Chronic Hand EczemaPhase 2NCT02664805
Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
A Phase 2 study testing LEO 124249 ointment in people with Chronic Hand Eczema, run by LEO Pharma at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- LEO 124249 ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, 10117
About this study
Official title: A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
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
- Being tested
- LEO 124249 ointment, LEO 124249 ointment vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 124249 ointmentDrug
Ointment
LEO 124249 ointment vehicleDrug
Ointment vehicle
| Study group | Role | What they receive |
|---|---|---|
| LEO 124249 ointment | Active comparator | Twice daily cutaneous application for 8 weeks Receives: Drug: LEO 124249 ointment |
| LEO 124249 ointment vehicle | Placebo comparator | Twice daily cutaneous application for 8 weeks Receives: Drug: LEO 124249 ointment vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 56 days
Secondary outcomes (2)
Hand Eczema Severity Index (HECSI) at visit 6
Measured: 56 days
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
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hand EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margitta Worm, Prof Dr, Principal investigator, Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664805
- Sponsor's protocol ID
- LP0133-1180
- Other IDs
- 2015-002079-11, 2015
- Status last verified
- Mar 2018
- First submitted
- 22 Jan 2016
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
- ClinicalTrials.gov ID
- NCT02664805
- Acronym / sponsor ID
- LP0133-1180
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 124249 ointment | Active comparator | Drug: LEO 124249 ointmentTwice daily cutaneous application for 8 weeks |
| LEO 124249 ointment vehicle | Placebo comparator | Drug: LEO 124249 ointment vehicleTwice daily cutaneous application for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 124249 ointmentOintment | Drug | LEO 124249 ointment |
| LEO 124249 ointment vehicleOintment vehicle | Drug | LEO 124249 ointment vehicle |
Primary outcome
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
2 secondary outcomes
Hand Eczema Severity Index (HECSI) at visit 6
Time frame: 56 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- LEO Pharma Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margitta Worm, Prof Dr principal investigator
Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 124249 ointment in people with Chronic Hand Eczema, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment) (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.