Chronic Hand EczemaPhase 1NCT05486117
Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema
A Phase 1 study testing Delgocitinib in people with Chronic Hand Eczema, run by LEO Pharma at 1 site in Germany.
Trial summary
The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema. Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Delgocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2022to 22 Nov 2022
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above at screening.
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
- Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
Who cannot join
- Concurrent skin diseases on the hands, e.g. tinea manuum.
- Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
- Active psoriasis on any part of the body.
- Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
- Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
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- Use of tanning beds, phototherapy (e.g. ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen ultraviolet A [PUVA]), or bleach baths on the hands within 28 days prior to baseline.
- Cutaneously applied treatment with immunomodulators (e.g. phosphodiesterase 4 [PDE-4] inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.
- Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
- Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Twice-daily Applications of Delgocitinib Cream 20 mg/g for 1 Week in Adult Subjects With Moderate to Severe Chronic Hand Eczema.
The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema.
Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream.
The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.
- Conditions
- Chronic Hand Eczema
- Being tested
- Delgocitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
Cream for topical application 20 mg/g
| Study group | Role | What they receive |
|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | Twice-daily topical application for 8 days Receives: Drug: Delgocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12).
Measured: 0-12 hours post dose at Day 1 and Day 8
Maximum observed concentration (Cmax) at Day 1 and at Day 8 (0-12 hours post-dose).
Measured: Day 1 and at Day 8 (0-12 hours post-dose)
Secondary outcomes (3)
Time to reach maximum observed concentration (tmax) at Day 1 and Day 8 (0-12 hours post-dose).
Measured: Day 1 and Day 8 (0-12 hours post-dose).
Terminal elimination half-life (t1/2) at Day 8.
Measured: Day 8.
Number of treatment-emergent adverse events (AEs) from baseline to Day 22 per subject.
Measured: Baseline to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start6 Sep 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486117
- Sponsor's protocol ID
- LP0133-2285
- Other IDs
- 2022-000782-40, U1111-1284-2254
- Status last verified
- Jan 2022
- First submitted
- 18 Jul 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thaci D, Gooderham M, Lovato P, Madsen DE, Soehoel A, Bissonnette R. Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema. J Eur Acad Dermatol Venereol. 2025 Sep;39(9):1612-1621. doi: 10.1111/jdv.20777. Epub 2025 Jun 17.
PubMed 40525591
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Twice-daily Applications of Delgocitinib Cream 20 mg/g for 1 Week in Adult Subjects With Moderate to Severe Chronic Hand Eczema.
- ClinicalTrials.gov ID
- NCT05486117
- Acronym / sponsor ID
- LP0133-2285
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 3 Aug 2022 (actual)
- 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.
The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema.
Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream.
The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | Drug: DelgocitinibTwice-daily topical application for 8 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or above at screening.
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
- Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
Key exclusion criteria (10 listed)
- Concurrent skin diseases on the hands, e.g. tinea manuum.
- Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
- Active psoriasis on any part of the body.
- Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
- Clinically significant infection (e.g. impetiginised hand eczema) 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 |
|---|---|---|
| DelgocitinibCream for topical application 20 mg/g | Drug | Delgocitinib cream 20 mg/g |
Primary outcome
Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12).
Time frame: 0-12 hours post dose at Day 1 and Day 8
Maximum observed concentration (Cmax) at Day 1 and at Day 8 (0-12 hours post-dose).
Time frame: Day 1 and at Day 8 (0-12 hours post-dose)
3 secondary outcomes
Time to reach maximum observed concentration (tmax) at Day 1 and Day 8 (0-12 hours post-dose).
Time frame: Day 1 and Day 8 (0-12 hours post-dose).
Terminal elimination half-life (t1/2) at Day 8.
Time frame: Day 8.
Number of treatment-emergent adverse events (AEs) from baseline to Day 22 per subject.
Time frame: Baseline to Day 22
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 4 Apr 2025.
- Derived from this study: PubMed 40525591Thaci D, Gooderham M, Lovato P, Madsen DE, Soehoel A, Bissonnette R. Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema. J Eur Acad Dermatol Venereol. 2025 Sep;39(9):1612-1621. doi: 10.1111/jdv.20777. Epub 2025 Jun 17.
- 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 1 study testing Delgocitinib 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 5 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 4 Apr 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12). (time frame: 0-12 hours post dose at Day 1 and Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486117, which also lists 1 linked publication.
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 4 Apr 2025.