The objective of this randomized, double blind trial is to investigate the effect of topical various formulation of hydroalcoholic extract from fumaria officinalis on vitiligo. In this study 75 patients with vitiligo who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive formulation for one symmetric section of the patches. The patients in the control group will receive none of the topical drug. In-vitro tests include: the methods of assigning the fumaric acid by HPLC, release test, viscosity and permanence test for every six formulation were done. The patients are classified into six groups, and every formulation is used for 16 weeks, then the degree of recovery was controlled in every 15 days. As regards that the patients use the formulation for one symmetric section of their bodies; it is possible to compare the patches of two symmetric sections of the body in order to find the signs of recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111108022N1
Registration date:2011-12-08, 1390/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-08, 1390/09/17
Registrant information
Name
Katayoun Derakhshandeh
Name of organization / entity
Hamadan University of Medical Sciences, Pharmacy school
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1590
Email address
kderakhshandeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research department of pharmacy school of Kermanshah University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of different topical formulations of Fumaria officinalis extract on the Vitiligo and analysis of its Fumaric acid content by HPLC.
Public title
Clinical evaluation of different topical formulations of Fumaria officinalis extract on the Vitiligo and analysis of its Fumaric acid content by HPLC.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lasting more than 6 month after diagnosis, age 11-60, filling informed consent. Exclusion criterion: Pregnancy, Lactation, not filling consent form.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kermanshah University of Medical Sciences and Health Services
Street address
Beheshti blv, Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2010-12-20, 1389/09/29
Ethics committee reference number
7/420/12188
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
disorders of pigmentation
Primary outcomes
1
Description
Repigmentation rate after treatment
Timepoint
Every 2weeks during 4 months
Method of measurement
Observtion
Secondary outcomes
1
Description
Diameter reduction
Timepoint
every 2 weeks during 4 months
Method of measurement
Evaluation of diameter with precise measurement
Intervention groups
1
Description
Intervention lesion: topical formulation of hydroalcoholic extract from fumaria officinalis in three different percents for one symmetric section of the patches, three times a day, and follow up every 2 weeks for 4 months.
Category
Treatment - Drugs
2
Description
Control lesion: use the none of topical treatments on the other side of the symmetric section of patches.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj daie's Dermatology Clinic in Kermanshah
Full name of responsible person
Dr. Ali Ebrahimi
Street address
Golestan Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services
Full name of responsible person
Dr Farid Najafi
Street address
Kermanshah University Of Medical Sciences, Beheshti blv, kermanshah, iran
City
Kermanshah
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, Kermanshah University Of Medical Sciences and Health Services