]>
IRCT20220808055641N3 IRCT 2023-01-07 Tehran University of Medical Sciences Comparing the effectiveness of stem cell conditioned medium and platelet-rich plasma injection in combination with noncross-linked hyaluronic acid in the treatment of atrophic acne scars. A comparative study of the efficacy of Wharton jelly mesenchymal stem cell conditioned medium injection combined with hyaluronic acid and platelet rich plasma injection combined with hyaluronic acid in the treatment of atrophic acne scars in patients treated with CO2 fractional laser: a double-blind clinical trial 2023-01-20 anticipated 20 Complete https://irct.ir/trial/67689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: The studied subjects are divided into two groups of ten people named a and b by simple randomization. The method of randomization is as follows: when people enter the study, out of twenty envelopes whose contents are completely invisible and ten of them contain the letter a and ten contain the letter b, they choose one envelope. and are placed in group a or b. Also, all people in group a choose one envelope from the other 2 envelopes that contain the letters R and L, and each patient chooses the envelope containing the letter L to inject mesenchymal stem cell conditioned medium in The combination with non-cross-linked hyaluronic acid will be performed on the acne scar on the left side of the face, and each patient will be injected on the right side by selecting the envelope containing the letter R. Also, all the people of group b chose one envelope from the two envelopes containing the letters R and L. If the letter L is inserted, prp injection in combination with non-cross-linked hyaluronic acid on the left side of the face, and if the letter R is inserted, the above injection. It will be done on the right side of the face. Obviously, in both groups a and b, non-cross-linked hyaluronic acid will be injected alone on the opposite side. In group A, all patients were injected with mesenchymal stem cell conditioned medium in one half of the face in combination with noncross linked hyaluronic acid, and in the opposite half, noncross linked hyaluronic acid was injected alone. In group B, all patients were injected with PRP in combination with noncross linked hyaluronic acid in one half of the face, and noncross linked hyaluronic acid was injected alone in the opposite half, 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: In group A, all patients in one half of the face received 2 cc mesenchymal stem cell conditioned medium from Wharton jelly in combination with 2 cc injection of noncross linked hyaluronic acid, which is available in 5 cc vials under the name of cocktail 532 of Revitacare company. and two 1 cc syringes are injected for each patient. In all patients, a re-injection is performed after 2 months. Intervention 2: Intervention group: In group a, all patients in the opposite half of the face are injected with noncross linked hyaluronic acid, which is available in the form of 5 cc vials under the name of cocktail 532 of Revitacare company, and two 1 cc syringes are injected for each patient. In all patients, a re-injection is performed after 2 months. Intervention 3: 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. , together with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 2 1 cc syringes prepared from 5 cc vials of Revitacare Company's cocktail 532, it is injected at the site of acne scars on one half of the face in group a. 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: In group b, all patients in the opposite half of the face are injected with noncross linked hyaluronic acid, which is available in the form of 5 cc vials under the name of cocktail 532 of Revitacare company, and two 1 cc syringes are injected for each patient. In all patients, a re-injection is performed after 2 months. 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 65 years Both Age less than 18 years or more than 65 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: In group A, all patients in one half of the face received 2 cc mesenchymal stem cell conditioned medium from Wharton jelly in combination with 2 cc injection of noncross linked hyaluronic acid, which is available in 5 cc vials under the name of cocktail 532 of Revitacare company. and two 1 cc syringes are injected for each patient. In all patients, a re-injection is performed after 2 months. Intervention group: In group a, all patients in the opposite half of the face are injected with noncross linked hyaluronic acid, which is available in the form of 5 cc vials under the name of cocktail 532 of Revitacare company, and two 1 cc syringes are injected for each patient. In all patients, a re-injection is performed after 2 months. 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. , together with the injection of 2 cc of non-cross-linked hyaluronic acid in the form of 2 1 cc syringes prepared from 5 cc vials of Revitacare Company's cocktail 532, it is injected at the site of acne scars on one half of the face in group a. 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: In group b, all patients in the opposite half of the face are injected with noncross linked hyaluronic acid, which is available in the form of 5 cc vials under the name of cocktail 532 of Revitacare company, and two 1 cc syringes are injected for each patient. In all patients, a re-injection is performed after 2 months. 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 2022-12-22 کمیته اخلاق دانشگاه علوم پزشکی تهران No 6, Avesta Ave, Azadi Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)