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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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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2016091918607N2 |
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Date of registration:
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2017-02-28 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the efficacy of NBUVB (narrow band UVB) phototherapy plus pioglitazone versus NBUVB phototherapy alone in the treatment of plaque type psoriasis
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Scientific title:
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Clinical trial of comparison of the efficacy of NBUVB phototherapy plus pioglitazone versus NBUVB phototherapy alone in the reduction of PASI score in patients with plaque type psoriasis |
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Date of first enrolment:
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2016-11-01 |
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Target sample size:
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74 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/16831 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Maryam Ghiasi
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Address:
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Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 5561 8989 |
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Email:
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mghiasi@tums.ac.ir |
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Affiliation:
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Tehran University of Medical Sciences, Department of Dermatology |
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Name:
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Maryam Ghiasi
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Address:
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Razi Hospital, Vahdat Eslami Sq, Tehran, Iran
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 5561 8989 |
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Email:
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mghiasi@tums.ac.ir |
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Affiliation:
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Department of Dermatology, Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: patients with plaque type psoriasis; indication of NBUVB phototherapy
Exclusion criteria: age under 18 years; treatment with phototherapy or systemic drugs of psoriasis during the last 3 months; pregnancy; lactation; congestive heart failure; renal diseases; liver diseases; pulmonary diseases
Exclusion criteria:
Age minimum:
no limit
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psoriasis.
Plaque psoriasis
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Plaque psoriasis
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Intervention(s)
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Placebo group: NBUVB three times a week plus placebo (the same as pioglitazone)
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Intervention 1: Pioglitazone group: NBUVB phototherapy three times a week plus pioglitazone (tablet 30 mg, 1 tab/ day, oral). Intervention 2: Placebo group: NBUVB three times a week plus placebo (the same as pioglitazone).
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Pioglitazone group: NBUVB phototherapy three times a week plus pioglitazone (tablet 30 mg, 1 tab/ day, oral)
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Treatment - Drugs
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Primary Outcome(s)
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PASI 75. Timepoint: Before treatment and 10 weeks after starting treatment. Method of measurement: Examination.
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Secondary Outcome(s)
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Adverse effects. Timepoint: every month after starting treatment. Method of measurement: examination and asking from the patients.
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Dermatology Life Quality Index (DLQI). Timepoint: Before treatment and 10 weeks after starting treatment. Method of measurement: Questionnaire.
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Source(s) of Monetary Support
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Tehran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Tehran University of Medical Sciences
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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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