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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DermaGen AB
ClinicalTrials.gov Identifier:
NCT01522391
First received: January 20, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Atopic Dermatitis
Drug: DPK-060 1% ointment
Drug: Placebo for DPK-060 ointment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by DermaGen AB:

Primary Outcome Measures:
  • Microbial density (microbial CFU/cm2) in eczematous lesions [ Time Frame: Change from baseline to end-of-treatment (i.e. on Day 14) ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522391

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

No publications provided

Responsible Party: DermaGen AB
ClinicalTrials.gov Identifier: NCT01522391     History of Changes
Other Study ID Numbers: DCS-001, 2007-007103-32
Study First Received: January 20, 2012
Last Updated: January 27, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014