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

NCT02664805 | Completed Phase 2

• 2 other identifiers: LP0133-11802015-002079-11
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

  56 days

Study Arms (2)

LEO 124249 ointment

ACTIVE COMPARATOR

Twice daily cutaneous application for 8 weeks

Drug: LEO 124249 ointment

LEO 124249 ointment vehicle

PLACEBO COMPARATOR

Twice daily cutaneous application for 8 weeks

Drug: LEO 124249 ointment vehicle

Interventions

LEO 124249 ointment DRUG

Ointment

LEO 124249 ointment

LEO 124249 ointment vehicle DRUG

Ointment vehicle

LEO 124249 ointment vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie

Berlin, 10117, Germany

Location

Related Links

• LEO Pharma Clinical Trials

Study Officials

• Margitta Worm, Prof Dr

  Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 29, 2026

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)