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
Determining the effectiveness of NB-UVB phototherapy combined with oral N-acetylcysteine (NAC) in comparison with NB-UVB phototherapy alone in the treatment of vitiligo
Design
A randomized clinical trial with a control group, parallel groups, singe-blind, phase 3 on 40 patients, randomization is performed through a table of random numbers.
Settings and conduct
This study will be performed on 40 patients in Rasoul Akram Hospital in a four-month treatment period. Patients will be divided into two groups of 20: one group of oral NAC with NB-UVB phototherapy and the other group with NB phototherapy. -They will receive the UVB alone as a control group. This blind study is conducted by a researcher and analyzer and sealed envelopes are used for concealment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with generalized vitiligo.
Exclusion criteria: Patients with focal or segmental vitiligo, patients with other skin or systemic diseases, history of peptic ulcer, photosensitivity, patients who have received systemic or topical medication for two months.
Intervention groups
Patients enter the intervention in two groups of 20 people, one group will receive oral NAC along with NB-UVB phototherapy and the other group will receive NB-UVB phototherapy alone as a control group.
Main outcome variables
Vitiligo severity score; patient's satisfaction with the treatment; patient's tolerance of the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210729052013N1
Registration date:2021-12-04, 1400/09/13
Registration timing:prospective
Last update:2021-12-04, 1400/09/13
Update count:0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Saeideh Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2262 3759
Email address
farahani.104@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the efficacy of oral N- acetylcysteine in the treatment of vitiligo patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with generalized vitiligo who volunteer for NB-UVB phototherapy
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
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.
Secondary outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.