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

NCT01039142 | Completed Phase 4

• 1 other identifier: 12345
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy

  12 weeks

Secondary Outcomes (1)

• Frequency of adverse effects at 3 different doses of acitretin

  12 weeks

Study Arms (3)

25 mg acitretin

ACTIVE COMPARATOR

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

Drug: Acitretin

35 mg acitretin

ACTIVE COMPARATOR

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

Drug: Acitretin

50 mg acitretin

ACTIVE COMPARATOR

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

Drug: Acitretin

Interventions

Acitretin DRUG

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

25 mg acitretin; 35 mg acitretin; 50 mg acitretin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate institute Of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Sunil Dogra, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2008-02

Locations

IN (1)