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

Hand Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664805
• Other study ID #: LP0133-1180
• Secondary ID: 2015-002079-11
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2016
• Last updated: March 20, 2018
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eczema
• Hand Eczema

Intervention

Drug:
• LEO 124249 ointment
Ointment
• LEO 124249 ointment vehicle
Ointment vehicle

Locations

Country	Name	City	State
Germany	Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hand Eczema Severity Index (HECSI) at visit 6		56 days
Secondary	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

External Links

•   Clinical Trials at LEO Pharma