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IRCT20170809035597N4 IRCT 2023-06-10 Iran University of Medical Sciences effect of fractional Q switch laser compared with Nd:YAG laser in the treatment of active acne of face: a single-blind randomized clinical trial Efficacy, safety, satisfaction, toleberility and treatment duribility of long-pulsed Nd:YAG 1064 nm laser compared with fractional Q-switch Nd:YAG 1064 nm laser in the treatment of active acne vulgaris in patients under treatment with azithromycine: An assessor-analyst-blinded split-body triple-arms randomized controlled clinical trial 2023-07-06 anticipated 20 Complete https://irct.ir/trial/70323 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For each patient in a random way and using sealed envelopes A and B, on one side of the face,will treated with fractional Q-switch laser and on the opposite side, Nd:YAG laser. The right side of the face of group A will treaated with Q-switch laser and the left side will treated with Nd:YAG laser and vice versa. Also, the patient's forehead or trunk acne is considered as a control group, Blinding description: The evaluation of the results of the studies will be done by a dermatologist as a blind evaluator to the type of intervention and based on the clinical images of the patients' faces in each session. Due to the clear difference between the mentioned therapeutic interventions, it was not possible to blind the therapist and as a result, the study will be conducted in a one-sided blind manner. N/A Acne. Intervention 1: Intervention group: The study population is patients with moderate to severe active facial acne referring to Hazrat Rasool Akram Hospital. Affected patients were examined by a dermatologist, and if there were entry criteria and no exit criteria, they were entered into the plan by the available method, and for each patient, fractional Q-switch laser was performed on one side of the face and Nd:YAG laser on the opposite side.Randomization is done by sealed envelopes. Each patient is treated with laser for three sessions with an interval of 3 weeks. Fractional Qswitch laser settings: Pulse rate: 10 Hz, spot size: 10 mm, fluence: 1.5 j/cm2 1064 nm Nd:YAG laser settings: Pulse rate: 4 Hz, spot size: 6 mm, fluence: 60 j/cm2.Evaluation is done in each laser sessions and 4 weeks after the last laser appointment. Intervention 2: Control group: Acne on the forehead or trunk of the patient is considered as the control 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 There is no further information
public Azadeh goodarzi
Rasoul Akram hospital ,Mansouri St, Satarkhan St, Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2390 Goodarzi.a@iums.ac.ir Iran University of Medical Sciences scientific Azadeh Goodarzi
Rasoul Akram Hospital, Mansouri St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 009864352421 Goodarzi.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patient between 15 and 50 years old Patients with a confirmed diagnosis of facial active acne During the last 3 months, the patient has not received any treatment for the disease. Lack of underlying disease The patient's cooperation in carrying out therapeutic interventions and referring for all therapeutic sessions 15 years 50 years Both The patient has been treated for acne in the last three months The presence of a serious underlying disease in the person Acne vulga L70.0 Treatment - Devices Treatment - Devices Intervention group: The study population is patients with moderate to severe active facial acne referring to Hazrat Rasool Akram Hospital. Affected patients were examined by a dermatologist, and if there were entry criteria and no exit criteria, they were entered into the plan by the available method, and for each patient, fractional Q-switch laser was performed on one side of the face and Nd:YAG laser on the opposite side.Randomization is done by sealed envelopes. Each patient is treated with laser for three sessions with an interval of 3 weeks. Fractional Qswitch laser settings: Pulse rate: 10 Hz, spot size: 10 mm, fluence: 1.5 j/cm2 1064 nm Nd:YAG laser settings: Pulse rate: 4 Hz, spot size: 6 mm, fluence: 60 j/cm2.Evaluation is done in each laser sessions and 4 weeks after the last laser appointment. Control group: Acne on the forehead or trunk of the patient is considered as the control group. Effectiveness of laser treatment on acne. Timepoint: Determining the severity of acne at the beginning of treatment and 4 weeks after the end of treatment. Method of measurement: Clinical evaluation by photographing with Canon EOS 750D digital photography camera in room light and also counting the number of active lesions 2. Determination of acne severity using Leeds revised acne grading system which is based on the lesions in the photo and comparing with existing criteria from 1 to 12 The severity of acne is scored. 3. Examining the severity of acne using the global acne grading system) which is based on the location of acne lesions on the face and also based on the type of lesions from comedone type to papule, pustule and nodulocystic acne with a score from 1 to 44 It is considered that grade 1 to 18 is mild, 19 to 30 is moderate, 31 to 38 is severe, and a grade equal to or greater than 39 is considered very severe.4. The degree of satisfaction of the doctor and the patient with the treatment based on the physician/patient global assessment score: (completely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and completely dissatisfied)The photos are reviewed and scored by a dermatologist who is blind to the study, and at the end, the study data is analyzed by a blind statistician. Safety of treatment. Timepoint: Examination of treatment side effects before and after each session and 4 weeks after the end of treatment. Method of measurement: Using doctor and patient questionnaires (including pain, swelling, erythema and PIH). Tolerability of the treatment. Timepoint: Checkiing the tolerability of the treatment before and after each session and 4 weeks after the end of the treatment. Method of measurement: Using a questionnaire (yes, no). Iran University of Medical Sciences Approved 2023-05-13 Ethics committee of Iran University of Medical Sciences Rasoul Akram Hospital, At the corner of Mansouri St,Niyayesh St, Satarkhan St Tehran Tehran Iran (Islamic Republic of)