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IRCT20200127046282N28 IRCT 2023-05-06 Tehran University of Medical Sciences Evaluation of safety and effectiveness of liposomal hyaluronic acid, PRP and vitamin C in rejuvenation and brightening under the eyes Evaluation of safety and effectiveness of liposomal hyaluronic acid, PRP and vitamin C in rejuvenation and brightening under the eyes 2023-05-10 anticipated 90 Complete https://irct.ir/trial/66793 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The data evaluator is given a general explanation of the study, but one method is not presented as superior to another, and no preference is given to one of the interventions. As a result, this person is blind to the effect of the intervention. The patient and the doctor will not be blinded and will know about the study groups. 1-2 Darkening under the eye. Intervention 1: Intervention group: Patients use 1 cc liposomal hyaluronic acid (Zist Sakht Bonyan Pars Company) products topically in the area under the eyes once a day for three months. Intervention 2: Control group: Patients receive 1 cc hyaluronic acid products (Zist Sakht Bonyan Pars Company) locally in the clinic three times with an interval of one month after performing microneedling. Intervention 3: Intervention group: Patients use 1 cc liposomal platelet-rich plasma (Zist Sakht Bonyan Pars Company)products topically in the under-eye area once a day for three months. Intervention 4: Control group: Patients receive 1 cc platelet-rich plasma product (Zist Sakht Bonyan Pars Company) locally in the clinic three times with an interval of one month after microneedling. Intervention 5: Intervention group: Patients use 1 cc liposomal vitamin C (Zist Sakht Bonyan Pars Company) topically in the area under the eyes once a day for three months. Intervention 6: Control group: Patients receive 1 cc vitamin C product (Zist Sakht Bonyan Pars Company) topically in the area under the eyes three times with an interval of one month after performing microneedling. Intervention 7: Control group: Patients use the 1 cc non- liposomal hyaluronic acid (Zist Sakht Bonyan Pars Company) product topically in the area under the eyes once a day for three months. Intervention 8: Control group: Patients use 1 cc non- liposomal platelet-rich plasma (Zist Sakht Bonyan Pars Company) product topically in the under-eye area once a day for three months. Intervention 9: Control group: Patients use 1 cc non- liposomal vitamin C (Zist Sakht Bonyan Pars Company) product topically in the area under the eyes once a day for three months. 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 -
public Sona Zare
No 4, Maryam Alley, South Kamraniyeh Street
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 sonazarebio@gmail.com Skin and Stem Cell Research Center, Tehran University of Medical Sciences scientific Mohammad Ali Nilforoushzadeh
No. 4, Maryam Alley, South Kamraniye St.
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 Dr_nilforoush@yahoo.com ُSkin and Stem Cell Research Center, Tehran University of Medical Sciences Iran (Islamic Republic of) Darkness and wrinkles in the lower eyelid area, which need to be treated according to the opinion of the hospital doctor and the patient's desire. 21 years 60 years Both Patients who had undergone previous surgery in the eyelid area Have had previous minimally invasive treatments such as botulinum toxin or fillers in the eyelid area. Patients with active skin disorders or inflammation, acute or chronic infection, tumors or cancer Patients under anticoagulant treatment smokers Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: Patients use 1 cc liposomal hyaluronic acid (Zist Sakht Bonyan Pars Company) products topically in the area under the eyes once a day for three months. Control group: Patients receive 1 cc hyaluronic acid products (Zist Sakht Bonyan Pars Company) locally in the clinic three times with an interval of one month after performing microneedling. Intervention group: Patients use 1 cc liposomal platelet-rich plasma (Zist Sakht Bonyan Pars Company)products topically in the under-eye area once a day for three months. Control group: Patients receive 1 cc platelet-rich plasma product (Zist Sakht Bonyan Pars Company) locally in the clinic three times with an interval of one month after microneedling. Intervention group: Patients use 1 cc liposomal vitamin C (Zist Sakht Bonyan Pars Company) topically in the area under the eyes once a day for three months. Control group: Patients receive 1 cc vitamin C product (Zist Sakht Bonyan Pars Company) topically in the area under the eyes three times with an interval of one month after performing microneedling. Control group: Patients use the 1 cc non- liposomal hyaluronic acid (Zist Sakht Bonyan Pars Company) product topically in the area under the eyes once a day for three months. Control group: Patients use 1 cc non- liposomal platelet-rich plasma (Zist Sakht Bonyan Pars Company) product topically in the under-eye area once a day for three months. Control group: Patients use 1 cc non- liposomal vitamin C (Zist Sakht Bonyan Pars Company) product topically in the area under the eyes once a day for three months. The amount of darkness under the eyes. Timepoint: prior to treatment, three and six months after the last treatment session. Method of measurement: VisioFace device. The amount of wrinkles under the eyes. Timepoint: prior to treatment, three and six months after the last treatment session. Method of measurement: Visioface. Patient satisfaction. Timepoint: prior to treatment, three months and six months after the last treatment session. Method of measurement: Standard questionnaires visual analogue scale (VAS). Tehran University of Medical Sciences Approved 2022-10-10 Research Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)