]>
IRCT20200826048531N1 IRCT 2022-02-10 Iran University of Medical Sciences Evaluation of the effect of microneedling and N-acetylcysteine in the treatment of vitiligo Comparison of Effectiveness, Morbidity, Tolerability and Satisfaction of Vitiligo Treatment with Microneedling with N-acetylcysteine Mesotherapy Compared with Microneedling alone: a Randomized Clinical Trial 2021-12-22 anticipated 20 Complete https://irct.ir/trial/58998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is performed on 20 patients and in each patient, two lesions are selected by the therapist that are approximately appropriate in terms of location and size, and one lesion is on the right side and the other on the left side of the body or face or limbs. Simple randomization method is used in such a way that for right sided lesion by selecting the letters A, B randomly from inside the envelope, the treatment method is determined and the other method will be used for the left sided lesions. The letter A indicates the main treatment method and the letter B symbolizes the placebo, Blinding description: The study is blind for the participant and the evaluator. At the beginning of the study, the procedure of treatment and receiving the drug, randomly receiving of a main drug for one lesion and a placebo for another one, is explained for all the participants, including both the intervention group and the control group. During the treatment process, the patients, without knowing if they are receiving the main drug (N-acetylcysteine ampoule) or placebo (visually similar to the main drug), are treated. After ending the treatment, the data is provided to a dermatologist as the evaluator. This person evaluates the outcome of the study without knowing the treatment process. 3 Vitiligo. Intervention 1: Intervention group: We use 1-2 cc of Exir Pharmaceutical Company N-acetylcysteine 5% ampoule on the lesion and microneedle with NESOYA microneedling device until occurring the pinpoint bleeding, we continue the treatment sessions every two weeks up to 6 sessions and ask the patient a daily use of the combination drug N-acetylcysteine 4.7% (a combination of N-acetylcysteine powder 4.7 g and Eucerin 95.3 g) on the lesion for 2.5 months. Intervention 2: control group: We use 1-2 cc of placebo ( 5 cc distilled water of Caspian Pharmaceutical Company ) on the lesion and microneedle it for 2 minutes with NESOYA microneedling device until occurring the pinpoint bleeding, we continue the treatment sessions every two weeks up to 6 sessions. 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 more information
public Elham Ziaeifar
Rasool-E-Akram Hospital , Maziyar Mansoori Ave, Sattar khan Ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2390 elhamziaeifar@gmail.com Iran University of Medical Sciences scientific Elham Ziaeifar
Rasool-E-Akram Hospital , Maziyar Mansoori Ave , Sattar khan Ave.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2390 elhamziaeifar@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) People with vitiligo have symmetrical constants patches They are between 15-75 years old No progressive or new lesions for at least the past year They have not been treated in the last two months 15 years 75 years Both Patients who have thyroid disorders Patients with hypertrophic and keloid scars. At the site of microneedling have pathological lesions, wounds and infections. Patients who have allergies to N-acetylcysteine . Patients who are pregnant or breastfeeding. Patients who plan to become pregnant within the next six months. L80 Vitiligo Treatment - Drugs Treatment - Devices Intervention group: We use 1-2 cc of Exir Pharmaceutical Company N-acetylcysteine 5% ampoule on the lesion and microneedle with NESOYA microneedling device until occurring the pinpoint bleeding, we continue the treatment sessions every two weeks up to 6 sessions and ask the patient a daily use of the combination drug N-acetylcysteine 4.7% (a combination of N-acetylcysteine powder 4.7 g and Eucerin 95.3 g) on the lesion for 2.5 months. control group: We use 1-2 cc of placebo ( 5 cc distilled water of Caspian Pharmaceutical Company ) on the lesion and microneedle it for 2 minutes with NESOYA microneedling device until occurring the pinpoint bleeding, we continue the treatment sessions every two weeks up to 6 sessions. Tensity of lesions. Timepoint: At the beginning of the study (before the intervention) and 2, 4, 6, 8, 10 and 14 weeks after starting treatment. Method of measurement: use of Vitiligo Extent Tensity Index (VETI) score. Intensity of repigmentation. Timepoint: At the beginning of the study (before the intervention) and 2, 4, 6, 8, 10 and 14 weeks after starting treatment. Method of measurement: use of Vitiligo Extent Tensity Index (VETI) score. Treatment Tolerance. Timepoint: At the beginning of the study (before the intervention) and 2, 4, 6, 8, 10 and 14 weeks after starting treatment. Method of measurement: questionnaire (Scoring to pain from 0 to 10). Therapeutic satisfaction. Timepoint: At the beginning of the study (before the intervention) and 2, 4, 6, 8, 10 and 14 weeks after starting treatment. Method of measurement: questionnaire (Scoring from 0 to 10). Iran University of Medical Sciences Approved 2020-08-08 Ethics committee of faculty of medicine at Iran University of Medical Sciences Fifth Floor ,Office Center ,Iran University of Medical SciencesŲŒ next to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)