Effect of narrow band UVB phototherapy plus betamethasone ointment versus narrow band UVB phototherapy plus placebo ointment on the treatment of vitiligo: a double blinded randomized clinical trial
Objectives: To assess the effect of narrow band UVB phototherapy plus betamethasone ointment versus narrow band UVB phototherapy plus placebo ointment on the treatment of vitiligo.
Design: A double blinded randomized clinical trial.
Setting and conduct: All eligible patients with vitiligo who will refer to clinic of Farshchian Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) age of 7 years or older; (b) having bilateral symmetrical vitiligo lesions on upper or lower limbs, face, or trunk; (c) the vitiligo is either stable or progressive; (d) at least 10% of the body surface is affected by the disease.
Exclusion criteria: (a) being immunodeficient; (b) being spontaneous repigmentation; (c) having any contraindications for phototherapy.
Intervention: Narrow band UVB phototherapy thrice a week plus betamethasone ointment twice a day for three months.
Control: Narrow band UVB phototherapy thrice a week plus placebo (eucerin) ointment twice a day for three months.
Primary outcome: Repigmentation of the lesion based on VASI criteria in the sixth and twelfth weeks.
Secondary outcome: Evaluation of probable superficial burn through clinical observation weekly before phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402269014N26
Registration date:2014-03-09, 1392/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-09, 1392/12/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of narrow band UVB phototherapy plus betamethasone ointment versus narrow band UVB phototherapy plus placebo ointment on the treatment of vitiligo: a double blinded randomized clinical trial
Public title
Effect of narrow band UVB phototherapy plus betamethasone ointment versus narrow band UVB phototherapy plus placebo ointment on the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 7 years or older; (b) having bilateral symmetrical vitiligo lesions on upper or lower limbs, face, or trunk; (c) the vitiligo is either stable or progressive; (d) at least 10% of the body surface is affected by the disease.
Exclusion criteria: (a) being immunodeficient; (b) being spontaneous repigmentation; (c) having any contraindications for phototherapy.
Age
From 7 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Two symmetrical lesions on either side of each patient are randomly selected, one as intervention and the other as control. Thus, each patient will be compared with oneself.
Blinding: The patients will receive ointment with the same shape but different content. Thus, they will not aware of the intervention. The photos will be taken from the lesions in the sixth and twelfth weeks. Then the photos will be evaluated and compared with each other by a physician who is not aware of the intervention. Thus, the design of the study will be double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-05-16, 1391/02/27
Ethics committee reference number
D/P/16/35/9/626
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Repigmentation of the lesion
Timepoint
at the sixth and twelfth weeks
Method of measurement
based on VASI criteria
Secondary outcomes
1
Description
Evaluation of probable superficial burn
Timepoint
weekly before phototherapy
Method of measurement
through clinical observation
Intervention groups
1
Description
Narrow band UVB phototherapy thrice a week plus betamethasone ointment twice a day for three months.
Category
Treatment - Drugs
2
Description
Narrow band UVB phototherapy thrice a week plus placebo (eucerin) ointment twice a day for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Azam Dalirad
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Farshchian Hospital
Full name of responsible person
Dr Azam Dalirad
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
00
Fax
Email
a.delirrad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Amaneh Yazdanfar
Position
Dermatologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
00
Fax
Email
yazdanfar@usmsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)