Chronic Hand EczemaPhase 4NCT05682859
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
A Phase 4 study testing Roflumilast 500 Mcg Oral Tablet in people with Chronic Hand Eczema, run by Jacob Pontoppidan Thyssen at 1 site in Denmark.
Trial summary
This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension. The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Roflumilast 500 Mcg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Sep 2023to 1 Sep 2025
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Age ≤ 75 years
- HECSI ≥ 18 (moderate to severe hand eczema)
- IGA-CHE ≥ 3
- Body mass index (BMI) ≥ 20 kg/m2
- Negative pregnancy test (only women of child-bearing potential (see section 2.8))
- Willing to use safe anticonception during entire study and at least 1 week after end of treatment (-5 times plasma half-life of Roflumilast). This only account for women child-bearing potential
- Speaks, understands, and reads danish.
Who cannot join
- Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- Diagnosis of current tuberculosis
- Current viral hepatitis
- History of heart failure (NYHA III-IV)
- History of moderate or severe liver failure (Child-Pugh B-C)
- Current or former depression with suicidal ideation
Show all 18Show fewer
- Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization
- Topical therapy (anti-inflammatory) for chronic hand eczema during study
- Systemic therapy for chronic hand eczema 28 days before randomization
- Systemic therapy for chronic hand eczema during study
- Current treatment with oral dicloxacillin or macrolide
- Current treatment with topical antibiotics
- Diagnosis of contact eczema of clinical significance 3 months before randomization
- Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®)
- Confirmed pregnancy
- Breast feeding
- Blood donation during study
- Allergy to roflumilast or any other PDE-4 inhibitor
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of dermatology and veneorology, Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial
This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension.
The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE).
Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.
Read the detailed description
This study will investigate the efficacy and safety of roflumilast in adult patients with CHE and it is hypothesized that patients treated with oral roflumilast (500 microgram once daily) will experience an improvement in their moderate-to-severe CHE (measured by hand eczema severity index (HECSI)) and alter the skin microbiome. Secondly, it is hypothesized that patients treated with oral roflumilast will experience improved lung function and weight loss.
This study includes two phases:
Phase 1: 20 patients will receive 500 microgram tablet of roflumilast once daily for 16 weeks while 20 patients will receive placebo once daily for 16 weeks.
Phase 2: All 40 patients from phase 1 will receive 500 microgram tablet of roflumilast once daily for 12 weeks.
- Conditions
- Chronic Hand Eczema
- Being tested
- Roflumilast 500 Mcg Oral Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 500 Mcg Oral TabletDrug
Also called Daxas
Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Active comparator | 20 of the participating patients are randomized to the active arm where systemic roflumilast 500 microgram tablets are received. Receives: Drug: Roflumilast 500 Mcg Oral Tablet |
| Placebo | Placebo comparator | 20 of the participating patients are randomized to the active arm where systemic placebo tablets are received. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Measured: Through study completion, an average of 28 weeks
Secondary outcomes (17)
Proportion of patients achieving at least 50% reduction in baseline HECSI (HECSI50) at assessments.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Measured: Through study completion, an average of 28 weeks
Proportion of patients achieving at least 90% reduction in baseline HECSI (HECSI90) at assessments.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Measured: Through study completion, an average of 28 weeks
Proportion of patients achieving at least 100% reduction in baseline HECSI (HECSI100) at assessments
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Measured: Through study completion, an average of 28 weeks
Percent change from baseline in HECSI score at assessments.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Measured: Through study completion, an average of 28 weeks
Change (2 or more points) in physician global assessment for chronic hand eczema IGA-CHE) at assessments.
The IGA-CHE rates the severity of the patient's global disease assessed by the physician and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: Through study completion, an average of 28 weeks
Change from baseline in dermatology life quality index (DLQI) at assessments.
DLQI is a validated, self-administered, 10-item questionnaire that measure the impact of skin disease on patients' quality of life, based on recall over the past week. Domains include symptoms, feeling, daily activities, social, leisure, work or studying, personal relationships, and treatment. Each question is answered on a scale of 0 (not at all) to 3 (very much) and the total score may vary from 0 to 30.
Measured: Through study completion, an average of 28 weeks
Change from baseline in patient's global assessment (PaGA) at assessments.
The PaGA rates the severity of the patient's global disease assessed by the patient and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: Through study completion, an average of 28 weeks
Change from baseline in numeric rating scale (NRS) - Peak skin pain on hands within the last 24 hours at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Measured: Through study completion, an average of 28 weeks
Change from baseline in numeric rating scale (NRS) - Peak skin pain on hands within the last 7 days at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Measured: Through study completion, an average of 28 weeks
Change from baseline in NRS - Peak itch on hands within the last 24 hours at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Measured: Through study completion, an average of 28 weeks
Change from baseline in NRS - Peak itch on hands within the last 7 days at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Measured: Through study completion, an average of 28 weeks
Change from baseline in NRS - sleeplessness within the last 24 hours at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Measured: Through study completion, an average of 28 weeks
Change from baseline in NRS - sleeplessness within the last 7 at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Measured: Through study completion, an average of 28 weeks
Change from baseline in NRS - Patient treatment satisfaction within the last 7 at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient treatment satisfaction on a scale from 0 (very unsatisfied) to 10 (very satisfied).
Measured: Through study completion, an average of 28 weeks
Change from baseline in quality of life hand eczema questionnaire (QOLHEQ) at assessments.
QOLHEQ is a validated, self-administered 30-question questionnaire that measures impairment of health-related quality of life (HRQoL) in patients with HE. Domains include symptoms, emotions, functioning and treatment/prevention. 0 (not at all) to 4 (all the time) and the total score may vary from 0 to 120. A QOLHEQ score greater than 86 is indicative of very strong impairment.
Measured: Through study completion, an average of 28 weeks
Change from baseline in work productivity and activity impairment: CHE (WPAI:CHE) at assessments.
WPAI is a validated, self-administered questionnaire that measures the impact of CHE on work. Domains include time missed from work and impairment of work and regular activities due to CHE.
Measured: Through study completion, an average of 28 weeks
Adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARS) documented at assessments.
AE are any unfavorable and/or unintended sign or incident, symptoms or disease, whether related to roflumilast or placebo. This also includes laboratory results outside the reference range, though only laboratory results with clinical relevance will be examined. Any AE from the first administration of the trial medication to 8 days after the last administration of the trial medicine will be recorded, though unfavorable event reported in questionnaires will not be recorded as AE. SAE and SAR are any AE or adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly of birth defect.
Measured: Through study completion, an average of 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start25 Sep 2023
- Primary completion17 Jun 2025
- Study completion1 Sep 2025
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacob Pontoppidan Thyssen
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Sponsor-investigator, Jacob Pontoppidan Thyssen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682859
- Sponsor's protocol ID
- MC-HE-RO
- Other IDs
- 2022-503011-42-00
- Status last verified
- Jun 2025
- First submitted
- 16 Dec 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05682859
- Acronym / sponsor ID
- MC-HE-RO
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jacob Pontoppidan ThyssenUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 12 Jan 2023 (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.
This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension.
The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE).
Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.
Detailed description
This study will investigate the efficacy and safety of roflumilast in adult patients with CHE and it is hypothesized that patients treated with oral roflumilast (500 microgram once daily) will experience an improvement in their moderate-to-severe CHE (measured by hand eczema severity index (HECSI)) and alter the skin microbiome. Secondly, it is hypothesized that patients treated with oral roflumilast will experience improved lung function and weight loss.
This study includes two phases:
Phase 1: 20 patients will receive 500 microgram tablet of roflumilast once daily for 16 weeks while 20 patients will receive placebo once daily for 16 weeks.
Phase 2: All 40 patients from phase 1 will receive 500 microgram tablet of roflumilast once daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Active comparator | Drug: Roflumilast 500 Mcg Oral Tablet20 of the participating patients are randomized to the active arm where systemic roflumilast 500 microgram tablets are received. |
| Placebo | Placebo comparator | Drug: Placebo20 of the participating patients are randomized to the active arm where systemic placebo tablets are received. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Age ≤ 75 years
- HECSI ≥ 18 (moderate to severe hand eczema)
- IGA-CHE ≥ 3
- Body mass index (BMI) ≥ 20 kg/m2
Key exclusion criteria (18 listed)
- Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- Diagnosis of current tuberculosis
- Current viral hepatitis
- History of heart failure (NYHA III-IV)
- History of moderate or severe liver failure (Child-Pugh B-C)
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 |
|---|---|---|
| Roflumilast 500 Mcg Oral TabletAlso: DaxasRandomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2. | Drug | Roflumilast |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Proportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline.
Time frame: Through study completion, an average of 28 weeks
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
17 secondary outcomes
Proportion of patients achieving at least 50% reduction in baseline HECSI (HECSI50) at assessments.
Time frame: Through study completion, an average of 28 weeks
Proportion of patients achieving at least 90% reduction in baseline HECSI (HECSI90) at assessments.
Time frame: Through study completion, an average of 28 weeks
Proportion of patients achieving at least 100% reduction in baseline HECSI (HECSI100) at assessments
Time frame: Through study completion, an average of 28 weeks
Percent change from baseline in HECSI score at assessments.
Time frame: Through study completion, an average of 28 weeks
Change (2 or more points) in physician global assessment for chronic hand eczema IGA-CHE) at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in dermatology life quality index (DLQI) at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in patient's global assessment (PaGA) at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in numeric rating scale (NRS) - Peak skin pain on hands within the last 24 hours at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in numeric rating scale (NRS) - Peak skin pain on hands within the last 7 days at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - Peak itch on hands within the last 24 hours at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - Peak itch on hands within the last 7 days at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - sleeplessness within the last 24 hours at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - sleeplessness within the last 7 at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - Patient treatment satisfaction within the last 7 at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in quality of life hand eczema questionnaire (QOLHEQ) at assessments.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in work productivity and activity impairment: CHE (WPAI:CHE) at assessments.
Time frame: Through study completion, an average of 28 weeks
Adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARS) documented at assessments.
Time frame: Through study completion, an average of 28 weeks
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 6 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast 500 Mcg Oral Tablet in people with Chronic Hand Eczema, run by Jacob Pontoppidan Thyssen at 1 site in Denmark.
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 8 inclusion and 18 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 6 Aug 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline. (time frame: Through study completion, an average of 28 weeks). 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 6 Aug 2026.