LEO19123 Cream in the Treatment of Hand Eczema
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.
Status: Completed (Phase 2). Started on October 1st, 2006. Ended on March 1st, 2007.
Enrollment: 75 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Double-Blind
- Placebo Control
- Parallel Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Drug: Calcipotriol and LEO80122 (LEO19123 cream)
Eligibility
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).
- Gender
Male
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: LEO Pharma
Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Locations
-
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Officials
John SC English, MB (Principal Investigator, Queen's Medical Centre)
Sponsors
LEO Pharma (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- August 1st, 2007
- First Received
- August 2nd, 2007
- Last Changed
- August 2nd, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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