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IRCT20210130050181N1 IRCT 2021-02-13 Esfahan University of Medical Sciences Plasma-rich platelet veruss carboxytherapy for the treatment of periocular hyperpigmentation PRP: Plasma rich platelet Plasma-rich platelet veruss carboxytherapy for the treatment of periocular hyperpigmentation; which approach is superior? 2021-02-08 anticipated 20 Complete https://irct.ir/trial/54015 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The two dermatologists who interpreted the photographs were blinded to the type of approach used for each side of the face. Besides, in order to prevent bias, they were unaware that a photograph was taken preoperatively or postoperatively. N/A Periocular hyperpigmentation. Intervention 1: Intervention group: Carboxytherapy was performed by injection of carbon dioxide gas once weekly for six weeks. The amount of 5cc of CO2 was intradermally injected at the one-third lateral part of each eyelid using a 30-gauge needle with a velocity of 50 cc per minute. Intervention 2: Intervention group: The other side of the face was treated using one cc of PRP injected in periorbital space using an insulin syringe every two weeks for three times. The injections were performed intradermally in the space lying within a centimeter under lower eyelid and amount of 0.2-0.3 cc in 1.5-2 mm depth in each point of injection. The sites of injections were 1 centimeter apparent to the other ones. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to security of patient secret
public Akram Sadat Amiri
Alzahra Hospital, Soffe Ave.
Isfahan Iran (Islamic Republic of) 8174676431 +98 31 3653 3805 sadstamiri1367@Gmail.com Esfahan University of Medical Sciences scientific Fateme Mokhtari
Al Zahra hospital, Hakim Nezami Ave.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3653 3805 f_mokhtari2004@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 3-4 Fitzpatrick skin type Age 20-65 years old 20 years 65 years Both History of internal medical diseases(e.g., no previous history of cardiac, liver and/or renal diseases, diabetes mellitus, and thyroid dysfunction History of platelet disorders and/or coagulopathy Smoking and/or addiction Lactating or pregnancy Patients' unwillingness of participation in the study Use of other therapeutic approaches Treatment - Other Treatment - Other Intervention group: Carboxytherapy was performed by injection of carbon dioxide gas once weekly for six weeks. The amount of 5cc of CO2 was intradermally injected at the one-third lateral part of each eyelid using a 30-gauge needle with a velocity of 50 cc per minute. Intervention group: The other side of the face was treated using one cc of PRP injected in periorbital space using an insulin syringe every two weeks for three times. The injections were performed intradermally in the space lying within a centimeter under lower eyelid and amount of 0.2-0.3 cc in 1.5-2 mm depth in each point of injection. The sites of injections were 1 centimeter apparent to the other ones. Score of periocular hyperpigmentation. Timepoint: Before and within eight weeks after study performance. Method of measurement: Visual analog scale score. Esfahan University of Medical Sciences Approved 2019-03-05 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjerib Ave. Isfahan Isfehan Iran (Islamic Republic of)