Evaluation of efficacy of microdermabrasion in association with Tacrolimus ointment plus Elocome ointment in compare with pimecrolimus ointment plus Elocome oint in patients with vitiligo
In this survey we will assay the effect of microdermabration in combination with Tacrolimous ointment and Elacomin ointment in treatment of vitiligo. It has been designed as a single-blind randomized clinical trial. 47 patients with vitiligo will be included in the study through the inclusion criteria of men and women aged 18 to 70 years; able to read, understand and sign patient informed consent; presenting with at least two patches symmetrically on both sides of the body, with the lesions being stable for more than 6 months prior to the study. The use of all topical medications should be discontinued for two weeks before recruiting the patients to the study. Subjects should also discontinue their phototherapy from one month previous to the study. An 8-weeks treatment of Picrolimous (twice a day) & Elacom (1week, daily /1week withdrawal) will be taken to the patients, and Microdermabration is prescribed every 2 weeks with single direction patches from the normal skin of the periphery to the depigmented center of the lesion. The patients with abnormal liver function tests & thyroid test; any evidence of local infection at the site of intervention, any evidence of spontaneous re-pigmentation; pregnancy and lactation; and subjects who state no satisfaction to participate at any stage of the study will be excluded. The outcomes of the survey will be considered as the recovery rates after two months of treatment; according to the assessment of two dermatologists based on the digital photos will be taken at each sessions (score 0-4).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212059800N3
Registration date:2013-08-06, 1392/05/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-06, 1392/05/15
Registrant information
Name
Parvin Mansouri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 5911
Email address
mansorip@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin stem cell research center-Tehran university of medical sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of microdermabrasion in association with Tacrolimus ointment plus Elocome ointment in compare with pimecrolimus ointment plus Elocome oint in patients with vitiligo
Public title
Evaluation of efficacy of microdermabrasion in association with Tacrolimus oint plus Elocome oint in compare with pimecrolimus oint plus Elocome oint in patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age range 18 to 70 years; existence of 2 vitiligo symmetrical patch in both side of body; not taking local drugs from 2 weeks before the study; no photo therapy from one month before the study; stable for 6 months prior to study.
Exclusion criteria: evidence of local infection at the site of testing; evidence of spontaneous re-pigmentation; abnormal liver function tests & thyroid tests; pregnant and lactating mothers; no satisfaction to participate at any stage of the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
47
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
Tehran University of Medical Science and Health Service
Street address
Central administration of university, Ghodss St., Keshavarz Blvd
City
Tehran
Postal code
1417653761
Approval date
2012-09-30, 1391/07/09
Ethics committee reference number
91-03-150-19555-77316
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
One of the common pigmentation disorders , Depigmented pathes in diffrent size
Primary outcomes
1
Description
Patient Clinical Healing
Timepoint
In the weeks 0, 2, 4, 6 & 8
Method of measurement
According to two dermatologist assessment based on digital photos of therapeutic sessions (score 0-4).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Microdermabration combined with two topical cream (Tacrolimous + Elocome)
Category
Treatment - Devices
2
Description
Intervention2: combination of two topical creams (Tacrolimous + Elocome)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin clinic of Imam Khomeini hospital
Full name of responsible person
Dr. Parvin Mansouri
Street address
Imam Khomeini hospital, Kheshavarz BLV.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Parvin Mansouri
Street address
Skin Ward, Imam Khomeini Hospital,Kheshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?