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IRCT20080901001159N33 IRCT 2021-06-01 Tehran University of Medical Sciences Evaluation the effect of conditioned media of adipose drived stem cells on acne scar Comparison of the effectiveness of adipose-derived stem cell condition medium (ADSC_CM) combined with microneedling or fractional carbon dioxide laser on acne scar healing 2021-06-22 anticipated 30 Complete https://irct.ir/trial/31364 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, block randomization is used. Each patient was considered as a block and left and right sides of their face were randomly assigned to two groups using cards with study groups written on them, Blinding description: In each group, both sides of the face will be treated with CO2 laser or microneedling at the patient's scar area, immediately on one side of the face, the conditioned media of adipose derived stem cells and the other side of the face saline solution is used topically on the scar. 1 atrophic scar. Intervention 1: Intervention group: One side of the face after being anesthetized, is first treated with Fractional Laser Co2, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks. Intervention 2: Intervention group: One side of the face after being anesthetized, is first treated with microneedling, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks. Intervention 3: Control group: (Other side of face) After sufficient anesthesia, first treatment with Fractional Laser Co2, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks.:. Intervention 4: Control group: (Other side of face) After sufficient anesthesia, first treatment with microneedling, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Maryam Nouri
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2223 9387 m.nouri3023@gmail.com Skin and Stem cell Research Center of Tehran University of Medical Sciences scientific Mohammad Ali Nilforoushzadeh
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 901 588 6740 +98 21 2223 9387 nilforoosh@sina.tums.ac.ir Skin and Stem cell Research Center of Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 20-60 Having middle to severe atrophic scar in face region 20 years 60 years Both Pregnancy and breastfeeding History of cancer Pregnancy, breastfeeding Patients with active acne Vascular / muscle collagenous disorders of immunodeficiency or use of immunosuppressive drugs People with herpes disease are active People with Mental Disorders Active infection in the face L90.5 Scar conditions and fibrosis of skin Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: One side of the face after being anesthetized, is first treated with Fractional Laser Co2, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks. Intervention group: One side of the face after being anesthetized, is first treated with microneedling, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks. Control group: (Other side of face) After sufficient anesthesia, first treatment with Fractional Laser Co2, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks.: Control group: (Other side of face) After sufficient anesthesia, first treatment with microneedling, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks. Scar size. Timepoint: before and 3month after the intervention. Method of measurement: visioface. Side effects. Timepoint: One week after session. Method of measurement: Questionnaire and visit. Patient Satisfaction. Timepoint: Three and six months after the last treatment session. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2021-02-14 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)