Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: Acitretin

Study type: Interventional

Funder types: Other

Identifiers

NCT01039142

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Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with plaque-type psoriasis having <90%of body surface area involvement, whose disease activity had been stable for the last 1month.
• Age range 18-65 years of either sex
• Females who are postmenopausal or tubectomised or have completed their family and are willing to maintain contraception 1 month before, during and 2 years after completion of treatment and negative pregnancy tests within 2 months of starting of treatment.
• Compliance for scheduled visit.

Exclusion criteria

• Patients with severe hepatic, renal or other systemic disorders (serum bilirubin,AST,ALT and alkaline phosphatase>1.5 times upper limit of normal;serum creatinine >1.5 mg% in males and >1.4mg% in females)
• Pregnant or lactating women,contemplating pregnancy in next 2 -3 years
• Alcoholic
• Metabolic disorders such as hyperlipidemia
• Obese/BMI≥ 30 kg/m2
• Ischemic heart diseases,neuropsychiatric illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 3 patient groups

25 mg acitretin

Active Comparator group

Description:

capsule acitretin 25 mg/day will be administered to each patient for a period of 12 weeks

Treatment:

Drug: Acitretin

35 mg acitretin

Active Comparator group

Description:

capsule acitretin 35 mg/day will be administered to each patient for a period of 12 weeks

Treatment:

Drug: Acitretin

50 mg acitretin

Active Comparator group

Description:

capsule acitretin 50 mg/day will be administered to each patient for a period of 12 weeks

Treatment:

Drug: Acitretin