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

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01039142
First received: December 23, 2009
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Psoriasis
 Drug: Acitretin
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Acitretin
U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Change in Psoriasis area severity index from baseline to 12 weeks after acitretin therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of adverse effects at 3 different doses of acitretin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 25 mg acitretin
capsule acitretin 25 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
Active Comparator: 35 mg acitretin
capsule acitretin 35 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
Active Comparator: 50 mg 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039142

Locations
India
Post Graduate institute Of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Study Chair: Sunil Dogra, MD Post Graduate Institute of Medical Education And Research
  More Information

No publications provided

Responsible Party: Dr Aklish Jain, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01039142     History of Changes
Other Study ID Numbers: 12345
Study First Received: December 23, 2009
Last Updated: December 23, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Acitretin
 Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013