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Trial record 26 of 453 for:    applied AND ointment

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

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ClinicalTrials.gov Identifier: NCT01522391
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
DermaGen AB

Brief Summary:

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

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


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DPK-060 1% ointment Drug: Placebo for DPK-060 ointment Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo for DPK-060 ointment Drug: 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

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

  2. 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 ]
    The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.

  3. 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 ]
    The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.

  4. 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 ]
    The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.

  5. 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 ]
    The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.

  6. 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 ]
    The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.

  7. 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 ]
    The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.

  8. 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 ]
    The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.

  9. Change in Total Treated Eczema Area Full Analysis Set [ Time Frame: Baseline, Day 7, Day 14 and Day 21 ]
    Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.

  10. Change in Total Treated Eczema Area Per Protocol Analysis Set [ Time Frame: Baseline, Day 7, Day 14 and Day 21 ]
    Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.

  11. Change in Area of Microbial Counting Site Full Analysis Set [ Time Frame: Baseline, Day 7, Day 14 and Day 21 ]
    Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.

  12. Change in Area of Microbial Counting Site Per Protocol Analysis Set [ Time Frame: Baseline, Day 7, Day 14 and Day 21 ]
    Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.

  13. Erythema Eczema Area and Severity Index (EASI) Full Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  14. Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  15. Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  16. Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  17. Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  18. Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  19. Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  20. Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe

  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 status since previous dose application on a categorical scale (worse, unchanged, improved)

  22. Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)

  23. Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set [ Time Frame: Baseline, Day 7, Day 14 and Day 21 ]
    The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.

  24. Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set [ Time Frame: Baseline, Day 7, Day 14 and Day 21 ]
    The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.

  25. 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 status since previous dose application on a categorical scale (worse, unchanged, improved)

  26. Patient's Global Assessment of Eczema Change Per Protocol Analysis Set [ Time Frame: Day 7, Day 14 and Day 21 ]
    Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522391


Locations
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Sweden
Quintiles Hermelinen AB
Luleå, Sweden
Sponsors and Collaborators
DermaGen AB

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Responsible Party: DermaGen AB
ClinicalTrials.gov Identifier: NCT01522391     History of Changes
Other Study ID Numbers: DCS-001
2007-007103-32 ( EudraCT Number )
First Posted: January 31, 2012    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Infective Agents
Anti-Bacterial Agents