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IRCT20220808055641N2 IRCT 2022-09-26 Tehran University of Medical Sciences Comparing the efficacy of platelet-rich plasma and non-cross-linked hyaluronic acid injection and their combination in the treatment of atrophic acne scars Comparison of the effectiveness of platelet-rich plasma injection with noncross-linked hyaluronic acid injection and platelet-rich plasma injection in combination with noncross linked hyaluronic acid in patients treated with fractional CO2 laser in the treatment of atrophic acne scars ; A double-blind clinical trial 2022-09-21 anticipated 10 Complete https://irct.ir/trial/65816 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: The studied subjects are divided into two groups of 5 a and b by simple randomization and individually, based on the random table of numbers. In group a, one half of the face is injected with platelet-rich plasma and in the opposite half of the face, platelet-rich plasma is injected with non-cross-linked hyaluronic acid. In group b, in one half of the face, non-cross-linked hyaluronic acid injection is performed, and in the opposite half, the combination of platelet-rich plasma and non-cross-linked hyaluronic acid is injected, Blinding description: The participants in the study, as well as the physician evaluating the clinical outcome, as well as the statistician analyzing the data, are kept blind to the type of injection performed at each location. N/A acne atrophic scar. Intervention 1: Intervention group: Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. And one time at the beginning of the study and another time, one month after the first time, is injected as an intradermal injection, in the place of acne scars of one half of the face in group a. Intervention 2: Intervention group:Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. , along with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 1 cc ready-to-injectable syringes of Juviderm company, which are two 1 cc syringes for each person intradermally, at the acne scar site of one half of the face Group a is injected. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention 3: Intervention group: Injection of non-cross-linked hyaluronic acid with a volume of 2 cc in the form of ready-to-injectable syringes of Juviderm company with a volume of 1 cc, two 1 cc syringes for each person intradermally, at the acne scar site of one half of the face in group b is injected. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention 4: Intervention group: Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. , along with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 1 cc ready-to-injectable syringes of Juviderm company, which are two 1 cc syringes for each person intradermally, at the acne scar site of one half of the face Group b is injected. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Yes - There is a plan to make this available What will be shared: After the completion of the study, all patient data will be shared through the article after de-identification. When: Access to data starts immediately after the publication of the article. To whom: There are no restrictions on people's access to data. Conditions: There is no restriction on the type of data usage. Where to obtain: rasool-E-akram hospital, niyayesh Ave, satar khan Blvd, Tehran alirezajafarzadeh8@gmail.com How to obtain: After receiving the email from the applicant, the data will be sent within a maximum of 6 months. Comments:
public Alireza Jafarzadeh
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
Tehran Iran (Islamic Republic of) 6567634523 +98 919 890 7445 Alirezajafarzadeh8@gmail.com Iran University of Medical Sciences scientific Alireza Jafarzadeh
No.6, ahmadzadeh ardabili Ave, Avesta Blvd, Azadi Blvd, Tehran Town
Tehran Iran (Islamic Republic of) 13244357653 +98 919 890 7445 Alirezajafarzadeh8@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Existence of atrophic acne scar treated with CO2 fractional laser 18 years 50 years Both Age less than 18 years or more than 50 years Atrophic scar created in the last 6 months Conducting therapeutic intervention for atrophic scar in the last one month except CO2 fractional laser Bleeding and coagulation disorder pregnancy breastfeeding L90 Atrophic disorders of skin Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. And one time at the beginning of the study and another time, one month after the first time, is injected as an intradermal injection, in the place of acne scars of one half of the face in group a. Intervention group:Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. , along with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 1 cc ready-to-injectable syringes of Juviderm company, which are two 1 cc syringes for each person intradermally, at the acne scar site of one half of the face Group a is injected. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention group: Injection of non-cross-linked hyaluronic acid with a volume of 2 cc in the form of ready-to-injectable syringes of Juviderm company with a volume of 1 cc, two 1 cc syringes for each person intradermally, at the acne scar site of one half of the face in group b is injected. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Intervention group: Injection of platelet-rich plasma in a volume of 2 cc, which is obtained after collecting whole blood from the study subjects, in the amount of 10 cc and centrifuging it at 5600 rpm, and contains plasma rich in platelet blood cells. , along with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 1 cc ready-to-injectable syringes of Juviderm company, which are two 1 cc syringes for each person intradermally, at the acne scar site of one half of the face Group b is injected. Each person is re-injected twice, one time at the beginning of the study and the second time, one month after the first time. Improvement of acne atrophic scar. Timepoint: The beginning of the study and 1 month after the start of the study and 3 months after the start of the study. Method of measurement: sonography;visioface;biometery;cutometery,physician global assessment score;patient global assessment score. Tehran University of Medical Sciences Approved 2022-08-13 Ethics committee of Tehran University of Medical Sciences No 6, Avesta Ave, Azadi Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)