Comparison of Effectiveness, Morbidity, Tolerability and Satisfaction of Vitiligo Treatment with Microneedling with N-acetylcysteine Mesotherapy Compared with Microneedling alone: a Randomized Clinical Trial

Evaluation of Effectiveness, side effects, tolerability and satisfaction of microneedling therapy with N acetylcysteine in the treatment of stable vitiligo

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 20 patients. A simple randomization method is used.

Patients are selected from the dermatology clinic of Rasoul Akram Hospital and treatment and follow-up sessions are held in weeks 0, 2, 4, 6, 8, 10, 14. duration of each session is 15 minutes. In this study, participants and the evaluator were blinded so that patients were not informed about the drug used and the evaluator was not aware of the treatment process.

Inclusion criteria: People with symmetrical stable vitiligo who are between 15-75 years old and have not progressive lesions or new lesions in at least the past year and have not been treated in the past two months. Exclusion criteria: Patients who have thyroid disorders or allergy to N-acetylcysteine, are pregnant or breastfeeding, or intend to become pregnant within the next six months, patients who have a history of hypertrophic and colloidal scars, or pathological lesions , sores and infections at the site of microneedling .

Intervention group: we use 1-2 cc of Exir Company 5% N-acetylcysteine ampule on the lesion and microneedle it until occurring the pinpoint bleeding. 4.7% N-acetylcysteine cream ( 4.7 g N-acetylcysteine powder in 95.3 g Eucerin ) is also use once a day for 2.5 months and treatment sessions continue for 6 sessions every two weeks. Control group: we use distilled water on the lesion as a placebo and microneedle it until occurring the pinpoint bleeding. the treatment continue for 6 sessions every two weeks

Tensity of lesions, Intensity of repigmentation, Treatment Tolerance, Treatment satisfaction

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.

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.