Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00811005 |
| Other study ID # |
2006-004519-23 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 3
|
| First received |
December 17, 2008 |
| Last updated |
September 17, 2009 |
| Start date |
October 2008 |
| Est. completion date |
October 2010 |
Study information
| Verified date |
September 2009 |
| Source |
Medical University of Vienna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Austria: Ethikkommission |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this prospective, randomized, controlled, single-blinded investigation is to
study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with
acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with
pustular palmoplantar psoriasis.
Patients will be randomized and allocated in concealed manner to one of the two treatment
arms: acitretin-PUVA or FAE-PUVA.
Description:
Acitretin-PUVA treatment schedule:
Acitretin monotherapy: Patients randomized to the acitretin group will receive acitretin in
a dose of 1mg /kg daily two weeks prior to additional PUVA treatment.
Acitretin-PUVA combination: PUVA treatment (see below) will be applied thrice weekly in
addition to acitretin until (near) complete clearance or over a maximum period of 12 weeks.
(Near) complete clearance is defined by improvement of the clinical baseline score (see
below) by ≥90%.
Acitretin maintenance therapy: After (near) complete clearance patients will be continued on
a maintenance dose of 0.5 mg/kg acitretin over 6 months or until significant relapse.
Significant relapse is defined by a worsening of the clinical score to ≥50 % of the baseline
score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of
the baseline score) will be followed up until significant relapse or over a maximum period
of 12 months.
Besides emollients no additional specific treatments will be allowed during the study.
FAE-PUVA treatment schedule:
FAE monotherapy: Patients randomized to this group will receive FAE in weekly incremental
doses (initial daily dose: 30 mg dimethylfumarate (DMF), highest daily dose: 720 mg DMF)
starting two weeks prior to additional PUVA treatment.
FAE-PUVA combination: PUVA treatment will be applied thrice weekly in addition to FAE until
(near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is
defined by improvement of the clinical baseline score (see below) by ≥90%.
FAE maintenance therapy: After (near) complete clearance FAE will be reduced weekly by 120
mg DMF to a daily maintenance dose of 360 mg DMF which will be administered for a maximum
period of 6 months or until significant relapse. Significant relapse is defined by a
worsening of the clinical score to ≥50 % of the baseline score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of
the baseline score) will be followed up until significant relapse or over a maximum period
of 12 months.
Besides emollients no additional specific treatments will be allowed during the study.
PUVA treatment:
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case
of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before
UVA irradiation.
Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be
given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure
will be limited to the hands and feet.
Primary outcome measure:
Duration of remission
Secondary outcome measures:
Percentage of patients achieving remission Number of PUVA exposures required for inducing
remission Total UVA exposure dose required for inducing remission Frequency and quality of
adverse reactions
Assessment of clinical response:
A modified local PASI (psoriasis area and severity index) score adapted for the evaluation
of the hands and feet will be performed by a blinded investigator at baseline and the onset
of PUVA treatment, in biweekly intervals during the course of PUVA treatment, in monthly
intervals after discontinuation of PUVA and in bimonthly intervals during a 1-year follow-up
period. The study will be terminated in case of a significant relapse which is defined by a
PASI score of ≥50 % of the baseline score.
Monitoring:
Prior to the study the blood chemistry, complete blood cell count including differential,
urine analysis, TSH, TPO- and TG autoantibodies, a pregnancy tests (in women of childbearing
potential) and an ophthalmological examination will be performed. During the study the
complete blood cell count, blood chemistry, urine analysis and pregnancy test (in women of
childbearing potential) will be reexamined monthly.
