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LEO19123 Cream in the Treatment of Hand Eczema
This study has been completed.
First Received: November 27, 2006   Last Updated: August 2, 2007   History of Changes
Sponsored by: LEO Pharma
Information provided by: LEO Pharma
ClinicalTrials.gov Identifier: NCT00404196
  Purpose

To compare the efficacy and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.


Condition Intervention Phase
Hand Eczema
Drug: Calcipotriol and LEO80122 (LEO19123 cream)
Phase II

MedlinePlus related topics: Eczema
Drug Information available for: Calcipotriene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: LEO19123 Cream in the Treatment of Hand Eczema

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: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of hand eczema with or without atopic etiology/background
  • Investigator.s Global Assessment of disease severity graded as at least mild at Visit 1
  • Patients should be Caucasian males aged from 18 years
  • Attending a hospital outpatient clinic or the private practise of a dermatologist.
  • Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods.

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 on the hands within 4 weeks prior to randomisation.
  • Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV on the hands within 2 weeks prior to randomisation.
  • Other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation.
  • Use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient.
  • Concurrent skin diseases on the hands.
  • Current diagnosis of exfoliative dermatitis.
  • Significant clinical infection (impetiginised hand eczema) on the hands, which requires antibiotic treatment.
  • Known or suspected hypersensitivity to component(s) of the investigational product.
  • Positive patch test as defined in protocol
  • 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 except for basal cell carcinoma.
  • Current participation in any other interventional clinical trial.
  • Patients who have received treatment with any nonmarketed 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, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404196

Locations
United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: John SC English, MB Queen's Medical Centre
  More Information

No publications provided

Study ID Numbers: LEO19123-C22
Study First Received: November 27, 2006
Last Updated: August 2, 2007
ClinicalTrials.gov Identifier: NCT00404196     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Calcipotriene
Skin Diseases
Skin Diseases, Eczematous
Eczema
Dermatitis

Additional relevant MeSH terms:
Calcipotriene
Skin Diseases
Therapeutic Uses
Skin Diseases, Eczematous
Eczema
Dermatologic Agents
Pharmacologic Actions
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009