EO19123 Cream in the Treatment of Hand Eczema A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of hand eczema - LEO19123 Cream in the Treatment of Hand Eczema

Phase 1

• Conditions: Hand eczema; MedDRA version: 8.1 Level: PT Classification code 10058898 Term: Hand dermatitis

• Registration Number: EUCTR2006-002686-39-GB
• Lead Sponsor: EO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-22
• Study Completion: 2007-07-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

1. Clinical diagnosis of hand eczema with or without atopic etiology/background
2. Investigator’s Global Assessment of disease severity graded as at least mild at
Visit 1
3. Patients should be Caucasian males aged from 18 years
4. Attending a hospital outpatient clinic or the private practise of a dermatologist.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Systemic treatment with immunosuppressive drugs (e.g. methotrexate,
cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to
randomisation. (Inhaled or intra-nasal steroids for asthma or rhinitis may be used)
2. PUVA or UVB therapy on the hands within 4 weeks prior to randomisation
3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticoster
-oids from WHO groups III or IV on the hands within 2 weeks prior to
randomisation
4. Other topical therapy on the hands (except for the use of emollients) within 1
week prior to randomisation
5. Use of other treatment (drug, non-drug) on the hands during the study except for
the use of investigational product and emollient
6. Concurrent skin diseases on the hands
7. Current diagnosis of exfoliative dermatitis
8. Significant clinical infection (impetiginised hand eczema) on the hands which
requires antibiotic treatment
9. Known or suspected hypersensitivity to component(s) of the investigational
product
10. Positive patch test as defined in section 11.7.4.2 of the protocol.
11. Known or suspected severe renal insufficiency or severe hepatic disorders
12. Patients with history/signs/symptoms suggestive of an abnormality of calcium
homeo-stasis associated with clinically significant hypercalcaemia
13. Patients with history of cancer except for basal cell carcinoma
14. Current participation in any other interventional clinical trial
15. Patients who have received treatment with any non-marketed drug substance
(i.e. an agent which has not yet been made available for clinical use following
registration) within 4 weeks prior to randomisation
16. Previously randomised in this study
17. 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with hand eczema after once daily treatment for three weeks.;Secondary Objective: To compare the safety LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with hand eczema after once daily treatment for three weeks.;Primary end point(s): Investigator’s global assessment at end of treatment.