Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
In this study, the investigators will intend to compare the efficacy and safety of various
doses of acitretin in a randomized double blind manner in patients with severe plaque-type
psoriasis, by i) studying the change PASI score from baseline as a measure of efficacy ii)
determining the frequency of side effects at various doses. Sixty patients will be recruited
from Psoriasis Clinic of Department of Dermatology, Venerology and Leprology, PGIMER.
Patients will be randomly assigned to one of the three groups: Group A, consisting of 20
patients, will be administered acitretin 25 mg/ day ,Group B, consisting of 20 patients, will
be administered acitretin 35 mg/day and GROUP C consisting of 20 patients, will be
administered acitretin 50 mg/day This therapy will be continued until PSORIASIS AREA AND
SEVERITY INDEX (PASI) scores are reduced to < 25% of the original scores or 12 weeks,
whichever comes earlier. It is expected that acitretin at higher doses will be more
efficacious . As the exact etiopathogenesis of psoriasis is not fully known, it is difficult
to provide a definite cure to all patients, though the disease activity can be controlled to
a great extent with various treatment modalities. However the dosage of acitretin be adjusted
according to response of the patients and tolerability of side effects.
Phase:
Phase 4
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research