This study aims to evaluate the effects of P-NB UVB and NB-UVB radiations in treating Generalized Vitiligo. In this study 60 patients with Generalized vitiligo who have between 5 to 60 percent body skin involvement are enrolled. Patients are requested to fill out consent forms. Then using a computer software, patients are respectively divided into 2 groups by random. Patients of Group A and group B are placed under P-NB UVB and NB UVB phototherapy treatment. Patients of group A, two hours before each phototherapy session, receive 8-Metoxi Pesoralen tablet with 0.6 mg/kg dose. Patients in both groups then have 3 phototherapy sessions in non-consecutive days each week. The initial UVB dose in both groups is 0.25 J/cm2 and if tolerated, it will be increased by 20 percent each session. Increasing or not increasing the UVB dose depends on the maximum erythema observed in previous session. Patients are recommended to protect their eyes and cover the genital area with enough clothing. Patients are also requested to be under minimum sun exposure. The treatment is ended in the events of 1: approximate or total disappearance of Vitiligo 2: no improvement after 32 sessions or very slow improving process 3: intolerance against treatment due to local or systemic side effects. All patients, before starting treatment and after each 20 sessions are evaluated with photos taken of them (using a camera in the same place and light exposure). The extent of lesion is measured in each evaluation and depigmentation grading is also done. The main results of this study is investigating the efficiency of P-NB UVB in treating vitiligo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052816955N6
Registration date:2017-06-08, 1396/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Pouran Layegh
Name of organization / entity
department of dermatology, Ghaem hospital, Mashhad, Iran
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2861
Email address
momenzadeha1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Psoralen–narrowband UVB and narrowband UVB in treating Vitiligo
Public title
Comparison of two photo therapy methods in treating Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with generalized Vitiligo who have 5 to 60 percent body involvement; filling out consent form by patient; age over 13 years old
Exclusion criteria: patients who have been under phototherapy or photochemotherapy during 3 months before study starts; patients who have had over 100 phototherapy or photochemotherapy sessions before; pregnancy or breast feeding; heart, kidney and liver disease; children under 13 years old; history of photosensitivity or any dermatosis created by UV light like Lupus Erythematosus; history of previous skin malignancy; history of cataract
Age
From 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-07-22, 1394/04/31
Ethics committee reference number
IR.MUMS.fm.REC.1394.212
Health conditions studied
1
Description of health condition studied
Generalized vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Extent of lesion
Timepoint
Before starting treatment and after each 20 sessions
Method of measurement
Taking photos and measuring in hand unit and each hand unit is equal to 1 percent
Secondary outcomes
empty
Intervention groups
1
Description
Photo therapy using NB-UVB with initial dose of 0.25 J/cm2 three sessions in a week plus 8-Metoxi Pesoralen with dose of 0.6mg/kg two hours before photo therapy.
Category
Treatment - Drugs
2
Description
Photo therapy using 0.6mg/kg with initial dose of 0.25 J/cm2 three sessions in a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Zahra Ashrafi
Street address
Ghaem Hospital Ahmad Abad Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Zahra Ashrafi
Position
Dermatology Assistant
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 51 3801 2493
Fax
Email
src@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Professor of dermatology
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 51 3801 2861
Fax
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Professor of Dermatology
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)