The aim of this study is to compare treatment outcome of using Vitix® gel combination with NB-UVB versus NB-UVB alone in vitiligo patients referring to dermatology clinic of Quaem hospital. After explaining the objectives and methods of study and taking written consent patients older than 12 years with bilateral symmetrical vitiligo lesions distributed on face or limbs that involving more than 10% of body surface and not be pregnant or lactating or history of photosensitivity is enrolled. Each patient will be as his/her own control as while NBUVB phototherapy is administered on both sides of the body whereas Vitix ® gel is applied on just one side. The gel is applied 15-30 minutes before receiving NBUVB phototherapy which would administered three times per week on non consecutive days for 40 sessions or approximately 4 months. Selection of lesions for receiving vitix gel would be randomized for left or right side of the body. Serial photographs will taken by a single dermatologist who is blinded to using vitix gel on which side of body lesions and visit the cases monthly and calculate the repigmentation score according to a certain classification of proposal. At the end, the improvement results and side effects would be compare with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011216955N2
Registration date:2015-12-13, 1394/09/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-13, 1394/09/22
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
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2015-03-13, 1393/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding Vitix gel on vitiligo lesions treating with NB-UVB phototherapy in patients referring to dermatology clinic of Quaem hospital
Public title
Evaluation of adding Vitix gel on vitiligo lesions treating with NB-UVB phototherapy in patients referring to dermatology clinic of Quaem hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bilateral symmetrical lesions distributed on face or limbs that involving more than 10% of body surface; age>12 years; who had signed a written informed consent.
exclusion criteria: pregnancy; breast feeding; any history of previous hypersensitivity to Vitix gel; having skin malignancy; history of immunosuppression or taking immunosuppressive drugs; any contraindications for phototherapy; previous treatment with phototherapy from 3 months ago; history of photosensitivity; history of psychologic disorders
Age
From 12 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
2010-08-20, 1389/05/29
Ethics committee reference number
910996
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Lesion improvement based on amount of repigmentation
Timepoint
Monthly for 4 months
Method of measurement
Calculation the repigmentation score according to a certain classification
Secondary outcomes
1
Description
Side effects
Timepoint
Monthly
Method of measurement
Based on history, physical examination and observation of the patient
Intervention groups
1
Description
Intervention group: NB-UVB phototherapy was administered on lesions of both sides of the body, three times per week on non consecutive days for 40 sessions or 4 months.
Category
Treatment - Drugs
2
Description
Control group: Each patient acted as his/her own control as while NB-UVB phototherapy was administered on lesions of both sides of the body whereas Vitix® gel (ACM, France) was applied on just one side of the body.The gel was applied 15-30 minutes before receiving NB-UVB phototherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic,Quaem Hospital
Full name of responsible person
Dr Pouran Layegh
Street address
Department of dermatology, Quaem hospital, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of 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
Vice Chancellor for Research of 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 Pouran Layegh
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research center, Quaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
9176699199
Phone
+98 51 3801 2851
Fax
Email
layeghpo@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
Associate professor of dermatology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research center, Quaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
9176699199
Phone
+98 51 3801 2851
Fax
Email
layeghpo@mums.ac.ir; src@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health School
Full name of responsible person
Mahboobe Akhlaghi
Position
Master of Science student of Biostatistic
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Health School
City
Mashhad
Postal code
Phone
+98 51 3841 0135
Fax
Email
src@mums.ac.ir; mah1akhlaghi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)