LEO19123 Cream in the Treatment of Hand Eczema

NCT ID: NCT00404196

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-03-31

Brief Summary

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.

Conditions

Hand Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Calcipotriol and LEO80122 (LEO19123 cream)

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

Queen's Medical Centre

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

LEO19123-C22

Identifier Type: -

Identifier Source: org_study_id