 6 6
Severe 0 0
Missing 0 0
Day 14 No symptoms 4 4
Slight 7 9
Moderate 7 7
Severe 0 0
Missing 1 0
Day 21 No symptoms 2 1
Slight 8 14
Moderate 8 5
Severe 0 0
Missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.946
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
23.Secondary Outcome
Title Investigator’s Global Assessment of Eczema Change Full Analysis Set
Hide Description Investigator’s global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Worse 4 4
Unchanged 8 6
Improved 8 11
Day 14 Worse 5 3
Unchanged 4 9
Improved 11 9
Day 21 Worse 10 5
Unchanged 6 10
Improved 4 6
24.Secondary Outcome
Title Investigator’s Global Assessment of Eczema Change Per Protocol Analysis Set
Hide Description Investigator’s global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Worse 4 3
Unchanged 7 6
Improved 8 11
Missing 0 0
Day 14 Worse 5 2
Unchanged 3 9
Improved 10 9
Missing 1 0
Day 21 Worse 10 5
Unchanged 6 9
Improved 2 6
Missing 1 0
25.Secondary Outcome
Title Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
Hide Description The Visual Analog Scale of Itching (VASI), is the patient’s assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: mm
Day 7 -11.19  (26.19) -15.19  (27.23)
Day 14 -15.34  (21.28) -10.60  (25.97)
Day 21 -4.34  (28.66) -13.41  (27.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7 morning
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.477
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14 morning
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.651
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21 morning
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
Hide Description The Visual Analog Scale of Itching (VASI), is the patient’s assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.
Time Frame Baseline, Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: mm
Day 7 -11.32  (26.90) -20.48  (18.72)
Day 14 -16.91  (24.25) -14.92  (18.37)
Day 21 -2.24  (29.44) -12.89  (28.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 7 morning
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 14
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo for DPK-060 Ointment, DPK-060 1% Ointment
Comments Day 21
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Secondary Outcome
Title Patient’s Global Assessment of Eczema Change Full Analysis Set
Hide Description Patient’s global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Worse 1 2
Unchanged 14 14
Improved 5 5
Day 14 morning Worse 0 2
Unchanged 13 13
Improved 7 6
Day 21 Worse 7 5
Unchanged 9 8
Improved 4 8
28.Secondary Outcome
Title Patient’s Global Assessment of Eczema Change Per Protocol Analysis Set
Hide Description Patient’s global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Time Frame Day 7, Day 14 and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description:
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.
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Worse 1 0
Unchanged 14 13
Improved 4 5
Missing 0 2
Day 14 morning Worse 0 1
Unchanged 9 12
Improved 5 5
Missing 5 2
Day 21 Worse 7 5
Unchanged 8 8
Improved 2 7
Missing 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo for DPK-060 Ointment DPK-060 1% Ointment
Hide Arm/Group Description 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 DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
All-Cause Mortality
Placebo for DPK-060 Ointment DPK-060 1% Ointment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo for DPK-060 Ointment DPK-060 1% Ointment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo for DPK-060 Ointment DPK-060 1% Ointment
Affected / at Risk (%) Affected / at Risk (%)
Total   7/20 (35.00%)   10/21 (47.62%) 
Infections and infestations     
Nasopharyngitis * 1  0/20 (0.00%)  3/21 (14.29%) 
Nervous system disorders     
Headache * 1  1/20 (5.00%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  0/20 (0.00%)  2/21 (9.52%) 
Pain of skin * 1  3/20 (15.00%)  0/21 (0.00%) 
Pruritus * 1  4/20 (20.00%)  4/21 (19.05%) 
Skin burning sensation * 1  0/20 (0.00%)  2/21 (9.52%) 
Urticaria * 1  1/20 (5.00%)  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Margit Mahlapuu PhD, Assoc. Prof. in Molecular Medicine
Organization: Pergamum AB
Phone: +46 70 631 01 09
Responsible Party: DermaGen AB
ClinicalTrials.gov Identifier: NCT01522391     History of Changes
Other Study ID Numbers: DCS-001
2007-007103-32 ( EudraCT Number )
First Submitted: January 20, 2012
First Posted: January 31, 2012
Results First Submitted: April 27, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018