LEO19123 Cream in the Treatment of Hand Eczema

Hand Eczema Clinical Trial

Official title:

LEO19123 Cream in the Treatment of Hand Eczema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404196
• Other study ID #: LEO19123-C22
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2006
• Last updated: August 2, 2007
• Start date: October 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2007
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Hand Eczema

Intervention

Drug:
• Calcipotriol and LEO80122 (LEO19123 cream)

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proof of concept
Secondary	Safety