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IRCT20181005041243N3 IRCT 2022-10-15 Tehran University of Medical Sciences Efficacy of adjuvant Nd-Yag in acne The efficacy of adjuvant Nd-Yag laser in the long-term treatment of moderate inflammatory acne and its effect on acne induced erythema and scar 2022-11-22 anticipated 21 Complete https://irct.ir/trial/66270 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual blocks will be created without stratified randomization by statistical software. And another person (rather than the doctor-researcher-patient) would do the randomization. For this, blocks of size 6 were selected for 2 treatment groups (one side of the face receiving laser treatment and the other side without treatment as a control group) so that the total sample size is 24. Accordingly, patients will receive each treatment based on the randomized sequence. N/A Acne. Intervention 1: Intervention group: Nd-YAG laser is treated on one side of the patient's face with setting and PD=25 ms and SS=4 mm. The treatment session would be 4 times every two weeks. Intervention 2: Control group: The other side of the face would receive no laser therapy. Yes - There is a plan to make this available What will be shared: The data file information of the participants - study protocol - statistical analysis plan - informed consent form will be published after de-identification. When: The access period starts 6 months after the results are published To whom: Receiving data will be available for researchers working in academic and scientific institutions or people who are also engaged in industry Conditions: In order to conduct scientific studies Where to obtain: Dr. Nika Kianfar nika_kianfar@yahoo.com How to obtain: After sending the request by providing a logical reason, the data will be sent to the person within 2 weeks. Comments:
public Nika Kianfar
No.1, afshar alley, daavi alley, pasdaran ave.
Tehran Iran (Islamic Republic of) 1947873416 +98 21 5563 0553 n-kianfar@alumnus.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Maryam Nasimi
Razi Dermatology Hospital, Razi alley, Vahdate eslami St.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 nsm.maryam@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Aged 18-60 Clinical diagnosis of moderate acne by a dermatologist 18 years 40 years Both Pregnancy or breastfeeding during the intervention history of internal diseases, including endocrine diseases causing acne Alteration in diet and lifestyle during the study Having consumed systemic therapy for acne in the last 4 weeks Having consumed oral antibiotics in the last 3 months Having consumed topical therapy for acne in the last 2 weeks Having consumed isotretinoin, undertaken laser, and peeling in the last 6 months Photosensitivity Severe or nodularis acne Polycystic ovary syndrome L70 Acne Treatment - Devices N/A Intervention group: Nd-YAG laser is treated on one side of the patient's face with setting and PD=25 ms and SS=4 mm. The treatment session would be 4 times every two weeks. Control group: The other side of the face would receive no laser therapy. Acne severity. Timepoint: At the first session and then 2 and 5 months after that. Method of measurement: Acne severity will be assessed based on Hayashi acne grading/ based on the observations of two dermatologists assessing the before and after photographs. Acne scarring. Timepoint: At the first session and then 2 and 5 months after that based on the size of the scarring in millimeters. Method of measurement: Acne scarring will be assessed based on The Goodman quantitative postacne scarring grading system / based on the observations of two dermatologists assessing the before and after photographs. Pain scoring during laser. Timepoint: At each treatment session (4 times). Method of measurement: Visual analogue scale. The side effects of laser therapy, including erythema, edema, and blisters. Timepoint: It would be evaluated after each treatment session. Method of measurement: Dermatologist's visit and patients statements. Tehran University of Medical Sciences Approved 2021-06-27 Ethics committee of Tehran University of Medical Sciences Vahdate eslami St. - Razi alley. Razi Dermatology Hospital Tehran Tehran Iran (Islamic Republic of)