Comparative efficacy of 0.1%Tacrolimus ointment versus 0.005% Calcipotriol ointment in perifollicular pigmentation in patients with hand and facial vitiligo
The present study is a randomized double-blind clinical trial. The aim of this study is to compare the efficacy of 0.1%Tacrolimus ointment versus 0.005% Calcipotriol ointment in reducing perifollicular pigmentation in patients with hand and facial vitiligo. The study will be conducted in the dermatology clinic of the Sina hospital in Tabriz. Seventy patients with hand and facial vitiligo will be recruited. The patients should be older than 2 years old, willing to participate in the study and should not have any other diseases which can affect the response of the patient to the treatment.
All patients will be assessed by a dermatologist at baseline of the study, then will be entered into either group A or B. Patients in group A and B will be administered 0.005% Calcipotriol and 0.1% Tacrolimus respectively. The patients will be blind to the type of ointment they use. The amount of ointment used by the participants will be similar for the two groups and it will be applied on the lesions once every night. The degree of perifollicular pigmentation is considered as the primary outcome in this trial. The patients will be followed monthly for one year and the assessment of the outcomes (perifollicular pigmentation, number and size of the lesions) will be performed by a dermatologist who is blind to the type of ointment used by the patient. Every month, a photograph will be taken from the patients using a 12.1 mega pixel Cannon camera with a lens zoom of 4*15. After final assessments of the participants and recording their data in the checklists, statistical analyses will be performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208144269N4
Registration date:2012-10-10, 1391/07/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-10-10, 1391/07/19
Registrant information
Name
Farideh Golfroushan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 2101
Email address
golfroushanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-29, 1391/09/09
Expected recruitment end date
2014-06-29, 1393/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of 0.1%Tacrolimus ointment versus 0.005% Calcipotriol ointment in perifollicular pigmentation in patients with hand and facial vitiligo
Public title
Comparative efficacy of Tacrolimus ointment versus Calcipotriol ointment in vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Being older than 2 years old; 2) Vitiligo patients in which less than 20% of the face and hands are affected; 3) Willing to participate in the study
Exclusion criteria:
1) History of herpes, dermatitis herpetiformis and any kind of active skin infections; 2) Patients with autoimmune hepatitis; 3) Patients with celiac disease; 4) Patients with immune system deficiency; 5) Pregnant or lactating women; 6) Patients with unknown systemic disorders; 7) Having simultaneous skin diseases other than vitiligo, malignancies or renal disorders
Age
From 2 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients will be randomized into group A or B, using table of random numbers and the software RAND list. The ointments will be provided in plastic containers. Code A or B will be used for the containers. The physician, who will assess the patients monthly, will be different than the one who will prescribe the ointments to the patients at the baseline of the trial. Thus, the study will be double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad Ave., Daneshgah St. Tabriz, Iran
City
Tabriz
Postal code
Approval date
2012-06-11, 1391/03/22
Ethics committee reference number
5/4/2703
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Perifulicular pigmentation
Timepoint
At baseline and monthly for one year
Method of measurement
Photographs will be taken from the patients using a 12.1 mega pixel Cannon camera which has a lens zoom of 15*4.
Secondary outcomes
1
Description
Number of the lesions
Timepoint
At baseline and monthly for one year
Method of measurement
Counting visually
2
Description
Size of the lesions
Timepoint
At baseline and monthly for one year
Method of measurement
Evaluating the photographs taken from the lesions
Intervention groups
1
Description
Tacrolimus ointment (0.1%) manufactured by "Quality Care" which will be rubbed on the lesions once every night for one year. The weekly dosage used will be less than 100 grams.
Category
Treatment - Drugs
2
Description
Calcipotriol ointment (0.005%) with the trade name of "Daivonex" manufactured by "Quality Care" which will be rubbed on the lesions once every night for one year. The weekly dose of the ointment will be less than 100 grams to avoid probable hypercalcemia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Farideh Golfroushan
Street address
Dermatology Word, Sina Hospital, Azadi St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Golbad Ave., Daneshgah St., 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
Vice Chancellor for Research, 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
Farideh Golfroushan
Position
Dermatologist
Other areas of specialty/work
Street address
Golgasht Ave., Daneshgah St., Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
golfroushanf@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farideh Golfroushan
Position
Dermatologist
Other areas of specialty/work
Street address
Golgasht Ave., Daneshgah St., Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
golfroushanf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Faegheh Sheikhalizade Nobar
Position
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
faegheh.alizadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)