]>
IRCT20211108052997N1 IRCT 2021-12-18 Iran University of Medical Sciences Evaluation of the effect of microneedling and phenytoin cream on atrophic scars compared to microneedling Evaluation of efficacy and safety of microneedling and phenytoin cream 1% compared to microneedling in atrophic scars caused by facial acne: a double-blind randomized clinical trial 2021-12-31 anticipated 25 Complete https://irct.ir/trial/60028 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is random among patients referred to Hazrat Rasool Akram Hospital. The randomization method is simple. Our tool is to randomize the table of random numbers and place them inside sealed bags. Each bag contains the letters A or B: A: for the group receiving microneedling and phenytoin cream on the right and only microneedling on the left side of the face. B: for the group receiving microneedling and phenytoin cream on the left and only microneedling on the right side of the face, Blinding description: The patient and 2 evaluating dermatologists will be blinde to which side of the face received microneedling and phenytoin. Also, they will not know which side of the face is the only microneedling done. 3 Atrophic Scars. Intervention 1: Intervention group: The intervention group is patients suffering from Atrophic scar lesion. The intervention group will be treated with microneedling and 1% Phenytoin topical cream, made by Medifarm company, three times a day for a week. The number of microneedling sessions will be monthly for three months (with an interval of one month and three times). Nysoya machine and 36 needle cartridges will be used for microneedling. The speed of the microneedling device will be set at 100 Hz and the penetration depth of the needles will initially be half a millimeter.Then the depth of penetration of the needles will gradually increase until there is a bleeding pinpoint on the skin. The handpiece will be done perpendicular to the skin as well as horizontally and rotationally, and spot bleeding during microneedling will be cleared with normal sterile saline. Local anesthesia using Xylopi topical cream will be performed one hour before the intervention on patients. After the intervention, the face will be washed with normal saline. Intervention 2: Control group: All steps performed for the intervention group will be repeated for the control group, except that the control group will be treated wit microneedling and Mupirocin cream only three times a day as a placebo for one week. It should be noted that each patient is considered both control group and intervention group. One side of the patient's face will be the control group and the opposite side will be the intervention group. 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 Dr. Afsaneh Sadeghzadeh Bazarghan
Dermatology ward, Hazrat Rasool Akram hospital,Niayesh avenue,Sattarkhan street,Tehran,Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 Sadeghzadeh.a@iums.ac.ir Iran University of Medical Sciences scientific Dr.Afsane Sadeghzadeh Bazarghan
Hazrat Rasool Akram, Niyayesh Ave, Sattarkhan street,Tehran.Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 Sadeghzadeh.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with atrophic facial acne scars aged 18-45 years Patients with skin type 1-4 18 years 45 years Both Sensitivity to phenytoin. Patients who have received laser treatment in the last three months. Patients with active colloidal scar or active skin lesion at the injection site. History of malignancy or receiving chemotherapy. L91.0 Hypertrophic scar Treatment - Other Treatment - Other Intervention group: The intervention group is patients suffering from Atrophic scar lesion. The intervention group will be treated with microneedling and 1% Phenytoin topical cream, made by Medifarm company, three times a day for a week. The number of microneedling sessions will be monthly for three months (with an interval of one month and three times). Nysoya machine and 36 needle cartridges will be used for microneedling. The speed of the microneedling device will be set at 100 Hz and the penetration depth of the needles will initially be half a millimeter.Then the depth of penetration of the needles will gradually increase until there is a bleeding pinpoint on the skin. The handpiece will be done perpendicular to the skin as well as horizontally and rotationally, and spot bleeding during microneedling will be cleared with normal sterile saline. Local anesthesia using Xylopi topical cream will be performed one hour before the intervention on patients. After the intervention, the face will be washed with normal saline. Control group: All steps performed for the intervention group will be repeated for the control group, except that the control group will be treated wit microneedling and Mupirocin cream only three times a day as a placebo for one week. It should be noted that each patient is considered both control group and intervention group. One side of the patient's face will be the control group and the opposite side will be the intervention group. Qualitative intensity of atrophic scar. Timepoint: 1-At the beginning of the study, 2- before the second turn 3- before the third turn. 4. Two months after the end of the treatment period. Method of measurement: Photography by visioface. Objective observation.Visioface a full face photographic method for facial skin analysis. It has an accurate software to take high resolution full face photos and allows faster image capture with automatic skin type classification. By processing these images, skin problems are identified. Quantative intensity of atrophic scars. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Determine the depth of the scar by shooting by visioface,Scoring with Baron and Goodman scale. Adverse events. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Patient report, physician diagnosis. The rate of improvement of scar. Timepoint: 1) At the beginning of the study. 2) Before the second turn 3) Before the third turn. 4) Two months after the end of the treatment period. Method of measurement: Patient satisfaction, photography by visioface, physician diagnosis. Iran University of Medical Sciences Approved 2021-08-17 Ethics Committee of Iran University of Medical Sciences Hazrat Rasool Akram hospital, Mansoori avenue,sattarkhan street,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)