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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: LEO 124249 ointment; Drug: LEO 124249 ointment vehicle

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LEO 124249 ointment; Twice daily cutaneous application for 8 weeks	Drug: LEO 124249 ointment; Ointment
Placebo Comparator: LEO 124249 ointment vehicle; Twice daily cutaneous application for 8 weeks	Drug: LEO 124249 ointment vehicle; Ointment vehicle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Margitta Worm, Prof Dr, Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie

Publications and helpful links

Helpful Links

• LEO Pharma Clinical Trials

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimated): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Eczema
• Other Study ID Numbers: LP0133-1180; 2015-002079-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO