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IRCT20140624018210N8 IRCT 2018-10-21 Iran University of Medical Sciences Evaluating the efficacy of Metformin with Isotretinoin in the treatment of acne Evaluating the efficacy of Metformin with Isotretinoin in the treatment of patient with acne or delayed acne 2018-05-04 anticipated 70 Complete https://irct.ir/trial/33698 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by each block.The randomization unit is individual and randomization's tool is a statistical software, Blinding description: In this study, the outcome assessor and participants have been blinded. The outcome assessor is people who are responsible for gathering data and outcome variables and does not know which participant received which drug. 3 Acne. Intervention 1: Intervention group: Metformin with a dose of 500 mg twice a day for 6 months will be taken along with other prescribed medicines. Intervention 2: Control group: Oral isotretinoin will be taken a dose of 20 mg twice a day for 6 months along with other prescribed medicines. Yes - There is a plan to make this available What will be shared: Findings of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables When: Availability 6 months after the end of study To whom: Dermatology Conditions: In the case of comparison with other similar trials or treatment Where to obtain: Iran University of Medical Sciences How to obtain: By referring to the central library of Iran University of Medical Sciences can access to the text of the final report or article. Comments:
public Elham Behrangi
Rasoul- E Akram Hospital, Niayesh St, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1313114456 +98 21 6435 2421 behrangi.e@iums.ac.ir Iran University of Medical Sciences scientific Elham Behrangi
Rasoul-E Akram Hospital, Niayesh Str, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1313114456 +98 21 6435 2321 behrangi.e@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Start acne from adolescence and continue acne until the age of 25 Start acne from adolescence and continue after 25 years Start acne after 25 years 25 years 50 years Both History of taking Metformin or Isotretinoin History of chronic diseases of kidney, liver or heart L70 Acne Treatment - Drugs Treatment - Drugs Intervention group: Metformin with a dose of 500 mg twice a day for 6 months will be taken along with other prescribed medicines. Control group: Oral isotretinoin will be taken a dose of 20 mg twice a day for 6 months along with other prescribed medicines. Changes of acne severity. Timepoint: 1, 3 and 6 months after intervention. Method of measurement: Clinical examination. Fasting blood sugar. Timepoint: Before starting the intervention and 6 months after the intervention. Method of measurement: Blood test. Cholesterol. Timepoint: Before starting the intervention and 6 months after the intervention. Method of measurement: Blood test. Triglyceride. Timepoint: Before starting the intervention and 6 months after the intervention. Method of measurement: Blood test. Iran University of Medical Sciences Approved 2018-09-12 Ethics committee of Iran University of Medical Siences Iran University of Medical Siences, Shahid Hemmat highway Tehran Tehran Iran (Islamic Republic of)