MedDataX Logo

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

NCT ID: NCT01039142

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

25 mg acitretin

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

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type 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

35 mg acitretin

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

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type 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

50 mg acitretin

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

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Postgraduate Institute of Medical Education and Research

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sunil Dogra, MD

Role: STUDY_CHAIR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Post Graduate institute Of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12345

Identifier Type: -

Identifier Source: org_study_id