Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema

Study Overview
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Brief Summary
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To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.

Official Title
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A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema

Conditions
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Hand Eczema

Intervention / Treatment
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* Drug: LEO 124249 ointment
* Drug: LEO 124249 ointment vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid Physician's Global Assessment of disease severity graded as at least mild at Visit 1 In overall good health including well controlled diseases Exclusion Criteria: Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used). PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization Concurrent skin diseases on the hands Current diagnosis of exfoliative dermatitis Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment A marked abnormal ECG at baseline Known hepatic dysfunction or hepatic dysfunction tested at Screening Current participation in any other interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LEO 124249 ointment<br>Twice daily cutaneous application for 8 weeks | Drug: LEO 124249 ointment<br>* Ointment<br>|
| Placebo Comparator: LEO 124249 ointment vehicle<br>Twice daily cutaneous application for 8 weeks | Drug: LEO 124249 ointment vehicle<br>* Ointment vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment) | Treatment success according to the PGA is defined as: Subjects having mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or almost clear | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Eczema Severity Index (HECSI) at visit 6 |  | 56 days | 
| Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment) | Treatment success according to the PaGA is defined as: Subjects having very mild or mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or very mild | 56 days |