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

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ClinicalTrials.gov Identifier: NCT02664805
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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
Hand Eczema Drug: LEO 124249 ointment Drug: LEO 124249 ointment vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : February 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment) [ Time Frame: 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 [ Time Frame: 56 days ]
  2. 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 ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664805


Locations
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Germany
Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany, 10117
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Margitta Worm, Prof Dr Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie

Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02664805     History of Changes
Other Study ID Numbers: LP0133-1180
2015-002079-11 ( EudraCT Number )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous