Atopic DermatitisPhase 1/2NCT01522391
A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
A Phase 1/2 study testing DPK-060 1% ointment in people with Atopic Dermatitis, run by DermaGen AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DPK-060 1% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2008to Apr 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of atopic dermatitis
- Treatable eczematous lesions of a total area of at least 25 cm2 (100 cm2 for the initial five patients)
- Female patients of childbearing potential had to be using an appropriate method of contraception.
- Female patients of childbearing potential were not eligible before PK data from the first 10 patients had been evaluated and the Medical Products Agency (Swedish regulatory agency) had given approval to include women of childbearing potential.
Who cannot join
- Significant clinical illness, within the two weeks prior to first dose, which could affect the outcome of the study
- Previous local or systemic antimicrobial therapy within the last four weeks prior to the first application of the investigational product (DPK-060 1% or placebo ointment)
- Existence of any surgical or medical condition which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
- Patients who had had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies)on the site of eczema within 14 days prior to first application of DPK-060 1% or placebo ointment and/or topical treatment with tar, any corticosteroid,topical immunomodulators or oral treatment with any corticosteroids within 14 days prior to first application and/or oral antihistamines within 14 days of the first dose.
- A need for any other medication during the period 0 to 7 days before entry to the study, (excluding the oral contraceptive pill for females) except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study
- Diagnosis of other skin diseases, which in the opinion of the investigator, were likely to adversely affect the outcome of the study
Show all 17Show fewer
- History or evidence of significant cardiac, renal, hepatic or endocrine disease
- Significant hypersensitivity or allergy, as judged by the investigator
- Immunocompromised patients
- Lice or scabies
- Tinea corporis
- Hypersensitivity to the ingredients of the vehicle
- The presence of prominent tattoos at sites of application of DPK-060 1% or placebo ointment
- Donation of blood, exceeding 450 mL, during the three months prior to first dose
- Participation in a clinical study during the 12 weeks prior to first dose
- Ongoing alcohol or drug abuse
- Positive pregnancy test or lactation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atopic Dermatitis
- Being tested
- DPK-060 1% ointment, Placebo for DPK-060 ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPK-060 1% ointmentDrug
DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
Placebo for DPK-060 ointmentDrug
Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
| Study group | Role | What they receive |
|---|---|---|
| Placebo for DPK-060 ointment | Placebo comparator | Not described Receives: Drug: Placebo for DPK-060 ointment |
| DPK-060 1% ointment | Experimental | Not described Receives: Drug: DPK-060 1% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 14
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Measured: Baseline and Day 14
Secondary outcomes (26)
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.
Measured: Baseline, Day 7 and 21
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Measured: Baseline, Day 7 and 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
Change in Total Treated Eczema Area Full Analysis Set
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Measured: Baseline, Day 7, Day 14 and Day 21
Change in Total Treated Eczema Area Per Protocol Analysis Set
Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 21
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
Measured: Day 7, Day 14 and Day 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)
Measured: Day 7, Day 14 and Day 21
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)
Measured: Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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.
Measured: Baseline, Day 7, Day 14 and Day 21
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)
Measured: Day 7, Day 14 and Day 21
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)
Measured: Day 7, Day 14 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermaGen AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522391
- Sponsor's protocol ID
- DCS-001
- Other IDs
- 2007-007103-32
- Status last verified
- Dec 2018
- First submitted
- 20 Jan 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
- ClinicalTrials.gov ID
- NCT01522391
- Acronym / sponsor ID
- DCS-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- DermaGen ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo for DPK-060 ointment | Placebo comparator | Drug: Placebo for DPK-060 ointment |
| DPK-060 1% ointment | Experimental | Drug: DPK-060 1% ointment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical diagnosis of atopic dermatitis
- Treatable eczematous lesions of a total area of at least 25 cm2 (100 cm2 for the initial five patients)
- Female patients of childbearing potential had to be using an appropriate method of contraception.
- Female patients of childbearing potential were not eligible before PK data from the first 10 patients had been evaluated and the Medical Products Agency (Swedish regulatory agency) had given approval to include women of childbearing potential.
Key exclusion criteria (17 listed)
- Significant clinical illness, within the two weeks prior to first dose, which could affect the outcome of the study
- Previous local or systemic antimicrobial therapy within the last four weeks prior to the first application of the investigational product (DPK-060 1% or placebo ointment)
- Existence of any surgical or medical condition which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
- Patients who had had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies)on the site of eczema within 14 days prior to first application of DPK-060 1% or placebo ointment and/or topical treatment with tar, any corticosteroid,topical immunomodulators or oral treatment with any corticosteroids within 14 days prior to first application and/or oral antihistamines within 14 days of the first dose.
- A need for any other medication during the period 0 to 7 days before entry to the study, (excluding the oral contraceptive pill for females) except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPK-060 1% ointmentDPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 | Drug | DPK-060 1% ointment |
| Placebo for DPK-060 ointmentPlacebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 | Drug | Placebo for DPK-060 ointment |
Primary outcome
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set
Time frame: Baseline and Day 14
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set
Time frame: Baseline and Day 14
The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.
26 secondary outcomes
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set
Time frame: Baseline, Day 7 and 21
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set
Time frame: Baseline, Day 7 and 21
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Change in Total Treated Eczema Area Full Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Change in Total Treated Eczema Area Per Protocol Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Change in Area of Microbial Counting Site Full Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Change in Area of Microbial Counting Site Per Protocol Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Erythema Eczema Area and Severity Index (EASI) Full Analysis Set
Time frame: Day 7, Day 14 and Day 21
Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Time frame: Day 7, Day 14 and Day 21
Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set
Time frame: Day 7, Day 14 and Day 21
Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Time frame: Day 7, Day 14 and Day 21
Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set
Time frame: Day 7, Day 14 and Day 21
Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Time frame: Day 7, Day 14 and Day 21
Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set
Time frame: Day 7, Day 14 and Day 21
Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set
Time frame: Day 7, Day 14 and Day 21
Investigator's Global Assessment of Eczema Change Full Analysis Set
Time frame: Day 7, Day 14 and Day 21
Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set
Time frame: Day 7, Day 14 and Day 21
Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set
Time frame: Baseline, Day 7, Day 14 and Day 21
Patient's Global Assessment of Eczema Change Full Analysis Set
Time frame: Day 7, Day 14 and Day 21
Patient's Global Assessment of Eczema Change Per Protocol Analysis Set
Time frame: Day 7, Day 14 and Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DPK-060 1% ointment in people with Atopic Dermatitis, run by DermaGen AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set (time frame: Baseline and Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.