LEO19123 Cream in the Treatment of Hand Eczema

NCT00404196 | Completed Phase 2

• 1 other identifier: LEO19123-C22
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proof of concept

Secondary Outcomes (1)

• Safety

Interventions

Calcipotriol and LEO80122 (LEO19123 cream) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

calcipotriene

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: October 1, 2006
• Study Completion: March 1, 2007
• Last Updated: February 24, 2025

Record last verified: 2007-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)