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IRCT20221130056672N6 IRCT 2024-02-04 Tehran University of Medical Sciences Assessment of the effect of exosomes in the treatment of melasma Assessment of Safety and Efficacy of Intradermal Injection of Wharton's jelly Mesenchymal Cells Derived Extracellular Vesicles With CO2 Laser in Treatment of Melasma(A randomized controlled intervention study) 2024-04-03 anticipated 30 Complete https://irct.ir/trial/75086 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The people who are treated with CO2 laser are the people who have skin type below 5 and the people whose skin type is 5 and above are excluded from the plan and the laser is not performed for them, CO2 laser with low degree and low density And also the shots are done with less power and with a long distance. Taking into account the possibility of PIH and to prevent this issue, the skin type of the patients is examined first, and then the patients go to the skin center one week before the laser treatment and for them Kligman's combination, which includes 4 grams of hydroquinone, 0.1 grams of dexamethasone and 0.0025 grams of tretinoin, is used. It should be considered that in this plan, our main goal is to investigate the injection of exosomes derived from Wharton jelly mesenchymal cells for melasma disease and the use of CO2 laser with a low level is used for the purpose of the process to increase drug absorption and is used to increase permeability for exosome injection, Randomization description: Using the simple randomization method, the patients who visit Dr. Nilfroshzadeh's skin clinic are divided into 3 groups, so that one envelope is randomly selected for each patient from the number of 30 sealed envelopes. will be Inside each envelope is the letter A, B or C. Group A patients will be treated with CO2 laser(control group),group B will be treated with Injection of optimal amount of extracellular vesicles derived from Wharton's jelly mesenchymal cells along with CO2 laserand group C patients will be treated with Injection of optimal amount of extracellular vesicles derived from Wharton's jelly mesenchymal cells alone. 1-2 Melasma. Intervention 1: Control group: CO2 laser is performed as a routine treatment for melasma disease, so group A patients are treated using CO2 laser with a wavelength of 30 j and for 5 minutes in the skin and stem cell center by a specialist doctor and the duration of treatment is 4 sessions with an interval of 1 month. Intervention 2: Intervention group: Group B is treated by injecting the optimal amount of extracellular vesicles derived from Wharton jelly mesenchymal cells in one-to-one dimensions with a volume of 1 ml in the lesion area along with CO2 laser at the Skin and Hair Research Center. The duration of treatment is 4 sessions with an interval of 1 month. Intervention 3: Intervention group: Group C is treated by injecting the optimal amount of extracellular vesicles derived from Wharton's jelly mesenchymal cells alone, one to one with a volume of 1 ml in the lesion area in the skin and hair research center. The duration of the treatment is 4 sessions with an interval of 1 month. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: Six months after the publication and printing of the article To whom: Academic researchers and experts Conditions: In order to analyze the results of the study outcomes Where to obtain: etaghiabadi@sina.tums.ac.ir Address of the workplace: No. 4, 4th floor, Ban Best Maryam, South Kamraniya, Tehran Postal code:19737957511 Phone number:+982126657541 Mobile:+989128057398 How to obtain: It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 3 months. Comments:
public Ehsan Taghiabadi
No.4, 4th floor, Maryam dead end. South Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Ehsan Taghiabadi
No.4, 4th floor, Maryam dead end, South Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 ethaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 50 years Full satisfaction of the participant in the plan Has melasma (with all three degrees of mild, moderate, severe) 18 years 50 years Female Previous treatment of melasma Pregnancy and Breastfeeding Active skin infection Use of drugs that can affect bleeding or clotting mechanism Immunosuppression Use of local and systemic steroids Disease systemic diseases (such as high blood pressure ,Diabetes ,heart, kidney and liver diseases) The use of exfoliators 4 weeks before treatment In places where botulinum injection has been done, should not be done due to the possibility of microneedle toxin release. Participation in other clinical trials L81.4 Other melanin hyperpigmentation Treatment - Other Treatment - Other Treatment - Other Control group: CO2 laser is performed as a routine treatment for melasma disease, so group A patients are treated using CO2 laser with a wavelength of 30 j and for 5 minutes in the skin and stem cell center by a specialist doctor and the duration of treatment is 4 sessions with an interval of 1 month. Intervention group: Group B is treated by injecting the optimal amount of extracellular vesicles derived from Wharton jelly mesenchymal cells in one-to-one dimensions with a volume of 1 ml in the lesion area along with CO2 laser at the Skin and Hair Research Center. The duration of treatment is 4 sessions with an interval of 1 month. Intervention group: Group C is treated by injecting the optimal amount of extracellular vesicles derived from Wharton's jelly mesenchymal cells alone, one to one with a volume of 1 ml in the lesion area in the skin and hair research center. The duration of the treatment is 4 sessions with an interval of 1 month. The amount of melanin in the skin. Timepoint: Before starting the treatment and two months after the end of the treatment period (four months after the start of the treatment), biometric examination will be done. Method of measurement: Biometric device 9MPA-. Examination of skin spots and skin color. Timepoint: Before starting the treatment and two months after the end of the treatment period (four months after the start of the treatment), biometric examination will be done. Method of measurement: Visoface biometric device. Recovery rate. Timepoint: before the start of treatment and two months after the end of the treatment period (four months after the start of treatment). Method of measurement: Photography with ImageJ software. Judgment and satisfaction of patients. Timepoint: before the start of treatment and two months after the end of the treatment period (four months after the start of treatment). Method of measurement: Observation of photographs by two doctors and questionnaire. Tehran University of Medical Sciences Approved 2023-12-26 Expert Committee on Ethics in Biomedical Research of Tehran University of Medical Sciences Deputy Research and Technology Office, 6th Floor , Central Organization of Tehran Universit of Medical Sciences Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)