Hand EczemaPhase 3ALICsANCT03026946
Alitretinoin vs Cyclosporine in Severe Recurrent Vesicular Hand Eczema
A Phase 3 study testing Alitretinoin and cyclosporin A 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 cyclosporine in the treatment of patients with severe recurrent vesicular 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 cyclosporin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 May 2017to Jul 2022
- 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 recurrent vesicular 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 contact 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
- Treated with alitretinoin or cyclosporine in the previous 3 months
- Other morphologic types of hand eczema as defined by the Danish Contact Dermatitis Group
- Patients with predominantly atopic dermatitis, in which the hands are also involved. (Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion.)
- Psoriasis of the hands
- Active bacterial, fungal, or viral infection of the hands
Show all 35Show 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
- Uncontrolled arterial hypertension (minimally 3 measurements). Systolic pressure > 160 mmHg or diastolic pressure > 95 mmHg, despite starting anti-hypertensive medication (first choice amlodipine 5 mg/day)
- 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
- Evidence of alcohol abuse or drug addiction
- Malabsorption
- Currently active gout
- Recurring convulsions / epilepsy
- 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
- 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)
- Cyclosporine specific:
- Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician)
- Uremia
- Hyperkalemia
- Hyperuricemia in patients with a medical history of gout
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 Cyclosporine in Patients With Severe Recurrent Vesicular 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 cyclosporine in the treatment of patients with severe recurrent vesicular hand eczema.
- Conditions
- Hand Eczema
- Being tested
- Alitretinoin, cyclosporin A
- Keywords
- Alitretinoin, Cyclosporine A, 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.
cyclosporin ADrug
Also called Neoral
Oral cyclosporine A start dose 5 mg/kg/day (split in 2 doses), decreasing the dose after 8 weeks to 3 - 3.5 mg/kg/day (split in 2 doses). The treatment period is 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alitretinoin | Active comparator | Patients with severe recurrent vesicular hand eczema, randomized to treatment with alitretinoin. Receives: Drug: Alitretinoin |
| Cyclosporin A | Active comparator | Patients with severe recurrent vesicular hand eczema, randomized to treatment with cyclosporin A. Receives: Drug: cyclosporin A |
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 start29 May 2017
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
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 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- 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
- NCT03026946
- Sponsor's protocol ID
- 54659
- Acronym
- ALICsA
- Status last verified
- Feb 2019
- First submitted
- 13 Dec 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published anonymously and will not be possible to trace back to individual participants.
Publications
Oosterhaven JAF, Schuttelaar MLA. Study protocol: efficacy of oral alitretinoin versus oral cyclosporine A in patients with severe recurrent vesicular hand eczema (ALICsA): a randomised prospective open-label trial with blinded outcome assessment. BMJ Open. 2018 Jul 11;8(7):e020192. doi: 10.1136/bmjopen-2017-020192.
PubMed 29997136
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Alitretinoin Versus Oral Cyclosporine in Patients With Severe Recurrent Vesicular Hand Eczema. A Randomized Prospective Open-label Trial With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT03026946
- Acronym / sponsor ID
- ALICsA / 54659
- Conditions
- Hand Eczema
- Keywords
- Alitretinoin, Cyclosporine A, Hand eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 29 May 2017 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (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 cyclosporine in the treatment of patients with severe recurrent vesicular 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 recurrent vesicular hand eczema, randomized to treatment with alitretinoin. |
| Cyclosporin A | Active comparator | Drug: cyclosporin APatients with severe recurrent vesicular hand eczema, randomized to treatment with cyclosporin A. |
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 recurrent vesicular 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 contact 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 (35 listed)
- General criteria prior to randomization
- Treated with alitretinoin or cyclosporine in the previous 3 months
- Other morphologic types of hand eczema as defined by the Danish Contact Dermatitis Group
- Patients with predominantly atopic dermatitis, in which the hands are also involved. (Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion.)
- Psoriasis of 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 |
|---|---|---|
| AlitretinoinAlso: Toctino, 9-cis-retinoic acid, ATC code: D11AH04Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks. | Drug | Alitretinoin |
| cyclosporin AAlso: NeoralOral cyclosporine A start dose 5 mg/kg/day (split in 2 doses), decreasing the dose after 8 weeks to 3 - 3.5 mg/kg/day (split in 2 doses). The treatment period is 24 weeks. | Drug | Cyclosporin A |
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 26 Feb 2019.
- Derived from this study: PubMed 29997136Oosterhaven JAF, Schuttelaar MLA. Study protocol: efficacy of oral alitretinoin versus oral cyclosporine A in patients with severe recurrent vesicular hand eczema (ALICsA): a randomised prospective open-label trial with blinded outcome assessment. BMJ Open. 2018 Jul 11;8(7):e020192. doi: 10.1136/bmjopen-2017-020192.
- Individual participant dataSharing planned: No. Data will be published anonymously and will not be possible to trace back to individual participants.
Related trials for Hand Eczema
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingObservational study
PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry
Chronic Hand Eczema
Enrolling by invitationObservational study
Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
Chronic Hand Eczema (CHE)
RecruitingObservational study
Characterization of Chronic Hand Eczema
Chronic Hand Eczema, Atopic Dermatitis
Active, not recruitingObservational study
Methotrexat to Hand Eczema in the BIOSKIN Cohort
Atopic Dermatitis, Contact Dermatitis
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 cyclosporin A 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 35 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 26 Feb 2019. 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?
On the ClinicalTrials.gov record for NCT03026946, 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 26 Feb 2019.