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

Sponsor
LEO Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02664805
Collaborator
(none)
91
Enrollment
1
Location
2
Arms
8
Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: LEO 124249 ointment
  • Drug: LEO 124249 ointment vehicle
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment) [56 days]

    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

Secondary Outcome Measures

  1. Hand Eczema Severity Index (HECSI) at visit 6 [56 days]

  2. Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment) [56 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie Berlin Germany 10117

Sponsors and Collaborators

  • LEO Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT02664805
Other Study ID Numbers:
  • LP0133-1180
  • 2015-002079-11
First Posted:
Jan 27, 2016
Last Update Posted:
Mar 21, 2018
Last Verified:
Mar 1, 2018
Additional relevant MeSH terms:
Eczema

Study Results

No Results Posted as of Mar 21, 2018