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CompletedNCT01522391Updated Dec 5, 2018Results posted

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

A Phase 1/2 interventional study of DPK-060 1% ointment and Placebo for DPK-060 ointment in Atopic Dermatitis, sponsored by DermaGen AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by DermaGen AB · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was preceded with an open-label investigation in a small group of patients (n=5) treated with two applications of DPK-060 1% ointment per day for four days to assess safety, local tolerability and systemic absorption of DPK-060.

The secondary objectives were to evaluate severity of eczema and pruritus, to assess the tolerability and safety of the treatment and to assess the degree of systemic absorption of DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 41 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

DermaGen AB is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A clinical diagnosis of atopic dermatitis
  • Treatable eczematous lesions of a total area of at least 25 cm2 (100 cm2 for the initial five patients)
  • Female patients of had to be using an appropriate method of .
  • Female patients of childbearing potential were not eligible before PK data from the first 10 patients had been evaluated and the Medical Products Agency (Swedish regulatory agency) had given approval to include women of childbearing potential.

Exclusion criteria

Exclusion Criteria:

  • Significant clinical illness, within the two weeks prior to first dose, which could affect the outcome of the study
  • Previous local or systemic antimicrobial therapy within the last four weeks prior to the first application of the product (DPK-060 1% or placebo ointment)
  • Existence of any surgical or medical condition which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
  • Patients who had had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies)on the site of eczema within 14 days prior to first application of DPK-060 1% or placebo ointment and/or topical treatment with tar, any ,topical immunomodulators or oral treatment with any corticosteroids within 14 days prior to first application and/or oral antihistamines within 14 days of the first dose.
  • A need for any other medication during the period 0 to 7 days before entry to the study, (excluding the oral pill for females) except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study
  • Diagnosis of other skin diseases, which in the opinion of the investigator, were likely to adversely affect the outcome of the study
  • History or evidence of significant cardiac, renal, hepatic or endocrine disease
  • Significant or allergy, as judged by the investigator
  • patients
  • Lice or scabies
  • Tinea corporis
  • Hypersensitivity to the ingredients of the vehicle
  • The presence of prominent tattoos at sites of application of DPK-060 1% or placebo ointment
  • Donation of blood, exceeding 450 mL, during the three months prior to first dose
  • Participation in a clinical study during the 12 weeks prior to first dose
  • Ongoing alcohol or drug abuse
  • Positive pregnancy test or lactation
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Placebo comparator
    Placebo for DPK-060 ointment

    Drug: Placebo for DPK-060 ointment

  • Experimental
    DPK-060 1% ointment

    Drug: DPK-060 1% ointment

Interventions

  • DrugDPK-060 1% ointment

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

  • DrugPlacebo for DPK-060 ointment

    Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set

    The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

    Time frame: Baseline and Day 14

  2. Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set

    The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

    Time frame: Baseline and Day 14

Secondary outcomes

  1. Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set

    The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

    Time frame: Baseline, Day 7 and 21

  2. Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set

    The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

    Time frame: Baseline, Day 7 and 21

  3. Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set

    The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  4. Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

    The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  5. Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set

    The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  6. Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

    The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  7. Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set

    The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  8. Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

    The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  9. Change in Total Treated Eczema Area Full Analysis Set

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

    Time frame: Baseline, Day 7, Day 14 and Day 21

  10. Change in Total Treated Eczema Area Per Protocol Analysis Set

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

    Time frame: Baseline, Day 7, Day 14 and Day 21

  11. Change in Area of Microbial Counting Site Full Analysis Set

    Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  12. Change in Area of Microbial Counting Site Per Protocol Analysis Set

    Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  13. Erythema Eczema Area and Severity Index (EASI) Full Analysis Set

    Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  14. Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

    Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  15. Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set

    Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  16. Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

    Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  17. Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set

    Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  18. Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

    Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  19. Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set

    Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  20. Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

    Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

    Time frame: Day 7, Day 14 and Day 21

  21. Investigator's Global Assessment of Eczema Change Full Analysis Set

    Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

    Time frame: Day 7, Day 14 and Day 21

  22. Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set

    Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

    Time frame: Day 7, Day 14 and Day 21

  23. Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set

    The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.

    Time frame: Baseline, Day 7, Day 14 and Day 21

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

    The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.

    Time frame: Baseline, Day 7, Day 14 and Day 21

  25. Patient's Global Assessment of Eczema Change Full Analysis Set

    Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

    Time frame: Day 7, Day 14 and Day 21

  26. Patient's Global Assessment of Eczema Change Per Protocol Analysis Set

    Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

    Time frame: Day 7, Day 14 and Day 21

07

Results

Posted Dec 5, 2018

Participant flow

Participant flow — Overall Study
MilestonePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Started2021
Completed1920
Not completed11

Outcome measures

PrimaryPercent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set

The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

Time frame:
Baseline and Day 14
Reported as:
Median · Percent change
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set-94 (-100 to 19483)-100 (-100 to 40926)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.012 · Ratio between geometric means: 0.045 · 95% CI 0.004 to 0.491
PrimaryPercent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set

The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

Time frame:
Baseline and Day 14
Reported as:
Median · Percent change
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set-90 (-100 to 19483)-100 (-100 to -52)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.012 · Ratio between geometric means: 0.045 · 95% CI 0.004 to 0.491
SecondaryPercent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set

The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

Time frame:
Baseline, Day 7 and 21
Reported as:
Median · Percent change
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7-73 (-100 to 73429)-98 (-100 to 40926)
Day 2114 (-99 to 294067)-37 (-100 to 40926)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.242 · Ratio between geometric means: 0.242 · 95% CI 0.022 to 2.66
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.482 · Ratio between geometric means: 0.428 · 95% CI 0.039 to 4.696
SecondaryPercent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set

The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

Time frame:
Baseline, Day 7 and 21
Reported as:
Median · Percent change
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7-73 (-100 to 73429)-96 (-100 to 563)
Day 2120 (-99 to 294067)-49 (-100 to 14344)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.242 · Ratio between geometric means: 0.242 · 95% CI 0.022 to 2.660
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.482 · Ratio between geometric means: 0.428 · 95% CI 0.039 to 4.696
SecondaryPercent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set

The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Median · Percent change
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7-50 (-100 to 73429)-100 (-100 to 799900)
Day 14-91 (-100 to 1665)-100 (-100 to 799900)
Day 2124 (-100 to 21900)-2 (-100 to 799900)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.395 · Ratio between geometric means: 0.288 · 95% CI 0.016 to 5.221
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.067 · Ratio between geometric means: 0.067 · 95% CI 0.004 to 1.218
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.620 · Ratio between geometric means: 0.484 · 95% CI 0.027 to 8.787
SecondaryPercent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Median · Percent change
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7-60 (-100 to 73429)-100 (-100 to 546)
Day 14-91 (-100 to 1665)-100 (-100 to -77)
Day 2124 (-100 to 21900)-36 (-100 to 3614)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.403 · Ratio between geometric means: 0.287 · 95% CI 0.015 to 5.550
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.021 · Ratio between geometric means: 0.032 · 95% CI 0.002 to 0.583
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.368 · Ratio between geometric means: 0.271 · 95% CI 0.015 to 4.779
SecondaryPercent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set

The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Median · Percent change
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
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)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.970 · Ratio between geometric means: 1.045 · 95% CI 0.106 to 10.32
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.009 · Ratio between geometric means: 0.045 · 95% CI 0.005 to 0.447
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.377 · Ratio between geometric means: 0.360 · 95% CI 0.036 to 3.556
SecondaryPercent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Median · Percent change
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
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)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.974 · Ratio between geometric means: 0.961 · 95% CI 0.081 to 11.43
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.013 · Ratio between geometric means: 0.046 · 95% CI 0.004 to 0.512
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.504 · Ratio between geometric means: 0.447 · 95% CI 0.041 to 4.883
SecondaryPercent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set

The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Median · Percent change
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7-73 (-100 to 73429)-98 (-100 to 40926)
Day 14-94 (-100 to 19483)-100 (-100 to 40926)
Day 2114 (-99 to 291567)-37 (-100 to 40926)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.242 · Ratio between geometric means: 0.242 · 95% CI 0.022 to 2.659
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.012 · Ratio between geometric means: 0.045 · 95% CI 0.004 to 0.491
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.483 · Ratio between geometric means: 0.428 · 95% CI 0.039 to 4.697
SecondaryPercent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set

The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Median · Percent change
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Percent changePlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7-73 (-100 to 73429)-96 (-100 to 563)
Day 14-90 (-100 to 19483)-100 (-100 to -52)
Day 2120 (-99 to 291567)-49 (-100 to 14344)
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.197 · Ratio between geometric means: 0.202 · 95% CI 0.017 to 2.340
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.002 · Ratio between geometric means: 0.021 · 95% CI 0.002 to 0.227
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.257 · Ratio between geometric means: 0.257 · 95% CI 0.024 to 2.752
SecondaryChange in Total Treated Eczema Area Full Analysis Set

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

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Mean · cm2
Change in Total Treated Eczema Area Full Analysis Set
cm2Placebo for DPK-060 OintmentDPK-060 1% Ointment
Day 712.0 ± 32.832.3 ± 92.2
Day 14-15.0 ± 42.914.1 ± 82.7
Day 2117.4 ± 78.75.8 ± 60.8
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.346 · Least square mean difference: 20.38 · 95% CI -22.42 to 63.19
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.18 · Least square mean difference: 29.10 · 95% CI -13.71 to 71.90
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.590 · Least square mean difference: -11.64 · 95% CI -54.44 to 31.16
SecondaryChange in Total Treated Eczema Area Per Protocol Analysis Set

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

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Mean · cm2
Change in Total Treated Eczema Area Per Protocol Analysis Set
cm2Placebo for DPK-060 OintmentDPK-060 1% Ointment
Day 712.1 ± 33.718.0 ± 66.4
Day 14-16.0 ± 44.9-1.2 ± 45.4
Day 2121.1 ± 82.42.4 ± 60.3
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.748 · Least square mean difference: 5.95 · 95% CI -30.84 to 42.73
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.437 · Least square mean difference: 14.62 · 95% CI -22.65 to 51.88
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.322 · Least square mean difference: -18.66 · 95% CI -55.92 to 18.61
SecondaryChange in Area of Microbial Counting Site Full Analysis Set

Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Mean · cm2
Change in Area of Microbial Counting Site Full Analysis Set
cm2Placebo for DPK-060 OintmentDPK-060 1% Ointment
Day 712.1 ± 25.520.1 ± 68.0
Day 14-16.3 ± 32.24.2 ± 49.1
Day 218.9 ± 66.07.6 ± 62.3
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.631 · Least square mean difference: 8.04 · 95% CI -25.15 to 41.24
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.224 · Least square mean difference: 20.44 · 95% CI -12.75 to 53.63
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.941 · Least square mean difference: -1.23 · 95% CI -34.42 to 31.96
SecondaryChange in Area of Microbial Counting Site Per Protocol Analysis Set

Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Mean · cm2
Change in Area of Microbial Counting Site Per Protocol Analysis Set
cm2Placebo for DPK-060 OintmentDPK-060 1% Ointment
Day 713.3 ± 26.715.3 ± 66.0
Day 14-18.2 ± 33.4-1.5 ± 42.8
Day 219.8 ± 69.72.2 ± 58.5
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.954 · Least square means difference: 0.97 · 95% CI -32.93 to 34.87
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.358 · Least square mean difference: 15.72 · 95% CI -18.18 to 49.62
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Mixed Models Analysis · p = 0.642 · Least square mean difference: -7.94 · 95% CI -41.82 to 25.94
SecondaryErythema Eczema Area and Severity Index (EASI) Full Analysis Set

Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms00
Day 7 — Slight1113
Day 7 — Moderate87
Day 7 — Severe11
Day 14 — No symptoms00
Day 14 — Slight1111
Day 14 — Moderate89
Day 14 — Severe11
Day 21 — No symptoms00
Day 21 — Slight1014
Day 21 — Moderate86
Day 21 — Severe21
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.701
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.898
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.271
SecondaryErythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms00
Day 7 — Slight1013
Day 7 — Moderate86
Day 7 — Severe11
Day 7 — Missing00
Day 14 — No symptoms00
Day 14 — Slight911
Day 14 — Moderate88
Day 14 — Severe11
Day 14 — Missing10
Day 21 — No symptoms00
Day 21 — Slight813
Day 21 — Moderate86
Day 21 — Severe21
Day 21 — Missing10
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.511
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.777
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.204
SecondaryExcoriations Eczema Area and Severity Index (EASI) Full Analysis Set

Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms56
Day 7 — Slight710
Day 7 — Moderate63
Day 7 — Severe22
Day 14 — No symptoms69
Day 14 — Slight78
Day 14 — Moderate74
Day 14 — Severe00
Day 21 — No symptoms58
Day 21 — Slight69
Day 21 — Moderate84
Day 21 — Severe10
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.489
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.249
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.098
SecondaryExcoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms46
Day 7 — Slight710
Day 7 — Moderate62
Day 7 — Severe22
Day 7 — Missing00
Day 14 — No symptoms59
Day 14 — Slight68
Day 14 — Moderate73
Day 14 — Severe00
Day 14 — Missing10
Day 21 — No symptoms38
Day 21 — Slight68
Day 21 — Moderate84
Day 21 — Severe10
Day 21 — Missing10
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.291
  • DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.113
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.033
SecondaryInfiltration Eczema Area and Severity Index (EASI) Full Analysis Set

Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms44
Day 7 — Slight1312
Day 7 — Moderate25
Day 7 — Severe10
Day 14 — No symptoms55
Day 14 — Slight911
Day 14 — Moderate65
Day 14 — Severe00
Day 21 — No symptoms57
Day 21 — Slight79
Day 21 — Moderate65
Day 21 — Severe20
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.825
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.825
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.208
SecondaryInfiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms44
Day 7 — Slight1211
Day 7 — Moderate25
Day 7 — Severe10
Day 7 — Missing00
Day 14 — No symptoms55
Day 14 — Slight710
Day 14 — Moderate65
Day 14 — Severe00
Day 14 — Missing10
Day 21 — No symptoms37
Day 21 — Slight78
Day 21 — Moderate65
Day 21 — Severe20
Day 21 — Missing10
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.825
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.820
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.086
SecondaryLichenification Eczema Area and Severity Index (EASI) Full Analysis Set

Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms03
Day 7 — Slight1412
Day 7 — Moderate66
Day 7 — Severe00
Day 14 — No symptoms44
Day 14 — Slight910
Day 14 — Moderate77
Day 14 — Severe00
Day 21 — No symptoms41
Day 21 — Slight815
Day 21 — Moderate85
Day 21 — Severe00
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.378
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.975
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.962
SecondaryLichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set

Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — No symptoms03
Day 7 — Slight1311
Day 7 — Moderate66
Day 7 — Severe00
Day 7 — Missing00
Day 14 — No symptoms44
Day 14 — Slight79
Day 14 — Moderate77
Day 14 — Severe00
Day 14 — Missing10
Day 21 — No symptoms21
Day 21 — Slight814
Day 21 — Moderate85
Day 21 — Severe00
Day 21 — Missing10
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.375
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.946
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Cochran-Mantel-Haenszel · p = 0.495
SecondaryInvestigator's Global Assessment of Eczema Change Full Analysis Set

Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Investigator's Global Assessment of Eczema Change Full Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — Worse44
Day 7 — Unchanged86
Day 7 — Improved811
Day 14 — Worse53
Day 14 — Unchanged49
Day 14 — Improved119
Day 21 — Worse105
Day 21 — Unchanged610
Day 21 — Improved46
SecondaryInvestigator's Global Assessment of Eczema Change Per Protocol Analysis Set

Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — Worse43
Day 7 — Unchanged76
Day 7 — Improved811
Day 7 — Missing00
Day 14 — Worse52
Day 14 — Unchanged39
Day 14 — Improved109
Day 14 — Missing10
Day 21 — Worse105
Day 21 — Unchanged69
Day 21 — Improved26
Day 21 — Missing10
SecondaryChange From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set

The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Mean · mm
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
mmPlacebo for DPK-060 OintmentDPK-060 1% Ointment
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
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Wilcoxon (Mann-Whitney) · p = 0.477
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Wilcoxon (Mann-Whitney) · p = 0.651
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Wilcoxon (Mann-Whitney) · p = 0.340
SecondaryChange From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set

The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.

Time frame:
Baseline, Day 7, Day 14 and Day 21
Reported as:
Mean · mm
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
mmPlacebo for DPK-060 OintmentDPK-060 1% Ointment
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
Statistical analysis
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Wilcoxon (Mann-Whitney) · p = 0.300
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Wilcoxon (Mann-Whitney) · p = 0.705
  • Placebo for DPK-060 Ointment vs DPK-060 1% Ointment · Wilcoxon (Mann-Whitney) · p = 0.286
SecondaryPatient's Global Assessment of Eczema Change Full Analysis Set

Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Patient's Global Assessment of Eczema Change Full Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — Worse12
Day 7 — Unchanged1414
Day 7 — Improved55
Day 14 morning — Worse02
Day 14 morning — Unchanged1313
Day 14 morning — Improved76
Day 21 — Worse75
Day 21 — Unchanged98
Day 21 — Improved48
SecondaryPatient's Global Assessment of Eczema Change Per Protocol Analysis Set

Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

Time frame:
Day 7, Day 14 and Day 21
Reported as:
Count of participants · Participants
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
ParticipantsPlacebo for DPK-060 OintmentDPK-060 1% Ointment
Day 7 — Worse10
Day 7 — Unchanged1413
Day 7 — Improved45
Day 7 — Missing02
Day 14 morning — Worse01
Day 14 morning — Unchanged912
Day 14 morning — Improved55
Day 14 morning — Missing52
Day 21 — Worse75
Day 21 — Unchanged88
Day 21 — Improved27
Day 21 — Missing20

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo for DPK-060 Ointment—0/20 (0%)7/20 (35%)
DPK-060 1% Ointment—0/21 (0%)10/21 (47.6%)
Most frequent other events
Most frequent other events
EventPlacebo for DPK-060 OintmentDPK-060 1% Ointment
PruritusSkin and subcutaneous tissue disorders4/204/21
Pain of skinSkin and subcutaneous tissue disorders3/200/21
NasopharyngitisInfections and infestations0/203/21
HeadacheNervous system disorders1/202/21
EczemaSkin and subcutaneous tissue disorders0/202/21
Skin burning sensationSkin and subcutaneous tissue disorders0/202/21
UrticariaSkin and subcutaneous tissue disorders1/201/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo for DPK-060 OintmentDPK-060 1% OintmentTotal
<=18 years000
Between 18 and 65 years202141
>=65 years000
Age, Continuous
Age, Continuous(years)Placebo for DPK-060 OintmentDPK-060 1% OintmentTotal
Mean31.9 ± 14.633.1 ± 13.532.5 ± 13.9
Sex: Female, Male
Sex: Female, Male(Participants)Placebo for DPK-060 OintmentDPK-060 1% OintmentTotal
Female141630
Male6511
Region of Enrollment
Region of Enrollment(participants)Placebo for DPK-060 OintmentDPK-060 1% OintmentTotal
Sweden202141
08

Study locations

1 site
  • Quintiles Hermelinen AB
    Luleå, Sweden
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01522391
Lead sponsor
DermaGen AB
Responsible party
Sponsor
First posted
Jan 31, 2012
Start date
Mar 2008
Primary completion
Apr 2009
Completion
Apr 2009
Results posted
Dec 5, 2018
Last update
Dec 5, 2018
View the source record on ClinicalTrials.gov ↗

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