Hand EczemaPhase 3ALIAZNCT03026907
Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema
A Phase 3 study testing Alitretinoin and Azathioprine in people with Hand Eczema, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the treatment of patients with severe chronic non-hyperkeratotic hand eczema. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hand Eczema
- What is being tested?
- Alitretinoin and Azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2016to Dec 2019
- Phase
- Phase 3
- 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 and ≤ 75 years
- Severe or very severe chronic non-hyperkeratotic hand eczema for a minimum duration of 3 months as defined by a Physician Global Assessment (PGA) using a validated Photoguide
- Refractory to standard therapy, defined as:
- Patients received treatment with topical corticosteroids of class II or higher for at least 8 weeks within 3 months before enrolment, with either no response or a transient response. Patients had also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement. Patients had avoided irritants and allergens, if identified, without significant improvement.
- Women of childbearing potential are required to use at least two forms of contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after finishing treatment; these women are required to take monthly pregnancy tests
- Able to provide written Informed Consent
- Able to speak and read the Dutch language
Who cannot join
- General criteria prior to randomization
- Treatment with alitretinoin or azathioprine in the previous 3 months
- Hyperkeratotic palmar eczema as defined by the Danish Contact Dermatitis Group
- Patients with predominantly atopic dermatitis, in which the hands are also involved. Patients with mild atopic dermatitis, in which the hands are mainly affected are eligible for inclusion.
- Psoriasis
- Active bacterial, fungal, or viral infection of the hands
Show all 30Show fewer
- Pregnant/lactating or planning to become pregnant during the study period
- Treatment with systemic medication or UV radiation within the previous 4 weeks
- Mentally incompetent
- Immunocompromised status
- Known or suspected allergy to ingredients in the study medications
- Inclusion in a study of an investigational drug within 60 days prior to start of treatment
- Current malignancy (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and⁄or localized carcinoma in situ of the cervix)
- Current active pancreatitis
- Living vaccine (including bacillus Calmette-Guérin (BCG), varicella, measles, mumps, rubella, yellow fever, oral polio and oral typhoid) in the last 2 weeks or the planned application of such a vaccine during the study period
- Evidence of alcohol abuse or drug addiction
- Chronic or recurrent infectious diseases
- Contact sensitizations with clinical relevance to the hands, in which exposure to allergens is not avoided
- Hypervitaminosis A due to the use of vitamin A supplements containing >2000 IU
- Use of drugs with potential to change the effective dosis of study drugs within the previous 2 weeks
- Laboratory exclusion criteria post randomization
- Alanine aminotransferase (ALAT) and ⁄or aspartate aminotransferase (ASAT) values > 200% of the upper limit of normal
- Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician)
- Anemia as indicated by a clinically relevant lowered hemoglobin value (to be determined by investigator or treating physician)
- Alitretinoin specific
- Triglycerides > 200% of the upper limit of normal,
- Cholesterol or low density lipoprotein (LDL) cholesterol values > 200% of the upper limit of normal
- Uncontrolled hypothyroidism (to be determined by investigator or treating physician)
- Azathioprine specific
- Patients with low or absent thiopurine methyltransferase (TPMT) activity (defined in our center as <52 nmol/gHb/hour, combined with genotyping showing homozygous of compound heterozygous mutations) and a subsequent risk for life-threatening myelotoxicity
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700RB
MLA Schuttelaar, MD, PhD, +31503612520, m.l.a.schuttelaar@umcg.nl
JAF Oosterhaven, MD, +31503610795, j.a.f.oosterhaven@umcg.nl
About this study
Official title: Efficacy of Oral Alitretinoin Versus Oral Azathioprine in Patients With Severe Chronic Non-hyperkeratotic Hand Eczema. A Randomized Prospective Open-label Trial With Blinded Outcome Assessment
The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the treatment of patients with severe chronic non-hyperkeratotic hand eczema.
- Conditions
- Hand Eczema
- Being tested
- Alitretinoin, Azathioprine
- Keywords
- Alitretinoin, Azathioprine, Hand eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlitretinoinDrug
Also called Toctino, 9-cis-retinoic acid, ATC code: D11AH04
Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.
AzathioprineDrug
Also called Imuran, Azafalk, ATC code: L04AX01
Oral azathioprine tablets twice daily in a dose of 1.5 or 2.5mg/kg/day, depending on the thiopurine methyltransferase (TPMT) activity.
| Study group | Role | What they receive |
|---|---|---|
| Alitretinoin | Active comparator | Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin. Receives: Drug: Alitretinoin |
| Azathioprine | Active comparator | Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine. Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment/hand eczema severity (Photoguide)
Measured: 24 weeks (end of treatment)
Secondary outcomes (8)
Response to treatment/hand eczema severity (Photoguide)
Measured: 12 weeks
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
Measured: Week 4, 8, 12, 24
Time to response
Measured: Week 4, 8, 12, 24
Patient reported improvement (Patient Global Assessment, PaGA)
Measured: Week 12 and 24
Safety and tolerability (adverse events)
Measured: Up to 24 weeks
Cost-utility. QALY's: registered direct/indirect costs, combined with EQ-5D outcome
Measured: Week 12 and 24
Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (Photoguide/HECSI)
Measured: Week 12 and 24
Quality of Life: questionnaire.
Measured: Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Louise A Schuttelaar, MD, PhD, University Medical Center Groningen
- Investigators
- MLA Schuttelaar, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026907
- Sponsor's protocol ID
- 52232
- Acronym
- ALIAZ
- Status last verified
- May 2018
- First submitted
- 18 Aug 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published anonymously and will not be possible to trace back to individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Alitretinoin Versus Oral Azathioprine in Patients With Severe Chronic Non-hyperkeratotic Hand Eczema. A Randomized Prospective Open-label Trial With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT03026907
- Acronym / sponsor ID
- ALIAZ / 52232
- Conditions
- Hand Eczema
- Keywords
- Alitretinoin, Azathioprine, Hand eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Jan 2017 (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.
The purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the treatment of patients with severe chronic non-hyperkeratotic hand eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alitretinoin | Active comparator | Drug: AlitretinoinPatients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin. |
| Azathioprine | Active comparator | Drug: AzathioprinePatients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 75 years
- Severe or very severe chronic non-hyperkeratotic hand eczema for a minimum duration of 3 months as defined by a Physician Global Assessment (PGA) using a validated Photoguide
- Refractory to standard therapy, defined as:
- Patients received treatment with topical corticosteroids of class II or higher for at least 8 weeks within 3 months before enrolment, with either no response or a transient response. Patients had also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement. Patients had avoided irritants and allergens, if identified, without significant improvement.
- Women of childbearing potential are required to use at least two forms of contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after finishing treatment; these women are required to take monthly pregnancy tests
Key exclusion criteria (30 listed)
- General criteria prior to randomization
- Treatment with alitretinoin or azathioprine in the previous 3 months
- Hyperkeratotic palmar eczema as defined by the Danish Contact Dermatitis Group
- Patients with predominantly atopic dermatitis, in which the hands are also involved. Patients with mild atopic dermatitis, in which the hands are mainly affected are eligible for inclusion.
- Psoriasis
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 |
|---|---|---|
| AlitretinoinAlso: Toctino, 9-cis-retinoic acid, ATC code: D11AH04Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks. | Drug | Alitretinoin |
| AzathioprineAlso: Imuran, Azafalk, ATC code: L04AX01Oral azathioprine tablets twice daily in a dose of 1.5 or 2.5mg/kg/day, depending on the thiopurine methyltransferase (TPMT) activity. | Drug | Azathioprine |
Primary outcome
Response to treatment/hand eczema severity (Photoguide)
Time frame: 24 weeks (end of treatment)
8 secondary outcomes
Response to treatment/hand eczema severity (Photoguide)
Time frame: 12 weeks
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
Time frame: Week 4, 8, 12, 24
Time to response
Time frame: Week 4, 8, 12, 24
Patient reported improvement (Patient Global Assessment, PaGA)
Time frame: Week 12 and 24
Safety and tolerability (adverse events)
Time frame: Up to 24 weeks
Cost-utility. QALY's: registered direct/indirect costs, combined with EQ-5D outcome
Time frame: Week 12 and 24
Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (Photoguide/HECSI)
Time frame: Week 12 and 24
Quality of Life: questionnaire.
Time frame: Week 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: No. Data will be published anonymously and will not be possible to trace back to individual participants.
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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.
MLA Schuttelaar, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alitretinoin and Azathioprine in people with Hand Eczema, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 4 May 2018. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MLA Schuttelaar, MD, PhD (+31503612520, m.l.a.schuttelaar@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment/hand eczema severity (Photoguide) (time frame: 24 weeks (end of treatment)). 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 4 May 2018.