Objectives: To compare the efficacy of Erbium YAG laser plus cream 5 Fluorouracil and cream clobetasole with cream 5 Flurouracil and cream clobetasole alone for treatment of vitiligo. Major Inclusion and Exclusion criteria: Inclusion criteria:vitiligo patients with at least two patches on their trunk and extremities excepting periungual areas or genitalia with no perifollicular pigmentation or depigmented hair Exclusion Criteria:patients with poor compliance ; pregnancy; lactation; hepatic or hematologic or renal diseases ; simultaneous application of other therapies. Setting and Conduct: 37 patients having at least two vitiligo patches were selected . after obtaining their consents ,in a dermatology clinic setting, two treatment methods are randomly allocated to the two lesions in each patient: one lesion is treated with cream clobetasole 0.05% and cream 5fluorouracil 5% once every other day for two months, and the other , with one session of laser Erbium YAG ( with spot size 2-4 mm and energy 200-500 jouls) until the pin point bleeding establishment ( usually 3 passes ). Immediately after lasering , cream 5 Fluorouracil 5% is applied to the lesion for 2 days . The cream clobetasole 0.05% every other day – 2 months treatment is then conducted. At the end of month two , the conditions of the lesions size, pigmentation scores and complications are assessed and two groups are compared . 2 months after treatment completion accordingly, the patients are revisited for pigmentation score and lesion size. SPSS statistical tests are used to obtain the research objectives.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090229647N1
Registration date:2016-09-17, 1395/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-17, 1395/06/27
Registrant information
Name
Anis Bostakian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
a.bostakian@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness comparison of topical 5 fluorouracil and clobetasole combined treatment with/without laser Erbium YAG in vitiligo patients reffering to Isfahan educational clinics
Public title
The effect of laser and cream 5 fluorouracil 5% in treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion/exclusion criteria:
Inclusion criteria: Age ≥15 years; patient suffering from vitiligo with at least 2 patch on limbs or trunk( except periungual areas and genitalia); no follicular pigmentation and depigmented hair on lesion Exclusion Criteria: Incidence of drug adverse effects; patients with poor compliance for visit and follow up; pregnancy and lactation; patients with hepatic or hematologic or renal disease; simultaneous application of other therapies .
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2016-02-06, 1394/11/17
Ethics committee reference number
IR.muI.REC.1394.3.875
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
vitiligo
Primary outcomes
1
Description
Vitiligo lesion size change and pigmentation score
Timepoint
2 months and then 4 months after treatment start
Method of measurement
by pictzar software and pigmentation score for vitiligo by an independent dermatologists blinded to the randomization
Two days, one week , two months and four months after treatment start
Method of measurement
Visit, history and physical examination
Intervention groups
1
Description
One of the lesion is randomly treated using one session of Erbium YAG laser( with spot size 2-4 mm and energy 200-500 jouls)until the pinpoint bleeding establishment ( usually 3 passes ) . Immediately after lasering , cream 5 Fluorouracil 5% is applied to the treated region once a day for only two days and cream clobetasole 0.05% is then applied once every other day for two months.
Category
Treatment - Devices
2
Description
In the other lesion, cream 5 Fluorouracil 5% and cream clobetasole 0.05% are applied once every other day for two months with no laser therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Al Zahra Hospital
Full name of responsible person
Dr Anis Bostakian
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Noor and Hazrat-e-Ali Asghar Hospital
Full name of responsible person
Dr Anis Bostakian
Street address
City
Isfahan
3
Recruitment center
Name of recruitment center
Sedighe tahere center
Full name of responsible person
Dr Anis Bostakian
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nemat bakhsh
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Isfahan 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
Isfahan university of medical science
Full name of responsible person
Anis Bostakian
Position
resident of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd