Objectives: To compare the efficacy of topical betametazon versus topical tacrolimus 0.1% in the treatment of vitiligo
Design: Clinical trial study
Setting and conduct: Randomized clinical trial study
Participants including major eligibility criteria: Sixty patients with vitiligo over 2 years old and less than 30% of body surface area will be evaluated.
Intervention: The first group wiill receive tacrolimus 0.1 % cream and the second group will receive topical betamethasone. Patients during the first 6 months (every month) and in the second six months (every two months ) will be examined.
Main outcome measures: The efficacy, improvment and side effects of each treatment will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311295605N6
Registration date:2014-02-13, 1392/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-13, 1392/11/24
Registrant information
Name
MOHAMAD GOLDUST
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133614711
Email address
medres@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-10-01, 1392/07/09
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial study in the comparison of topical betametazon versus topical tacrolimus 0.1% in the treatment of vitiligo
Public title
The effect of topical betametazon versus topical tacrolimus 0.1% in the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with vitiligo over 2 years old and less than 30% of body surface area involved.
Exclusion criteria: Patients with allergy or hypersensitivity to macrolides; Pregnant and lactating women; Patients with immune deficiency and patients who had received vitiligo medications less than 6 months ago
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
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
Ethic committee of Tabriz university of medical sciences
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
5166614711
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
9098
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Severity of vitiligo skin lesion
Timepoint
6 month
Method of measurement
Clinical assesment
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, 30 patients wiill receive tacrolimus 0.1 % cream and during the first 6 months (every month) and in the second six months (every two months ) will be examined.
Category
Treatment - Drugs
2
Description
In the control group, 30 patients will receive topical betamethasone and during the first 6 months (every month) and in the second six months (every two months ) will be evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Ramin Mirmohammadi
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Ramin Mirmohammadi
Position
Resident in dermatology
Other areas of specialty/work
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
5166614711
Phone
+98 41 1545 2206
Fax
+98 41 1336 8805
Email
ramin.rms@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Shahla Babaei nejad
Position
Associate professor in dermatology
Other areas of specialty/work
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+41 15453368805
Fax
Email
drshbabaie@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)