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IRCT20190407043192N1 IRCT 2019-07-23 Shahid Beheshti University of Medical Sciences periorbital rejuvenation& palpebral laxity with plasma jet Efficacy and safety of plasma jet in periorbital rejuvenation & palpebral laxity 2018-12-11 anticipated 70 Complete https://irct.ir/trial/40265 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Periorbital rejuvenation. Intervention group: patients fulfilling the study inclusion criteria will be provided with all the information concerning the procedure and informing the research properties of the treatment. Patients will be asked to sign written consent. An expert dermatologist will evaluate all participants in this field before starting the study. After a local anesthetics cream (Lidocaine cream), the patient will be asked to wait for thirty minutes for the skin to be numbed. Before beginning thevtreatment, one must ensure that the skin surface is wiped clean of any local anesthetics cream. The plasma will be used first on the right eyelid and then left eyelid. These procedures will be repeated in three sessions in monthly intervals. Participants will be evaluated before treatment and one month and three months after the last treatment to evaluate the effectiveness of the treatment.. 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 Undecided - It is not yet known if there will be a plan to make this available
public Maryam Beheshti
Shohada-e Tajrish Hospital -Shahrdari St. Qods Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 ma_beheshti@yahoo.com Shahid Beheshti University of Medical Sciences scientific Fahimeh Abdollahimajd
Shohada-e Tajrish Hospital -Shahrdari St. Qods Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 fabdollahimajd@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People with chief complaint of palpebral laxity People with 35-65 years old 35 years 65 years Both Unwillingness to participate to the study History of skin infections such as herpes simplex History of neuromuscular or connective tissue diseases Uncontrolled diabetes melitus Immunosuppressant drugs Treatment - Devices Intervention group: patients fulfilling the study inclusion criteria will be provided with all the information concerning the procedure and informing the research properties of the treatment. Patients will be asked to sign written consent. An expert dermatologist will evaluate all participants in this field before starting the study. After a local anesthetics cream (Lidocaine cream), the patient will be asked to wait for thirty minutes for the skin to be numbed. Before beginning thevtreatment, one must ensure that the skin surface is wiped clean of any local anesthetics cream. The plasma will be used first on the right eyelid and then left eyelid. These procedures will be repeated in three sessions in monthly intervals. Participants will be evaluated before treatment and one month and three months after the last treatment to evaluate the effectiveness of the treatment. Evaluation of periorbital rejuvenation : no response (<10%), mild response (10-25%), moderate response (25-75%), excellent response (>75%). Timepoint: Before treatment ,one month after each treatment session , three months after the last treatment session. Method of measurement: Clinical images , Reviscometer device. Evaluation of the patient satisfaction. Timepoint: Before treatment, one month after each treatment session ,three months after the last treatment session. Method of measurement: Based on the patient response to the question (unsatisfactory , partial satisfaction , totally satisfied). Advers effects. Timepoint: Before treatment, one month after each treatment session ,three months after the last treatment session. Method of measurement: Based on the patient response to the question (infection , erythema , post inflammatory hyper or hypo pigmentation). Shahid Beheshti University of Medical Sciences Approved 2018-12-09 Ethics committee of ُSkin Research Center, Shahid Beheshti University of Medical Sciences Skin Research Center, Shohada-e Tajrish Hospital- Shahrdari St.-Qods Square Tehran Tehran Iran (Islamic Republic of)