LEO19123 Cream in the Treatment of Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00392067
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : April 30, 2008
Information provided by:
LEO Pharma

October 24, 2006
October 25, 2006
April 30, 2008
October 2006
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Proof of concept
Same as current
Complete list of historical versions of study NCT00392067 on Archive Site
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
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Atopic Dermatitis
Drug: Calcipotriol and LEO80122 (LEO19123 cream)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2007
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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)
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Finland,   United Kingdom
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LEO Pharma
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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