LEO19123 Cream in the Treatment of Atopic Dermatitis

April 29, 2008 updated by: LEO Pharma
To compare the efficacy and safety of two different dose combinations of LEO19123 (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with atopic dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1J 1X7
        • Clinique Dermatologique Maizerets
  • Denmark
      • Nykøbing F, Denmark, 4800
        • Hudklinikken
  • Finland
      • Helsinki, Finland, 00250
        • Helsinki University Central Hospital
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka
  • The score of erythema, induration/papulation, excoriation and lichenification, four of the five clinical signs in the Total Severity Score, should at least correspond to moderate involvement, i.e. severity greater than or equal to 2, at Visit 1
  • Treatment area amenable to topical treatment
  • Attending a hospital outpatient clinic or the private practice of a dermatologist
  • Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period
  • Males between 18-50 years

Exclusion Criteria:

  • Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
  • PUVA or UVB therapy within 4 weeks prior to randomisation
  • Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV within 2 weeks prior to randomisation
  • Other topical therapy on the treatment area (except for the use of emollient on the entire body and use of hydrocortisone cream 1% on AD lesions on head and neck) within 1 week prior to randomisation
  • Use of any other kind of treatment (drug, non-drug) for AD during the study except for the use of: - Investigational product on trunk and limbs lesions only during the treatment phase - Hydrocortisone cream 1% on head and neck lesions - Emollient on the entire body
  • Use of anti-histamines during the study
  • Current diagnosis of exfoliative erythrodermia
  • Clinical infection (impetiginised atopic dermatitis) on the treatment area
  • Planned exposure to amount of sun or ultraviolet light during the study that may affect atopic dermatitis
  • Known or suspected hypersensitivity to component(s) of the investigational product
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
  • Patients with history of cancer including skin cancer
  • Patients with history of an immunocompromised disease (e.g. lymphoma, HIV, Wiskott-Aldrich Syndrome)
  • Current participation in any other interventional clinical trial
  • Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation
  • Previously randomised in this study
  • Patients known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proof of concept

Secondary Outcome Measures

Outcome Measure
Safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Kristian Thestrup-Pedersen, MD, Hudklinikken

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (ESTIMATE)

October 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 29, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEO19123-C21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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