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IRCT20150529022468N6 IRCT 2023-08-12 Iran University of Medical Sciences Comparison of the efficacy and safety of PDL, IPL and long pulse Nd:Yag 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris Comparison of the efficacy and safety of PDL, IPL and Q switch Nd:YAG 1064 laser in the treatment of mild to moderate inflammatory acne vulgaris 2023-10-02 anticipated 36 Complete https://irct.ir/trial/71623 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Over time, patients are randomly divided into three groups. The method of randomization is *Random allocation rule*. A representative of the first, second and third groups is written and placed inside envelopes and in order to perform a random sequence (allocation concealment) on the participants, the table of random numbers will be used, Blinding description: A representative of the first, second, and third groups is written and placed inside opaque envelopes (which cannot be seen inside the envelope). Participant are blinded to the intervention until the end of the study. 2 Infammatory facial Acne vulgaris. Intervention 1: Intervention group 1: Patients in the first group were treated 3 times with an interval of two weeks with PDL laser with a wavelength of 585 nanometers, laser spot diameter of 7 mm, fluence of 3 joules, and pulse duration of 350 microseconds. Intervention 2: Intervention group 2: In the second group, patients are treated 3 times with an interval of two weeks with IPL laser with a wavelength of 240-1200 nanometers and fluence of 7 joules. Intervention 3: Intervention group 3: In the third group, patients are treated 3 times with an interval of two weeks with Nd: Yag long pulse laser with a wavelength of 1064 nanometers and a fluence of 40 joules and a pulse duration of 40 microseconds. Yes - There is a plan to make this available What will be shared: Individual Data: All potentially shareable data after de-identifying individuals. Study protocol: The entire protocol can be shared after de-identifying people. Statistical analysis map: The whole map can be shared after de-identifying people. Informed Consent Form: Can be shared after de-identifying individuals. Clinical Study Report: The entire report can be shared after de-identifying individuals. Codes used in the analysis: All codes can be shared after de-identifying people. Data classification system: It can be shared after de-identifying people. When: The access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: In case of research on a similar topic, he/she can use the data of this study. Where to obtain: 1- Email: Keramatihaniyeh73@gmail.com 2- Postal address: Rasool Akram Hospital, Mansouri St., Sattar Khan Ave., Tehran How to obtain: After correspondence via e-mail or postal address, it is possible to receive data and documents within a period of about two months, if the researcher wishes. Comments:
public Mohammadreza Ghassemi
Rasoul Akram hospital, Mansouri street, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2390 Ghassemi.mr@iums.ac.ir Iran University of Medical Sciences scientific Mohammadreza Ghassemi
Rasoul Akram hospital, Mansouri street, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2390 Ghassemi.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Participants over 18 years old with mild to moderate facial inflammatory acne Not taking isotretinoin in the last 6 months. 18 years no limit Both History of hypertrophic scar or keloid Anticoagulant drug consumption in the last 2 months Pregnancy or breastfeeding Photosensitivity and rheumatologic diseases Dissatisfaction of patients L70.0 Acne vulgaris Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: Patients in the first group were treated 3 times with an interval of two weeks with PDL laser with a wavelength of 585 nanometers, laser spot diameter of 7 mm, fluence of 3 joules, and pulse duration of 350 microseconds Intervention group 2: In the second group, patients are treated 3 times with an interval of two weeks with IPL laser with a wavelength of 240-1200 nanometers and fluence of 7 joules. Intervention group 3: In the third group, patients are treated 3 times with an interval of two weeks with Nd: Yag long pulse laser with a wavelength of 1064 nanometers and a fluence of 40 joules and a pulse duration of 40 microseconds. Leeds revised acne grading system. Timepoint: Checking the severity of acne at the beginning of the study and on days 14, 28 and 42 after the intervention. Method of measurement: Based on the number of lesion in the photo and comparing with "Leeds revised acne grading system" a score of 1-12 is given. Severity of inflammatory facial acne. Timepoint: Measuring the criteria of the global acne grading system at the beginning of the study and on the 14th, 28th, and 42nd days after the start of the study. Method of measurement: Based on the type of lesions, from comedone type to papule, pustule and nodulocystic acne, a score is given from 1 to 44. Quality of life index. Timepoint: Beginning and end of the study (0 and 42th days). Method of measurement: "Dermatology Life Quality Index " questionnaire. Iran University of Medical Sciences Approved 2023-04-18 Ethics committee of Iran University of Medical Sciences Iran university of medical sciences, Central headquarters building, Research and technology vice-chancellor, next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)