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IRCT20221130056672N2 IRCT 2023-11-25 Tehran University of Medical Sciences Effect of Local Injection of Umbilical Cord Blood Derived Serum versus Local Injection of Platelet Rich Plasma in the Treatment of Striae Distensae Evaluation of Effect of Local Injection of Umbilical Cord Blood Derived Serum versus Local Injection of Platelet Rich Plasma in the Treatment of Striae Distensae(A randomized controlled intervention study) 2023-12-22 anticipated 30 Complete https://irct.ir/trial/73549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 cord blood serum with a concentration of 2%, group B will be treated with cord blood serum with a concentration of 5% and group C patients will be treated with cord blood serum with a concentration of 10%, Blinding description: In this study,the participant researcher,doctor and evaluating doctor will be unaware of the type of treatment until the end of the study. 1-2 Striae Distensae. Intervention 1: Intervention group: Treated Local Injection of Umbilical Cord Blood Derived Serum. Intervention 2: Control group: Treated Local Injection of Platelet Rich Plasma. 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 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 2 to 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 striae alba (with all three degrees of mild, moderate, severe) 18 years 50 years Both Inflammatory acne Active herpes labialis Local infections in the treatment area Prone to keloid Malignancy Pregnancy Breastfeeding 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. Treatment - Other Treatment - Other Intervention group: Treated Local Injection of Umbilical Cord Blood Derived Serum Control group: Treated Local Injection of Platelet Rich Plasma Epidermis and dermis thickness. Timepoint: Before the start of the intervention and two months after the end of the treatment period (Four months after the start of the treatment). Method of measurement: Skin Scanner. The amount of collagen formation. Timepoint: Before the start of the intervention and two months after the end of the treatment period (Four months after the start of the treatment). Method of measurement: Visoface. Safety. Timepoint: At the beginning of the intervention, at each re-visit session and two months after the end of the treatment period (four months after the start of the treatment). Method of measurement: Patient history. Effectiveness. Timepoint: At the beginning of the intervention, at each re-visit session and two months after the end of the treatment period (four months after the start of the treatment). Method of measurement: Patient satisfaction. Tehran University of Medical Sciences Approved 2023-10-30 Ethics Committee 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)