]>
IRCT20160820029436N3 IRCT 2018-02-04 Deputy of Research, Shahid Beheshti University of Medical Sciences Efficacy and saftey of fractional Er:YAG versus microneedling in treatment of facial rhytides Efficacy and saftey of fractional Er:YAG versus microneedling in treatment of facial rhytides in 45-75 years old patients 2018-01-05 anticipated 36 Complete https://irct.ir/trial/23660 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Controlled Split-Face Clinical Trial, Randomization description: In individuals entered into the study, one half of the face is randomly studied by laser and the other half by micronidling, Blinding description: In individuals entered into the study, one half of the face is randomly studied by laser and the other half by micronidlikg, Patients are unaware of the nature of the action taken on each side of the face. Assessment practitioners are also unaware of the action taken, for example, they do not know in Patient A that they are on the right side of the laser or micronizing. N/A Facial skin wrinkles. Intervention 1: In 45 to 75 years old patients with mild to moderate facial skin wrinkles, a half-face is subjected to a microneedling monthly up to three time and Its efficacy and safety are examined by the methods described in the study method. Intervention 2: Control group: In 45 to 75 years old patients with mild to moderate facial skin wrinkles, a half-face is subjected to a Fractional ER:YAG laser (the ER:YAG laser with a 7-micron spot, a 350 microsecond pulse and a total fluence of 3.12 J per cm 2 and an energy pulse of 1 to 1.2 J with a fractional handpiece) monthly up to three time and Its efficacy and safety are examined by the methods described in the study method. Yes - There is a plan to make this available What will be shared: Adaptation of information recorded by the reviscometer and the clinical response along the photos of the camera, and the degree of satisfaction of the participants with the procedures performed in different patients according to skin phenotype and the response to each of the two methods listed in the study, published in the separate table When: After completing the treatment and patients' fallow up To whom: Researchers of academic institutions Conditions: All dermatologists can access the data to use procedure for their patients. Where to obtain: Refer to the Dermatology Research Center at Shohada e Tajrish Hospital in Tehran. Accountability will be done by Dr. Behnaz Hamedani How to obtain: The request is submitted in writing. Comments:
public Behnaz Hamedani
Shohada'e Tajrish Hospital, Tajrish Square
Tehran Iran (Islamic Republic of) 4571935935 +98 24 3552 5289 hamedanibehnaz@gmail.com Skin Research Center of Shahid Beheshti University scientific Reza Robati
Shohada'e Tajrish Hospital, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1508 rezarobati@sbmu.ac.ir Skin Research Center of Shahid Beheshti Uneversity Iran (Islamic Republic of) Age 45 to 75 Mild to moderate wrinkling on the face 45 years 75 years Both Pregnant or breast feed History of cuagulopathy disorder or drug Facial active Infection Inability to fallow up visit connective tissue disorder History of skin cancer on face Unrealistic expectation Cosmetic procedures performed on the face in the last 6 month Fitzpatrick skin phototype >III Sensitivity to lidocain Use isotretinoin in the last 6 month History of keloid Use photosensitive drug such gold, tetracyclin Treatment - Devices Treatment - Devices In 45 to 75 years old patients with mild to moderate facial skin wrinkles, a half-face is subjected to a microneedling monthly up to three time and Its efficacy and safety are examined by the methods described in the study method. Control group: In 45 to 75 years old patients with mild to moderate facial skin wrinkles, a half-face is subjected to a Fractional ER:YAG laser (the ER:YAG laser with a 7-micron spot, a 350 microsecond pulse and a total fluence of 3.12 J per cm 2 and an energy pulse of 1 to 1.2 J with a fractional handpiece) monthly up to three time and Its efficacy and safety are examined by the methods described in the study method. Transepidermal water loss. Timepoint: Before each treatment session and then after three month of treatment. Method of measurement: Measurement of skin biophysical properties by MPA-9 device. Skin hydration. Timepoint: Before each treatment session and then after three month of treatment. Method of measurement: By dermatologist and using MPA-9 device. Patient satisfaction. Timepoint: Before each treatment session monthly and then after three month of treatment. Method of measurement: Asking the patient. Downtime. Timepoint: Before tretment every month and then after three month of treatment. Method of measurement: By dermatologist. Clinical assessment of improvement. Timepoint: Before treatment every month and then after three month of treatment. Method of measurement: By dermatologist by comparing the patient's pictures. Skin resonance time. Timepoint: Before treatment every month and then after three month of treatment. Method of measurement: By dermatologist and using reviscometer. Pain. Timepoint: Before esch treatment session monthly. Method of measurement: Asking the patient. Burning. Timepoint: Before esch treatment session. Method of measurement: Asking the patient. Erythema. Timepoint: Before esch treatment session. Method of measurement: Asking the patient. Edema. Timepoint: Before esch treatment session. Method of measurement: Asking the patient. Bulla formation. Timepoint: Before esch treatment session. Method of measurement: Asking the patient. Bleeding. Timepoint: Before esch treatment session. Method of measurement: Asking the patient. Dispigmentation. Timepoint: Before esch treatment session. Method of measurement: Asking the patient and by dermatologist. Scar formation. Timepoint: Before esch treatment session. Method of measurement: Asking the patient and by dermatologist. Skin atrophia. Timepoint: Before esch treatment session. Method of measurement: Asking the patient and by dermatologist. Crust formation. Timepoint: Before esch treatment session. Method of measurement: Asking the patient and by dermatologist. Deputy of Research, Shahid Beheshti University of Medical Sciences Approved 2016-10-23 Ethics committee of Skin Research Center, Shahid Beheshti University of Medical Sciences Shohada'e Tajrish Hospital, Tajrish Square, Tehran Tehran Tehran Iran (Islamic Republic of)