This study has been transitioned to CTIS with ID 2024-515140-23-00 check the CTIS register for the current data. To compare the efficacy of alitretinoin and cyclosporine in the treatment of hand eczema.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for efficacy is response to treatment, defined as
achieving *clear*/*almost clear* in the PGA (Physician Global Assessment)
score, based on a validated Photographic Guide developed by Coenraads et al
(16) at 24 weeks of treatment
Secondary outcome
Secondary endpoints are: improvement of >=2 steps on the PGA score, based on a
validated Photographic Guide developed by Coenraads et al at 24 weeks of
treatment; improvement in the Hand Eczema Severity Index (HECSI) score;
improvement in the Health related Quality of Life questionnaire for hand eczema
(QOLHEQ); and a Patient Global Assessement (PaGA) of improvement after 12 en 24
weeks. Adverse events will be registered, as well as time to response.
Furthermore, cost-utility, quality adjusted life years (QALYs) and
cost-effectiveness will be assessed with the EQ-5D-5L questionnaire while
monitoring treatment related costs.
Background summary
Hand eczema is a common condition, with a point prevalence of 4% and a
1-year-period prevalence up to 10% in the general population.
Systemic treatment with alitretinoin is registered for all clinical types of
hand eczema. However, it is especially effective in hyperkeratotic subtype, and
less effective in non-hyperkeratotic forms. Cyclosporine is often prescribed
'off-label' for hand eczema in daily practice and has a benefical effect in
recurrent vesicular hand eczema. However, there is no international consensus
on the classification of clinical types of hand eczema. The efficacy of
cyclosporine in hand eczema could prove superior to that of alitretinoin.
Study objective
This study has been transitioned to CTIS with ID 2024-515140-23-00 check the CTIS register for the current data.
To compare the efficacy of alitretinoin and cyclosporine in the treatment of
hand eczema.
Study design
Randomized prospective open-label trial with blinded outcome assessment, set in
a university dermatology clinic and at dermatology departments of other
hospitals in the Netherlands. The researchers of the dermatology department
from UMCG will include patients in UMCG or at dermatology departments of other
hospitals in the Netherlands. The other hospitals only have a facilitating
role. In this way, patients can be treated and included in the study at their
own hospital. Assessment of severity and laboratory measurements in this study
will be conducted correspondending to daily practice in our department.
Intervention
Group I: alitretinoin 30mg/day
Group II: cyclosporine 5mg/kg/day (startdose). After 8 weeks decreased to 3-3.5
mg/kg/day.
Treatment duration is 24 weeks.
Study burden and risks
This trial is designed in a way that minimizes the burden and risks for the
patient, because it will be carried out according to daily practice at our
department. Moreover, patients can be treated and included in the study at
their own hospital by the researchers of the dermatology department from UMCG
and therefore travel as little as possible. No additional laboratory
measurements will be carried out next to measurements that are routinely
assessed in treatment with one of both study drugs. Evaluation of cost-utility
and cost-effectiveness of both treatments is additional compared to daily
practice. A maximum of one extra visit is needed to give patients consideration
time before participation in the study. Results of the trial can be related to
the population of patients with moderate to very severe hand eczema.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years and <= 75 years
- Moderate, severe or very severe hand eczema for a minimum duration of 3
months as defined by a validated Photoguide
- Refractory to standard therapy, defined as:
o 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
o Patients had also received standard skin care, including emollients and
barrier protection as appropriate, without significant improvement
o 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
Exclusion criteria
- Treated with alitretinoin or cyclosporine in the previous 3 months
- 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
- Pregnant/lactating or planning to become pregnant during the study period
- Treatment with systemic medication or UV radiation within the previous 4
weeks. For systemic prednisolone; patients with treatment within the previous 2
weeks will be excluded
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-515140-23-00 |
| EudraCT | EUCTR2015-003488-12-NL |
| ClinicalTrials.gov | NCT03026946 |
| CCMO | NL54659.042.15 |