Overview

This trial has been completed.

Condition hand eczema
Treatments leo 124249 ointment, leo 124249 ointment vehicle
Phase phase 2
Sponsor LEO Pharma
Start date February 2016
End date July 2016
Trial size 91 participants
Trial identifier NCT02664805, 2015-002079-11, LP0133-1180

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Twice daily cutaneous application for 8 weeks
leo 124249 ointment
Ointment
(Placebo Comparator)
Twice daily cutaneous application for 8 weeks
leo 124249 ointment vehicle
Ointment vehicle

Primary Outcomes

Measure
Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment)
time frame: 56 days

Secondary Outcomes

Measure
Hand Eczema Severity Index (HECSI) at visit 6
time frame: 56 days
Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment)
time frame: 56 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
Principal investigator Margitta Worm, Prof Dr
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by LEO Pharma.