Hand EczemaPhase 2NCT00404196
LEO19123 Cream in the Treatment of Hand Eczema
A Phase 2 study testing Calcipotriol and LEO80122 (LEO19123 cream) in people with Hand Eczema, run by LEO Pharma at 1 site in United Kingdom.
Trial summary
To compare the efficacy and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hand Eczema
- What is being tested?
- Calcipotriol and LEO80122 (LEO19123 cream)
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to Mar 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hand eczema with or without atopic etiology/background
- Investigator.s Global Assessment of disease severity graded as at least mild at Visit 1
- Patients should be Caucasian males aged from 18 years
- Attending a hospital outpatient clinic or the private practise of a dermatologist.
- Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods.
Who cannot join
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used).
- PUVA or UVB therapy on the hands within 4 weeks prior to randomisation.
- Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV on the hands within 2 weeks prior to randomisation.
- Other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation.
- Use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient.
- Concurrent skin diseases on the hands.
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- Current diagnosis of exfoliative dermatitis.
- Significant clinical infection (impetiginised hand eczema) on the hands, which requires antibiotic treatment.
- Known or suspected hypersensitivity to component(s) of the investigational product.
- Positive patch test as defined in protocol
- Known or suspected severe renal insufficiency or severe hepatic disorders.
- Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia.
- Patients with history of cancer except for basal cell carcinoma.
- Current participation in any other interventional clinical trial.
- Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.
- Previously randomised in this study.
- Patients known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
Trial locations and contacts
1 site in 1 country.
About this study
To compare the efficacy and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.
- Conditions
- Hand Eczema
- Being tested
- Calcipotriol and LEO80122 (LEO19123 cream)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol and LEO80122 (LEO19123 cream)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of concept
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startOct 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404196
- Sponsor's protocol ID
- LEO19123-C22
- Status last verified
- Aug 2007
- First submitted
- 27 Nov 2006
- Last updated
- 24 Feb 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO19123 Cream in the Treatment of Hand Eczema
- ClinicalTrials.gov ID
- NCT00404196
- Acronym / sponsor ID
- LEO19123-C22
- Conditions
- Hand Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 28 Nov 2006 (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 and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of hand eczema with or without atopic etiology/background
- Investigator.s Global Assessment of disease severity graded as at least mild at Visit 1
- Patients should be Caucasian males aged from 18 years
- Attending a hospital outpatient clinic or the private practise of a dermatologist.
- Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods.
Key exclusion criteria (17 listed)
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used).
- PUVA or UVB therapy on the hands within 4 weeks prior to randomisation.
- Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV on the hands within 2 weeks prior to randomisation.
- Other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation.
- Use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient.
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 |
|---|---|---|
| Calcipotriol and LEO80122 (LEO19123 cream) | Drug | – |
Primary outcome
Proof of concept
1 secondary outcome
Safety
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 24 Feb 2025.
- 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.
Medical Expert study director
LEO Pharma
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 Calcipotriol and LEO80122 (LEO19123 cream) in people with Hand Eczema, run by LEO Pharma at 1 site in United Kingdom.
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 5 inclusion and 17 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 24 Feb 2025. 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 United Kingdom. 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. 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?
Proof of concept. 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 24 Feb 2025.