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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

NCT01005823

Atopic Dermatitis

COMPLETED PHASE1

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.

NCT04922021

Atopic Dermatitis

COMPLETED PHASE2

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

NCT05923099

Atopic Dermatitis

COMPLETED PHASE2

Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.

NCT01447758

Atopic Dermatitis

TERMINATED PHASE1

LEO19123 Cream in the Treatment of Hand Eczema

NCT00404196

Hand Eczema

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hand Eczema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LEO 124249 ointment

Twice daily cutaneous application for 8 weeks

Group Type ACTIVE_COMPARATOR

LEO 124249 ointment

Intervention Type DRUG

Ointment

LEO 124249 ointment vehicle

Twice daily cutaneous application for 8 weeks

Group Type PLACEBO_COMPARATOR

LEO 124249 ointment vehicle

Intervention Type DRUG

Ointment vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LEO 124249 ointment

Ointment

Intervention Type DRUG

LEO 124249 ointment vehicle

Ointment vehicle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No