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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00395941 |
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Date of registration:
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03/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
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Scientific title:
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Date of first enrolment:
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December 2006 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00395941 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Sunil Dogra, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Postgraduate Institute of Medical Education and Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with chronic plaque type psoriasis having body surface area involvement of >
20%
- Patients of either sex
- Females who have completed their family and are tubectomized or are postmenopausal
i.e. no menstrual bleeding over at least 1 year
- Age range 18-65 years
Exclusion Criteria:
- Females of child bearing potential
- H/O hypersensitivity to acitretin
- Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase >1.5
times the upper limit of normal)
- Impaired renal function (serum creatinine >1.5mg% in males and >1.4 mg% in females)
- Hyperlipidemia
- BMI >30 kg /m2
- H/O excessive alcohol use
- Diabetes mellitus
- Congestive heart failure
- Ischemic heart disease
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Acitretin
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Drug: Pioglitazone
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Primary Outcome(s)
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Change in PASI score from baseline in the two groups
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12
[Time Frame: 12 weeks]
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Secondary ID(s)
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Pharma 6/699
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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