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IRCT20220322054341N2 IRCT 2023-01-20 Skin and Stem Cell Research Center of Tehran University of Medical Sciences The effect of erbium laser in striae Comparison of the therapeutic effect of the combination of Erbium YAG laser and stromal vascular fraction (SVF), the combination of Erbium YAG laser and platelet-rich plasma (PRP) and Erbium YAG laser alone in the treatment of striae 2023-01-14 anticipated 10 Complete https://irct.ir/trial/67854 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After being selected by available method, lesions are divided into 3 groups by simple randomization, so that among 30 sealed bags, one bag will be randomly selected for each lesion. Each bag contains the letter a, b, or c, Blinding description: The injection of stromal vascular fraction (SVF), platelet-rich plasma (PRP) and normal saline was done with syringes of the same shape, the contents of which are not known, and the patient does not know which treatment group he is in. Also, the doctor evaluating the results and the statistician are blinded to the treatment group of the patient. 2-3 striae distensae. Intervention 1: Intervention group 1: combination of erbium Yag laser and intralesional injection of stromal vascular fraction (SVF). Erbium YAG laser usually selectively targets hydrous tissue with light of 2940 nm wavelength, and the residual thermal damage in the dermis leads to the accumulation and regeneration of collagen. SVF preparation: Mesenchymal stem cells are obtained by aspirating 20 to 40 cc of fat from the human thigh or abdomen during a surgical procedure (3 cm incision). The lipoaspirate is first washed thoroughly in phosphate-buffered saline before undergoing enzymatic digestion with collagenase to obtain a single cell suspension. After digestion, the centrifuged cell pellet (referred to as the Stromal Vascular Fraction (SVF)) is resuspended in StemMACS™ MSC Expansion Media before being serially filtered through 100-µm and then 40-µm nylon filters and the mononuclear cell fraction The cell sample is counted and cultured in StemMACS MSC Expansion Media. MSCs will adhere to plastic surfaces within 24 hours, after which the media should be replaced with fresh StemMACS MSC Expansion Media. 2-3 cc of the prepared solution SVF are injected subcutaneously at one centimeter intervals using a 1cc syringe. Intervention 2: Intervention group 2: combination of erbium Yag laser followed by intralesional injection of platelet-rich plasma (PRP). Platelet-rich plasma: First, the anticoagulant drug is added with a 20-ml syringe at a ratio of 1 to 10 (one milliliter of anticoagulant per ten milliliters of the patient's blood sample). A 50-ml blood sample is then drawn from the patient's internal cubital vein. Time is given for 10 seconds to ensure that the blood sample mixes with the anticoagulant drug. The tubes containing the above substance are centrifuged at 3000 rpm for 4 minutes. After centrifugation, there are three parts in the tube: a plasma part with few platelets, a tissue part and a red blood cell part. Since PRP is a combination of tissue and plasma, the red blood cells are separated from the kits. For final concentration, the separate parts containing PPP and buffy coat are centrifuged again at 3000 rpm for 4 minutes. The remaining PRP is then aspirated from each test tube and activated by adding calcium chloride (0.1 ml per 0.9 ml PRP) to finally obtain 6 ml of active PRP. Intervention 3: Intervention group 3: Combination of erbium Yag laser followed by intralesional injection of Normal Saline. 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 There is no further information
public Masoumeh Roohaninasab
Rasule akram hospital, niyayesh ave, sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2421 rohaninasab.m@iums.ac.ir Iran University of Medical Sciences scientific Masoomeh Roohaninasab
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 masoomehrohani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) The diagnosis of stria distensa based on the diagnosis of a dermatologist Age less than 50 years and more than 18 years 18 years 50 years Both Using any treatment method to remove striae in the last three months Presence of lesions and skin diseases such as skin cancer or infections Presence of collagen vascular diseases Pregnancy and lactation Using steroids or immunosuppressive drugs L90.6 Striae atrophicae Treatment - Other Treatment - Other Treatment - Other Intervention group 1: combination of erbium Yag laser and intralesional injection of stromal vascular fraction (SVF). Erbium YAG laser usually selectively targets hydrous tissue with light of 2940 nm wavelength, and the residual thermal damage in the dermis leads to the accumulation and regeneration of collagen. SVF preparation: Mesenchymal stem cells are obtained by aspirating 20 to 40 cc of fat from the human thigh or abdomen during a surgical procedure (3 cm incision). The lipoaspirate is first washed thoroughly in phosphate-buffered saline before undergoing enzymatic digestion with collagenase to obtain a single cell suspension. After digestion, the centrifuged cell pellet (referred to as the Stromal Vascular Fraction (SVF)) is resuspended in StemMACS™ MSC Expansion Media before being serially filtered through 100-µm and then 40-µm nylon filters and the mononuclear cell fraction The cell sample is counted and cultured in StemMACS MSC Expansion Media. MSCs will adhere to plastic surfaces within 24 hours, after which the media should be replaced with fresh StemMACS MSC Expansion Media. 2-3 cc of the prepared solution SVF are injected subcutaneously at one centimeter intervals using a 1cc syringe. Intervention group 2: combination of erbium Yag laser followed by intralesional injection of platelet-rich plasma (PRP). Platelet-rich plasma: First, the anticoagulant drug is added with a 20-ml syringe at a ratio of 1 to 10 (one milliliter of anticoagulant per ten milliliters of the patient's blood sample). A 50-ml blood sample is then drawn from the patient's internal cubital vein. Time is given for 10 seconds to ensure that the blood sample mixes with the anticoagulant drug. The tubes containing the above substance are centrifuged at 3000 rpm for 4 minutes. After centrifugation, there are three parts in the tube: a plasma part with few platelets, a tissue part and a red blood cell part. Since PRP is a combination of tissue and plasma, the red blood cells are separated from the kits. For final concentration, the separate parts containing PPP and buffy coat are centrifuged again at 3000 rpm for 4 minutes. The remaining PRP is then aspirated from each test tube and activated by adding calcium chloride (0.1 ml per 0.9 ml PRP) to finally obtain 6 ml of active PRP. Intervention group 3: Combination of erbium Yag laser followed by intralesional injection of Normal Saline. Pigmentation (color of the lesion). Timepoint: 3 months after the treatment. Method of measurement: Biometry with Colorimeter 4000, Multi Probe Adaptor System 5 (MPA5). Elasticity of the skin. Timepoint: 3 months after the treatment. Method of measurement: Biometry with Cutometer, Multi Probe Adaptor System 580 (MPA580). Patient satisfaction. Timepoint: 3 months after the treatment. Method of measurement: Based on patient global assessment score. Complications. Timepoint: 3 months after the treatment. Method of measurement: Using a checklist containing treatment complications including pain, erythema and edema. Skin and Stem Cell Research Center of Tehran University of Medical Sciences Approved 2023-01-17 Research Ethics Committee of School of Medicine, Iran University of medical sciences School of medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)