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

October 24, 2006
April 29, 2008
October 2006
Not Provided
Proof of concept
Same as current
Complete list of historical versions of study NCT00392067 on ClinicalTrials.gov Archive Site
Safety
Same as current
Not Provided
Not Provided
 
LEO19123 Cream in the Treatment of Atopic Dermatitis
LEO19123 Cream in the Treatment of Atopic Dermatitis

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atopic Dermatitis
Drug: Calcipotriol and LEO80122 (LEO19123 cream)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2007
Not Provided

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)
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Finland,   United Kingdom
 
NCT00392067
LEO19123-C21
Not Provided
Not Provided
LEO Pharma
Not Provided
Principal Investigator: Kristian Thestrup-Pedersen, MD Hudklinikken
LEO Pharma
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP