Comparison between the efficacy of NBUVB phototherapy with or without needling and intralesional synacthen (tetracosactide) in the treatment of patients with refractory lesions of vitiligo
ِDetermination of efficacy of NBUVB phototherapy with or without needling and intralesional synacthen (tetracosactide) in the treatment of patients with refractory lesions of vitiligo
Design
clinical trial with control group, Community based, Prospective study, randomized
Settings and conduct
This is a randomized clinical trial that was conducted in 1397 and 1398 on patients referred to the Al-Zahra Hospital and Espasadana Laser Center in Isfahan.
In this study, a number of patients with refractory vitiligo who were referred to the Al-Zahra and Espadana Laser Center for NBUVB were selected randomly and after receiving consent to participate in the study, a group of patients undergoing treatment With NBUVB and the other group treated with NBUVB and needling with intalesional cynacthen once a week for three months and then grade of repigmentation evaluated in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Patients with refractory vilitigo with less than 50% skin lesion
2-patches with dimensions of 1-8 cm in two-sided form
3-inactivity of disease during 6 last months
exclusion criteria:
1-segmental vitiligo
2-activity of disease during 6 last months
Intervention groups
In this study, two groups of 34 patients are be studied. First group are being treated with photo therapy and the other one are being treated with photo therapy and needling with intralesional cynacthen.
Main outcome variables
A new way to treat vitiligo with the least side effects and high effectiveness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190515043600N1
Registration date:2019-05-23, 1398/03/02
Registration timing:retrospective
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Hossein Farmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5222 0849
Email address
farmanihossein@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy of NBUVB phototherapy with or without needling and intralesional synacthen (tetracosactide) in the treatment of patients with refractory lesions of vitiligo
Public title
Effect of Needling with intralesional synacthen injection in treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with refractory vitiligo with less than 50% skin leison
patches in the size of 1-8 cm in two-sided form
Inactivity of disease during the last 6 months
Exclusion criteria:
Segmental vitiligo
Activity of vitiligo in the last 6 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, two groups of 34 people are studied. After getting informed consent from the patient، treatment begins and patient's treatment process is evaluated.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of medical science, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.MUI.MED.REC.1398.073
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Grade of Repigmentation
Timepoint
At the beginning of the study and three months later
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Vitiligo skin lesions
Timepoint
ابتدای مطالعه و 3 ماه بعد
Method of measurement
Percentage
Intervention groups
1
Description
Intervention group: NB-UVB Photo therapy and Needling with Intraesional Synacthen Injection
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز جراحی پلاستیک و لیزر اسپادانا
Full name of responsible person
دکتر علی اصیلیان
Street address
Golshan Alley, Mohtasham Kashani Ave, Hakim Nezami Ave
City
Isfahan
Province
Isfehan
Postal code
8175979653
Phone
+98 31 3625 6981
Email
info@spadanalaser.ir
Web page address
http://www.spadanalaser.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
دکتر شقایق حق جوی جوانمرد
Street address
Isfahan University of Medical Sciences, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?