A Phase 4 interventional study of Acitretin in Psoriasis, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-24.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 4, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 61 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
capsule acitretin 25 mg/day will be administered to each patient for a period of 12 weeks
Drug: Acitretin
capsule acitretin 35 mg/day will be administered to each patient for a period of 12 weeks
Drug: Acitretin
capsule acitretin 50 mg/day will be administered to each patient for a period of 12 weeks
Drug: Acitretin
capsule acitretin in dose of 25 mg, 35 mg or 50 mg/ day for 12 weeks or reduction in PASI score by 75% whichever is earlier
Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy
Time frame: 12 weeks
Frequency of adverse effects at 3 different doses of acitretin
Time frame: 12 weeks
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh