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

Psoriasis Clinical Trial

Official title:

EFFICACY AND SAFETY OF ACITRETIN IN DOSES OF 25mg,35mg or50mg IN PATIENTS WITH SEVERE PLAQUE TYPE PSORIASIS: A RANDOMISED,DOUBLE BLIND , PARALLEL GROUP DOSE- RANGING STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039142
• Other study ID #: 12345
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2009
• Last updated: December 23, 2009
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2008
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
India	Post Graduate institute Of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy		12 weeks	No
Secondary	Frequency of adverse effects at 3 different doses of acitretin		12 weeks	Yes