LEO19123 Cream in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00392067
First received: October 24, 2006
Last updated: April 29, 2008
Last verified: August 2007
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Drug: Calcipotriol and LEO80122 (LEO19123 cream)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: LEO19123 Cream in the Treatment of Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Proof of concept

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 75
Study Start Date: October 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392067

Locations
Canada, Quebec
Clinique Dermatologique Maizerets
Quebec City, Quebec, Canada, G1J 1X7
Denmark
Hudklinikken
Nykøbing F, Denmark, 4800
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00250
United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Kristian Thestrup-Pedersen, MD Hudklinikken
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00392067     History of Changes
Other Study ID Numbers: LEO19123-C21
Study First Received: October 24, 2006
Last Updated: April 29, 2008
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory 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
Calcipotriene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014