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IRCT20210729052013N1 IRCT 2021-12-04 Iran University of Medical Sciences Evaluation of the efficacy of oral N- acetylcysteine in the treatment of vitiligo patients Evaluation of the efficacy of NB-UVB phototherapy with oral N- acetylcysteine compared with NB-UVB phototherapy alone in the treatment of vitiligo patients: a randomized controlled clinical trial 2021-12-11 anticipated 40 Complete https://irct.ir/trial/60059 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used and the tool used is a random number table. Numbers reading is from top to bottom. Even numbers are considered for intervention a and odd numbers for intervention b. Code a will be used for oral acetylcysteine and NB-UVB phototherapy and code b will be used for NB-UVB phototherapy alone. Sealed envelopes will be used for concealment, Blinding description: Participants are invited to study and after obtaining informed consent are divided into intervention and control groups. The lead researcher will study the patients' sampling, recording, and follow-up, and at each visit the second researcher, who is blind, will calculate the Vitiligo Extent Tensity Index (VETI) score, which will be completed by the lead researcher in the questionnaire. Finally, the blind analyzer will perform statistical calculations of this study according to codes a and b. 3 vitiligo disease. Intervention 1: intervention group: Participants in the intervention group are treated with Dr Honle Drmalight 3000 phototherapy device with a wavelength of 311 nm 3 times a week for four months. The initial dose for each patient is 65 mj / cm2 and increases by 65 ml. Joules per square centimeter in each session is adjusted to a dose of 1000 millijoule per square centimeter. In addition to phototherapy, the group received oral N-acetylcysteine tablets (manufactured by Avesina), an antioxidant derived from the amino acid cysteine, at a dose of 600 mg, twice daily, starting two weeks before the start of NB-UVB until the end. 4 months is also received. Intervention 2: Control group: Participants in the Control group are treated with Dr Honle Drmalight 3000 phototherapy device with a wavelength of 311 nm 3 times a week for four months. The initial dose for each patient is 65 mj / cm2 and increases by 65 ml. Joules per square centimeter in each session is adjusted to a dose of 1000 millijoule per square centimeter. 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 "No more information"
public Saeideh Farahani
No.2, Hadi Mohammad Alley, Khaghani St, Shariati St
Tehran Iran (Islamic Republic of) 1916963568 +98 21 2262 3759 farahani.104@gmail.com Iran University of Medical Sciences scientific Saeideh Farahani
No. 2, Hadimohammad Alley, Atarimoghadam Ave.,Khaghani Ave.,Shariati Ave.,Zargande
Tehran Iran (Islamic Republic of) 1916963568 +98 21 2262 3759 farahani.104@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) People with generalized vitiligo who volunteer for NB-UVB phototherapy no limit no limit Both Patients with focal or segmental vitiligo Patients with other skin diseases Patients with a history of gastrointestinal ulcers Patients with photosensitivity Patients who have received systemic or topical medication for 2 months Pregnant and lactating women L80 Vitiligo Treatment - Drugs Treatment - Devices intervention group: Participants in the intervention group are treated with Dr Honle Drmalight 3000 phototherapy device with a wavelength of 311 nm 3 times a week for four months. The initial dose for each patient is 65 mj / cm2 and increases by 65 ml. Joules per square centimeter in each session is adjusted to a dose of 1000 millijoule per square centimeter. In addition to phototherapy, the group received oral N-acetylcysteine tablets (manufactured by Avesina), an antioxidant derived from the amino acid cysteine, at a dose of 600 mg, twice daily, starting two weeks before the start of NB-UVB until the end. 4 months is also received. Control group: Participants in the Control group are treated with Dr Honle Drmalight 3000 phototherapy device with a wavelength of 311 nm 3 times a week for four months. The initial dose for each patient is 65 mj / cm2 and increases by 65 ml. Joules per square centimeter in each session is adjusted to a dose of 1000 millijoule per square centimeter. Vitiligo severity score. Timepoint: At the beginning of the study (before the intervention), 2 and 4 months after the start of treatment. Method of measurement: Vitiligo Extent Tensity Index (VETI) score, which its maximum value is 55.5. The patient's satisfaction with the treatment. Timepoint: Measurement periods: 2 and 4 months after starting treatment. Method of measurement: At each visit, patients determine their level of satisfaction by choosing one of the following options: 1. No 2. A little 3. Moderate 4. Good 5. Excellent. The patient's tolerance of the treatment. Timepoint: Measurement periods: 2 and 4 months after starting treatment. Method of measurement: At each visit, patients determine their tolerance by choosing one of the following options: 1. Yes 2. No. Iran University of Medical Sciences Approved 2020-10-31 Ethics committee of Iran University of Medical Sciences No.2, Hadi Mohamad Alley, Atari Moghadam Ave, Khaghani Ave, Shariati Ave Tehran Tehran Iran (Islamic Republic of)