Comparison of efficacy of combined microdermabration and topical Bimatoprost with topical Bimatoprost alone in vitiligo patients refered to Afzalipur Hospital in Kerman
Comparison of efficacy of combined microdermabration and topical Bimatoprost with topical Bimatoprost alone in vitiligo patients refered to Afzalipur Hospital in Kerman
Design
doubled-blind clinical trial with control group and parallel group
Settings and conduct
this is a double-blind clinical trial.20patients with vitiligo and age between 5to18years attending Afzalipour hospital in Kerman enrolled the study .two nearly symmetric lesions choose and one of them treat with combination of microdermabration and topical Bimatoprost and another with topical Bimatoprost alone.
Participants/Inclusion and exclusion criteria
inclusion criteria is age between 5to18 years
exclusion criteria: segmental vitiligo, received treatment in last 3months ago ,pregnancy and lactation ,history of hypertension and asthma, allergy to drug's components
Intervention groups
to case group: combination of microdermabration and topical Bimatoprost and to control group:topical Bimatoprost alone
Main outcome variables
repigmentation percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220129053866N1
Registration date:2022-10-02, 1401/07/10
Registration timing:registered_while_recruiting
Last update:2022-10-02, 1401/07/10
Update count:0
Registration date
2022-10-02, 1401/07/10
Registrant information
Name
Sare Asna ashari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3243 4640
Email address
amirasna25@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of combined microdermabration and topical Bimatoprost with topical Bimatoprost alone in vitiligo patients refered to Afzalipur Hospital in Kerman
Public title
evaluating efficacy of combination therapy with microdermabration and topical Bimatoprost in comparison with topical Bimatoprost alone in vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with vitiligo with age
Exclusion criteria:
segmental vitiligo
received treatment in 3 past months
pregnancy
lactation
hypertension history
asthma history
allergy to drug components
Age
From 5 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
two nearly symmetric and similar lesions in each patient
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
this is a double-blind study for assessor(different from main physician) and analyzor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Kerman university of medical science
Street address
Ebne Sina Ave,Tahmasb abad Blvd
City
kerman
Province
Kerman
Postal code
761614111
Approval date
2022-01-24, 1400/11/04
Ethics committee reference number
IR.KMU.AH.REC.1400.263
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
repigmentation type
Timepoint
at base line and 1,2,3 and 6 months later
Method of measurement
physical exam
2
Description
repigmentation percentage
Timepoint
at base line and 1,2,3 and 6 months later
Method of measurement
physical exam
Secondary outcomes
1
Description
pruritis
Timepoint
at base line visit and 1,2,3 and 6 months later.
Method of measurement
physical exam and classification of severity to mild, moderate ,severe
2
Description
scaling
Timepoint
at base line visit and 1,2,3 and 6 months later.
Method of measurement
physical exam and classification of severity to mild, moderate ,severe
3
Description
erythema
Timepoint
at base line visit and 1,2,3 and 6 months later.
Method of measurement
physical exam and classification of severity to mild, moderate ,severe
Intervention groups
1
Description
Intervention group: treatment with topical Bimatoprost (exilia 0.03%,inoclon company)(two times in day) and microderm abrasion (every two weeks)
Category
Treatment - Drugs
2
Description
Control group: treatment with topical Bimatoprost (two times in day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Rezvan Amiri
Street address
Imam high way,Kerman
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
rezvanamiri1358@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
abbas pardakhty
Street address
Ebne sina Avenue Jahad Blvd
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Amiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour hospital,Imam high way
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8326
Email
rezvanamiri1358@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Amiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour hospital,Imam high way
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
rezvanamiri1358@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvanamiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour hospital,Imam high way
City
kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
Rezvanamiri1358@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available