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IRCT20230324057772N1 IRCT 2023-03-29 Tehran University of Medical Sciences Stem cell derived topical serum for patients with vitiligo Evaluation therapeutic effect of conditioned medium from 3D culture mesenchymal stem cell spheroids serum for Vitiligo: clinical trial phase 1 2023-06-22 anticipated 20 Complete https://irct.ir/trial/69275 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, this method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = Active, Tails = Placebo. Implementation and treatment of assignments are completely unpredictable, Blinding description: Only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over. 1 Vitiligo. Intervention 1: Intervention group: The intervention group will receive a topical serum containing 3% adipose-derived mesenchymal stem cell medium, twice a day for 45 days. Intervention 2: Control group: the group will be received topical serum which is standard care containing: corticosteroid and vitamin D, without adipose derived mesenchymal stem cell conditioned medium, twice a day for 45 days. Yes - There is a plan to make this available What will be shared: All data collected for the primary outcome When: Data relative to the time after finishing the data collection and 3 months after publication To whom: Available for people working in an academic institution Conditions: There are no specific criteria Where to obtain: People can send an email to the responsible person (Dr. Mahsa Mollapour Sisakht) to get more information How to obtain: After requesting the data, you will get an email with the information (Email address: mahsamollapour@gmail.com) Comments:
public Mahsa Mollapour Sisakht
No.41, Italy St.
Tehran Iran (Islamic Republic of) 1417755354 +98 21 4462 0324 Mahsamollapour@gmail.com Tehran University of Medical Sciences scientific Mahsa Mollapour Sisakht
No.41, Italy St.
Tehran Iran (Islamic Republic of) 1417755354 +98 21 4462 0324 Mahsamollapour@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 18 Years and older Diagnosis of Vitiligo - Generalized vitiligo involving both sides of the body in one or more areas of the body (limbs, trunk, etc.) Be able to understand the requirements of the study and be able to sign an informed consent form Agree to follow the terms of the study and follow-up Lack of corticosteroid-based treatment no limit no limit Both Pregnant females Infection in donor site Kubner's evidence in the past Keloidal tendency Patients with focal or segmental vitiligo are defined as vitiligo that affects only one area of the body on one side of the body Patients with vitiligo that affects more than 30% of their body surface Patients who self-reported HIV or hepatitis C Patients self-reported having uncontrolled diabetes mellitus L80 Vitiligo Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive a topical serum containing 3% adipose-derived mesenchymal stem cell medium, twice a day for 45 days. Control group: the group will be received topical serum which is standard care containing: corticosteroid and vitamin D, without adipose derived mesenchymal stem cell conditioned medium, twice a day for 45 days Evaluation of skin repigmentation through skin biometry. Timepoint: Before and after of inerventation and 3 months after study completion. Method of measurement: Skin Biometry by using MPA9 probe. Tehran University of Medical Sciences Approved 2023-03-12 Ethics committee of Tehran University of Medical Sciences 6th floor, Qods Ave., Keshavarz Blvd., Tehran University of Medical Sciences, Central building Tehran Tehran Iran (Islamic Republic of)