Trial Outcomes & Findings for A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060 (NCT NCT01522391)
NCT ID: NCT01522391
Last Updated: 2018-12-05
Results Overview
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline and Day 14
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
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 Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
Baseline characteristics by cohort
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
DPK-060 1% Ointment
n=21 Participants
DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 14Population: 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.
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set
|
-94 Percent change
Interval -100.0 to 19483.0
|
-100 Percent change
Interval -100.0 to 40926.0
|
PRIMARY outcome
Timeframe: Baseline and Day 14Population: Per protocol analysis set is defined as the patients who completed the study according to the protocol.
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set
|
-90 Percent change
Interval -100.0 to 19483.0
|
-100 Percent change
Interval -100.0 to -52.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7 and 21Population: 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.
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
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
Interval -100.0 to 73429.0
|
-98 Percent change
Interval -100.0 to 40926.0
|
|
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
Interval -99.0 to 294067.0
|
-37 Percent change
Interval -100.0 to 40926.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7 and 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
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
Interval -100.0 to 73429.0
|
-96 Percent change
Interval -100.0 to 563.0
|
|
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
Interval -99.0 to 294067.0
|
-49 Percent change
Interval -100.0 to 14344.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: 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.
The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 7
|
-50 Percent change
Interval -100.0 to 73429.0
|
-100 Percent change
Interval -100.0 to 799900.0
|
|
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 14
|
-91 Percent change
Interval -100.0 to 1665.0
|
-100 Percent change
Interval -100.0 to 799900.0
|
|
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 21
|
24 Percent change
Interval -100.0 to 21900.0
|
-2 Percent change
Interval -100.0 to 799900.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Day 7
|
-60 Percent change
Interval -100.0 to 73429.0
|
-100 Percent change
Interval -100.0 to 546.0
|
|
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Day 14
|
-91 Percent change
Interval -100.0 to 1665.0
|
-100 Percent change
Interval -100.0 to -77.0
|
|
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Day 21
|
24 Percent change
Interval -100.0 to 21900.0
|
-36 Percent change
Interval -100.0 to 3614.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: 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.
The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 7
|
-99 Percent change
Interval -100.0 to 93.0
|
-100 Percent change
Interval -100.0 to 353.0
|
|
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 14
|
-95 Percent change
Interval -100.0 to 233.0
|
-100 Percent change
Interval -100.0 to -52.0
|
|
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 21
|
-82 Percent change
Interval -100.0 to 1694.0
|
-78 Percent change
Interval -100.0 to 6844.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Day 7
|
-99 Percent change
Interval -100.0 to 93.0
|
-98 Percent change
Interval -100.0 to 353.0
|
|
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Day 14
|
-93 Percent change
Interval -100.0 to 233.0
|
-100 Percent change
Interval -100.0 to -52.0
|
|
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Day 21
|
-82 Percent change
Interval -100.0 to 1694.0
|
-73 Percent change
Interval -100.0 to 6844.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: 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.
The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 7
|
-73 Percent change
Interval -100.0 to 73429.0
|
-98 Percent change
Interval -100.0 to 40926.0
|
|
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 14
|
-94 Percent change
Interval -100.0 to 19483.0
|
-100 Percent change
Interval -100.0 to 40926.0
|
|
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Day 21
|
14 Percent change
Interval -99.0 to 291567.0
|
-37 Percent change
Interval -100.0 to 40926.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
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
Interval -100.0 to 73429.0
|
-96 Percent change
Interval -100.0 to 563.0
|
|
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
Interval -100.0 to 19483.0
|
-100 Percent change
Interval -100.0 to -52.0
|
|
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
Interval -99.0 to 291567.0
|
-49 Percent change
Interval -100.0 to 14344.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: 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.
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Change in Total Treated Eczema Area Full Analysis Set
Day 7
|
12.0 cm2
Standard Deviation 32.8
|
32.3 cm2
Standard Deviation 92.2
|
|
Change in Total Treated Eczema Area Full Analysis Set
Day 14
|
-15.0 cm2
Standard Deviation 42.9
|
14.1 cm2
Standard Deviation 82.7
|
|
Change in Total Treated Eczema Area Full Analysis Set
Day 21
|
17.4 cm2
Standard Deviation 78.7
|
5.8 cm2
Standard Deviation 60.8
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Change in Total Treated Eczema Area Per Protocol Analysis Set
Day 7
|
12.1 cm2
Standard Deviation 33.7
|
18.0 cm2
Standard Deviation 66.4
|
|
Change in Total Treated Eczema Area Per Protocol Analysis Set
Day 14
|
-16.0 cm2
Standard Deviation 44.9
|
-1.2 cm2
Standard Deviation 45.4
|
|
Change in Total Treated Eczema Area Per Protocol Analysis Set
Day 21
|
21.1 cm2
Standard Deviation 82.4
|
2.4 cm2
Standard Deviation 60.3
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: 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.
Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Change in Area of Microbial Counting Site Full Analysis Set
Day 7
|
12.1 cm2
Standard Deviation 25.5
|
20.1 cm2
Standard Deviation 68.0
|
|
Change in Area of Microbial Counting Site Full Analysis Set
Day 14
|
-16.3 cm2
Standard Deviation 32.2
|
4.2 cm2
Standard Deviation 49.1
|
|
Change in Area of Microbial Counting Site Full Analysis Set
Day 21
|
8.9 cm2
Standard Deviation 66.0
|
7.6 cm2
Standard Deviation 62.3
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Change in Area of Microbial Counting Site Per Protocol Analysis Set
Day 7
|
13.3 cm2
Standard Deviation 26.7
|
15.3 cm2
Standard Deviation 66.0
|
|
Change in Area of Microbial Counting Site Per Protocol Analysis Set
Day 14
|
-18.2 cm2
Standard Deviation 33.4
|
-1.5 cm2
Standard Deviation 42.8
|
|
Change in Area of Microbial Counting Site Per Protocol Analysis Set
Day 21
|
9.8 cm2
Standard Deviation 69.7
|
2.2 cm2
Standard Deviation 58.5
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: 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.
Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · No symptoms
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Slight
|
11 Participants
|
13 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Moderate
|
8 Participants
|
7 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Severe
|
1 Participants
|
1 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · No symptoms
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Slight
|
11 Participants
|
11 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Moderate
|
8 Participants
|
9 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Severe
|
1 Participants
|
1 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · No symptoms
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Slight
|
10 Participants
|
14 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Moderate
|
8 Participants
|
6 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Severe
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · No symptoms
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Slight
|
10 Participants
|
13 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Moderate
|
8 Participants
|
6 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Severe
|
1 Participants
|
1 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Missing
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · No symptoms
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Slight
|
9 Participants
|
11 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Moderate
|
8 Participants
|
8 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Severe
|
1 Participants
|
1 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Missing
|
1 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · No symptoms
|
0 Participants
|
0 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Slight
|
8 Participants
|
13 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Moderate
|
8 Participants
|
6 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Severe
|
2 Participants
|
1 Participants
|
|
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: 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.
Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Slight
|
7 Participants
|
8 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Moderate
|
7 Participants
|
4 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · No symptoms
|
5 Participants
|
6 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Slight
|
7 Participants
|
10 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Moderate
|
6 Participants
|
3 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Severe
|
2 Participants
|
2 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · No symptoms
|
6 Participants
|
9 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · No symptoms
|
5 Participants
|
8 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Slight
|
6 Participants
|
9 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Moderate
|
8 Participants
|
4 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Severe
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · No symptoms
|
4 Participants
|
6 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Slight
|
7 Participants
|
10 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Moderate
|
6 Participants
|
2 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Severe
|
2 Participants
|
2 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Missing
|
0 Participants
|
0 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · No symptoms
|
5 Participants
|
9 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Slight
|
6 Participants
|
8 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Moderate
|
7 Participants
|
3 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Missing
|
1 Participants
|
0 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · No symptoms
|
3 Participants
|
8 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Slight
|
6 Participants
|
8 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Moderate
|
8 Participants
|
4 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Severe
|
1 Participants
|
0 Participants
|
|
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: 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.
Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · No symptoms
|
4 Participants
|
4 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Slight
|
13 Participants
|
12 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Moderate
|
2 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Severe
|
1 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · No symptoms
|
5 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Slight
|
9 Participants
|
11 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Moderate
|
6 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · No symptoms
|
5 Participants
|
7 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Slight
|
7 Participants
|
9 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Moderate
|
6 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Severe
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · No symptoms
|
4 Participants
|
4 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Slight
|
12 Participants
|
11 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Moderate
|
2 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Severe
|
1 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Missing
|
0 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · No symptoms
|
5 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Slight
|
7 Participants
|
10 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Moderate
|
6 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Missing
|
1 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · No symptoms
|
3 Participants
|
7 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Slight
|
7 Participants
|
8 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Moderate
|
6 Participants
|
5 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Severe
|
2 Participants
|
0 Participants
|
|
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: 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.
Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · No symptoms
|
0 Participants
|
3 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Slight
|
14 Participants
|
12 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Moderate
|
6 Participants
|
6 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 7 · Severe
|
0 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · No symptoms
|
4 Participants
|
4 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Slight
|
9 Participants
|
10 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Moderate
|
7 Participants
|
7 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Slight
|
8 Participants
|
15 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · No symptoms
|
4 Participants
|
1 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Moderate
|
8 Participants
|
5 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Day 21 · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · No symptoms
|
0 Participants
|
3 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Slight
|
13 Participants
|
11 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Moderate
|
6 Participants
|
6 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Severe
|
0 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 7 · Missing
|
0 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · No symptoms
|
4 Participants
|
4 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Slight
|
7 Participants
|
9 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Moderate
|
7 Participants
|
7 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Severe
|
0 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 14 · Missing
|
1 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · No symptoms
|
2 Participants
|
1 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Slight
|
8 Participants
|
14 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Moderate
|
8 Participants
|
5 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Severe
|
0 Participants
|
0 Participants
|
|
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Day 21 · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: 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.
Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 7 · Worse
|
4 Participants
|
4 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 7 · Unchanged
|
8 Participants
|
6 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 7 · Improved
|
8 Participants
|
11 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 14 · Worse
|
5 Participants
|
3 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 14 · Unchanged
|
4 Participants
|
9 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 14 · Improved
|
11 Participants
|
9 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 21 · Worse
|
10 Participants
|
5 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 21 · Unchanged
|
6 Participants
|
10 Participants
|
|
Investigator's Global Assessment of Eczema Change Full Analysis Set
Day 21 · Improved
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Missing
|
1 Participants
|
0 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Worse
|
4 Participants
|
3 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Unchanged
|
7 Participants
|
6 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Improved
|
8 Participants
|
11 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Missing
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 · Worse
|
5 Participants
|
2 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 · Unchanged
|
3 Participants
|
9 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 · Improved
|
10 Participants
|
9 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 · Missing
|
1 Participants
|
0 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Worse
|
10 Participants
|
5 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Unchanged
|
6 Participants
|
9 Participants
|
|
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Improved
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: 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.
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.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
Day 7
|
-11.19 mm
Standard Deviation 26.19
|
-15.19 mm
Standard Deviation 27.23
|
|
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
Day 14
|
-15.34 mm
Standard Deviation 21.28
|
-10.60 mm
Standard Deviation 25.97
|
|
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
Day 21
|
-4.34 mm
Standard Deviation 28.66
|
-13.41 mm
Standard Deviation 27.72
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
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.
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
Day 7
|
-11.32 mm
Standard Deviation 26.90
|
-20.48 mm
Standard Deviation 18.72
|
|
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
Day 14
|
-16.91 mm
Standard Deviation 24.25
|
-14.92 mm
Standard Deviation 18.37
|
|
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
Day 21
|
-2.24 mm
Standard Deviation 29.44
|
-12.89 mm
Standard Deviation 28.34
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: 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.
Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=20 Participants
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
n=21 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 7 · Worse
|
1 Participants
|
2 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 7 · Unchanged
|
14 Participants
|
14 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 7 · Improved
|
5 Participants
|
5 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 14 morning · Worse
|
0 Participants
|
2 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 14 morning · Unchanged
|
13 Participants
|
13 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 14 morning · Improved
|
7 Participants
|
6 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 21 · Worse
|
7 Participants
|
5 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 21 · Unchanged
|
9 Participants
|
8 Participants
|
|
Patient's Global Assessment of Eczema Change Full Analysis Set
Day 21 · Improved
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 7, Day 14 and Day 21Population: The per protocol analysis set is defined as the patients who completed the study according to the protocol.
Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)
Outcome measures
| Measure |
Placebo for DPK-060 Ointment
n=19 Participants
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
n=20 Participants
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2.
|
|---|---|---|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Worse
|
1 Participants
|
0 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Unchanged
|
14 Participants
|
13 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Improved
|
4 Participants
|
5 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 7 · Missing
|
0 Participants
|
2 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 morning · Worse
|
0 Participants
|
1 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 morning · Unchanged
|
9 Participants
|
12 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 morning · Improved
|
5 Participants
|
5 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 14 morning · Missing
|
5 Participants
|
2 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Worse
|
7 Participants
|
5 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Unchanged
|
8 Participants
|
8 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Improved
|
2 Participants
|
7 Participants
|
|
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Day 21 · Missing
|
2 Participants
|
0 Participants
|
Adverse Events
Placebo for DPK-060 Ointment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
DPK-060 1% Ointment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo for DPK-060 Ointment
n=20 participants at risk
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
n=21 participants at risk
DPK-060 1% ointment: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
|
14.3%
3/21
|
|
Nervous system disorders
Headache
|
5.0%
1/20
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
15.0%
3/20
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
4/20
|
19.0%
4/21
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/20
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20
|
4.8%
1/21
|
Additional Information
Margit Mahlapuu PhD, Assoc. Prof. in Molecular Medicine
Pergamum AB
Phone: +46 70 631 01 09
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place