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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Hand Eczema

Treatments: Drug: LEO 124249 ointment; Drug: LEO 124249 ointment vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02664805

LP0133-1180

2015-002079-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups, including a placebo group

LEO 124249 ointment

Active Comparator group

Description:

Twice daily cutaneous application for 8 weeks

Treatment:

Drug: LEO 124249 ointment

LEO 124249 ointment vehicle

Placebo Comparator group

Description:

Twice daily cutaneous application for 8 weeks

Treatment:

Drug: LEO 124249 ointment vehicle