Many medical treatments have been attempted with partial success for vitiligo, but there is no previous trial on combination of topical 5FU 5% and clobetasol. .
This double-blind clinical trial from November 2009 to August 2011 on patients admitted to the educational clinics vitiliginous skin was performed. 45 patients were enrolled. Each patient with two patches was selected that for one side clobetasol cream and other side clobetasol and 5fu for 3 months, every other day was administered.pigmentation score was evaluated at the end of treatment. Inclusion criteria were as follow: vitiligo patients with at least 2 lesions on the body, >15 years old, lack of follicular pigmentation (score=0), lack of white hair over the lesion and disease stability within the last 6 months.
Exclusion criteria were as follow: those who had recieved topical medication for at least 1 month and systemic medication or phototherapy for at least 3 months prior to inclusion; past medical history of liver, kidney and hematologic disorders; the vitiligo lesions on the face, genitalia or acral areas; pregnancy or lactation and the segmental subtype.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203049198N2
Registration date:2012-04-01, 1391/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-01, 1391/01/13
Registrant information
Name
Fatemeh Mokhtari
Name of organization / entity
Isfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1444 6330
Email address
f_mokhtari@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of topical clobetasol 0.05% plus 5FU 5% cream vs. topical clobetasol 0.05% alone in the treatment of vitiligo.
Public title
Comparison of efficacy of topical clobetasol 0.05% plus 5FU 5% cream vs. topical clobetasol 0.05% alone in the treatment of vitiligo.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were as follow: vitiligo patients with at least 2 lesions on the body, >15 years old, lack of follicular pigmentation (score=0), lack of white hair over the lesion and disease stability within the last 6 months.
Exclusion criteria were as follow: those who had recieved topical medication for at least 1 month and systemic medication or phototherapy for at least 3 months prior to inclusion; past medical history of liver, kidney and hematologic disorders; the vitiligo lesions on the face, genitalia or acral areas; pregnancy or lactation and the segmental subtype. Patients were instructed about the study protocol, possible side effects and a written informed consent was taken from all patients before enrollment.
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
not used
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Univercity of Medical Sciences
Street address
Isfahan Univercity of Medical Sciences, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Approval date
2009-10-23, 1388/08/01
Ethics committee reference number
388456
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
vitiligo
Primary outcomes
1
Description
Lesion of vitiligo
Timepoint
End of three months
Method of measurement
Pigmentation score
Secondary outcomes
1
Description
erythema,atrophy,erosion
Timepoint
any time during treatmrnt
Method of measurement
observation
Intervention groups
1
Description
In control group: Clobetasol 0.05% cream for topical use over the selected lesion on the left side of the body was given to patient . we recommended that patient use the drug every other day,once a day. The duration of study was three months.
Category
Treatment - Drugs
2
Description
In interventionl group: Clobetasol 0.05% cream plus 5FU5% cream for topical use over the selected lesion on the right side of the body was given to patient . we recommended that patient use the drug every other day,once a day. The duration of study was three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
skin educational clinics
Full name of responsible person
dr.zabihollah shahmoradi
Street address
Alzahra hospital, Soffeh Blvd, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
Dr.Peyman Adibi
Street address
Isfahan Univercity of Medical Sciences, Soffeh Blvd, Isfahan
City
Isfahan
Grant name
388456
Grant code / Reference number
388456
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Univercity 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
Isfahan Univercity of Medical Sciences
Full name of responsible person
dr.zabihollah shahmoradi
Position
Assistant professor of Dermatology
Other areas of specialty/work
Street address
Isfahan Univercity of Medical Sciences, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1666 6666
Fax
+98 66 66666
Email
shahmoradi@mui.ac.ir
Web page address
shahmoradi@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
dr.zabihollah shahmoradi
Position
Assistant professor of Dermatology
Other areas of specialty/work
Street address
Isfahan Univercity of Medical Sciences, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1666 6666
Fax
+98 31 1666 6666
Email
shahmoradi@mui.ac.ir
Web page address
shahmoradi@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Univercity of Medical Sciences
Full name of responsible person
dr.fatemeh mokhtari
Position
resident of skin
Other areas of specialty/work
Street address
Isfahan Univercity of Medical Sciences, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1666 6666
Fax
Email
f_mokhtari@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)