]>
IRCT20200623047891N2 IRCT 2022-08-21 Kerman University of Medical Sciences Assessing effectiveness of PRP and tranexamic acid + vitamne C mesotherapy in the treatment of periorbital dark circle Comparision of the effectiveness of platelet-rich plasma (PRP) and tranexamic acid + vitamne C mesotherapy in the treatment of periorbital hyperpigmentation (POH) 2021-11-22 anticipated 20 Complete https://irct.ir/trial/58411 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 20 participants will participate in this trial. because there is right and left side fore the face of each participant, there is 40 areas for treatment. we allocate the letter R to the right side of each participant and the letter L to the left side. Then we organize the letters R & L from number 1 t0 40 (i.e RLRLRL...RL). One row and one column will be randomly chosen from the table of random numbers; the intersection between this row and column will be the starting point for sampling. A finger will be put on the starting point and will be moved downwards through the table. Because there should be 20 areas in the intervention group A (tranexamic acid & vitamin C) and 20 areas in the control group B (PRP) , the two digits at the right side of each number in the table will be considered. The moving of finger will be repeated until 20 areas of the intervention group A will be chosen. Duplicate numbers and numbers larger than 40 will not be considered. In this way, it will be found out that which 20 numbers among all of the 40 numbers given to the whole areas will be allocated to the intervention group A (e.g. numbers 3, 4, 9, 11, 13, 14, ...). The remaining 20 areas will be automatically put in the control group B, Blinding description: This is a double-blind study. Blinding was done in two levels: The first level: the dermatologist examining the effectiveness rate on each side of the treated face, who was different from the main dermatologist directing the study, and was not aware of the type of treatment performed on each side of the face. second level: data analyzer, who was not given information about the type of treatment performed on each side of the face and their possible effectiveness. 2-3 Periorbital hyperpigmentation. Intervention 1: Intervention group: Intra dermal injection of 0.5cc tranexamic acid and 0.5cc vitamin C into the infraorbital region in 3 session with 3-week intervals.(at the beginning of the study, general explanations about how to perform the work and after care were provided to all volunteer patients participating in the study. 0.5cc of 5cc ampoules of tranexamic acid from Caspian Tamin Iran Company along with 0.5cc of a 5cc ampoule of Vitamin C from Elixir Company was mixed in a 1cc BD syringe and injected intradermally into the dark areas around the eyes at an angle of 15-30 degrees (the desired points at a distance of 0.5-1cm) considered and 0.1cc was injected at each point).This treatment was done for three sessions, with an interval of three weeks. Intervention 2: Control group: Intra dermal injection of 1cc platelet rich plasma into the infraorbital region in 3 session with 3-week intervals. (At first, general explanations about how to perform the work and after care were given to all volunteer patients participating in the study. 5 cc of blood was taken from each patient. Then the sample was centrifuged at 1500 revolutions per minute for ten minutes. It was centrifuged. The clear plasma placed on the surface was separated and 1 cc of it was transferred to a 1 cc BD syringe. The injection was done at an angle of 15-30 degrees, intradermally to the dark areas around the eyes. (The desired points were considered with a distance of 0.5-1cm and 0.1cc was injected at each point). This treatment was done for three sessions, three weeks apart.). 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 more information.
public Behzad Iranmanesh
Afzalipour hospital, Imam highway, Kerman
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3132 8328 behzad_ariiana@yahoo.com Kerman University of Medical Sciences scientific Behzad Iranmanesh
Afzalipour hospital, Imam highway, Kerman
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3132 8328 behzad_ariiana@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Diagnosis of non-structural POH by dermatologist in Afzalipour hospital dermatology clinic Filling the written letter of satisfaction to participate in the project Minimum age of 18 when filling the letter of satisfaction Male or non-pregnant, non-breast feeding female gender 18 years 65 years Both Smoking Previous or current bleeding disorders Using anti coagulant medications Presence of any active lesion in the treatment area L81.4 Other melanin hyperpigmentation Treatment - Drugs Treatment - Drugs Intervention group: Intra dermal injection of 0.5cc tranexamic acid and 0.5cc vitamin C into the infraorbital region in 3 session with 3-week intervals.(at the beginning of the study, general explanations about how to perform the work and after care were provided to all volunteer patients participating in the study. 0.5cc of 5cc ampoules of tranexamic acid from Caspian Tamin Iran Company along with 0.5cc of a 5cc ampoule of Vitamin C from Elixir Company was mixed in a 1cc BD syringe and injected intradermally into the dark areas around the eyes at an angle of 15-30 degrees (the desired points at a distance of 0.5-1cm) considered and 0.1cc was injected at each point).This treatment was done for three sessions, with an interval of three weeks. Control group: Intra dermal injection of 1cc platelet rich plasma into the infraorbital region in 3 session with 3-week intervals. (At first, general explanations about how to perform the work and after care were given to all volunteer patients participating in the study. 5 cc of blood was taken from each patient. Then the sample was centrifuged at 1500 revolutions per minute for ten minutes. It was centrifuged. The clear plasma placed on the surface was separated and 1 cc of it was transferred to a 1 cc BD syringe. The injection was done at an angle of 15-30 degrees, intradermally to the dark areas around the eyes. (The desired points were considered with a distance of 0.5-1cm and 0.1cc was injected at each point). This treatment was done for three sessions, three weeks apart.) Severity of periorbital hyperpigmentation. Timepoint: At the begining of the study (before intervention) and 1 and 3 months after intervention. Method of measurement: Using Patient and Physician Global Assessment score. Kerman University of Medical Sciences Approved 2020-11-08 Ethics committee of Kerman University of Medical Sciences Ebne Sina Ave, Tahmasb Abad Blvd Kerman Kerman Iran (Islamic Republic of)