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Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)

This study has been completed.
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01228513
First received: October 14, 2010
Last updated: July 19, 2012
Last verified: December 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to placebo in the treatment of atopic dermatitis.


Condition Intervention Phase
Atopic Dermatitis
 Drug: ZK245186
Drug: Placebo (vehicle without active ingredient)
 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: Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis (AD)

Resource links provided by NLM:

MedlinePlus related topics: Itching
U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:
  • Eczema Area and Severity Index (EASI) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured after one week of treatment ] [ Designated as safety issue: No ]
    Ezcema area and severity index

  • EASI [ Time Frame: Measured at the end of 2 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured at the end of 3 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured at the end of 4 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index


Secondary Outcome Measures:
  • Subjects' assessment of pruritus [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after one week of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after two weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after three weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after four weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale


Enrollment: 263
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.01% ointment
Lowest concentration
 Drug: ZK245186
Daily topical application
Active Comparator: 0.03% ointment
Middle concentration
 Drug: ZK245186
Daily topical application
Active Comparator: 0.1% ointment
Highest concentration
 Drug: ZK245186
Daily topical application
Placebo Comparator: Placebo (vehicle without active)
No active ingredient
 Drug: Placebo (vehicle without active ingredient)
Daily topical application

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
  • Body surface area affected by atopic dermatitis at or less than 15% at start of treatment

Exclusion Criteria:

  • Pregnancy and breast-feeding
  • Conditions that may pose a threat to the patient or effect the outcome of the study
  • Wide-spread atopic dermatitis (AD) requiring systemic treatment
  • Immuno-compromized conditions
  • At least 2 weeks after local AD treatment and treatment with systemic antibiotics
  • At least 1 month after systemic AD treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228513

Locations
United States, Massachusetts
Alexandra Boer Kimball, MD
Boston, Massachusetts, United States, 0214-2517
Sponsors and Collaborators
Intendis GmbH
Investigators
Study Director: Kathrin Vick, MD Intendis GmbH, Berlin, Germany
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alexandra Boer Kimball, MD, Mass General Women's Hospital, Havard Medical School
ClinicalTrials.gov Identifier: NCT01228513     History of Changes
Other Study ID Numbers: 1403380
Study First Received: October 14, 2010
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013