Comparison of suction blister and micro punch grafting methods in the treatment of patients with stable vitiligo
Design
Double-blind clinical trial work with random assignment
Settings and conduct
2019-2020/ Alzahra Hospital Dermatology Clinic
Participants/Inclusion and exclusion criteria
1- The age of patients should be between 13 and 65 years
2. Patients must give informed consent
3. Patients should be willing to cooperate during the study and follow-up period
Intervention groups
Punch graft- suction blister
Main outcome variables
Improvement-Complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210206050270N1
Registration date:2021-07-21, 1400/04/30
Registration timing:retrospective
Last update:2021-07-21, 1400/04/30
Update count:0
Registration date
2021-07-21, 1400/04/30
Registrant information
Name
Atefe Samimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3782 0132
Email address
atsamimi71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
2020-10-06, 1399/07/15
Actual recruitment end date
2020-10-21, 1399/07/30
Trial completion date
2021-05-20, 1400/02/30
Scientific title
Comparison of suction blister and micro punch grafting methods in the treatment of patients with stable vitiligo
Public title
Comparison of suction blister and micro punch grafting methods in the treatment of patients with stable vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with persistent vitiligo are resistant to medical treatment, ie they have not had a new lesion in the past year and their previous lesions have not become larger.
Patients should be between 13 and 65 years old
Patients must give informed consent
Patients should be willing to cooperate during the study and follow-up period.
Exclusion criteria:
Patients with immunodeficiency
atients with bleeding disorders
Patients being treated for other illnesses
Age
From 13 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, 2 patches of vitiligo are selected in similar parts of the body or in symmetrical parts of the body
Actual sample size reached:
31
Randomization (investigator's opinion)
Randomized
Randomization description
In each patient, 2 vitiligo patches are selected in similar parts of the body or in symmetrical parts of the body. Then one of the patches is called A and the other B is called by the third person not involved in the study without the patient and the reader.
The patch for each intervention will be selected using the online software Random.org so that the two letters A and B are entered in the software, then the letter that the software shows in the first row will indicate the patch that The suction blister on it and the second letter displayed will indicate the patch on which the micro punch grafting will be performed.
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
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 186, Farhang Complex, 6th Ave., Farhang Blvd.
City
Isfahan
Province
Isfehan
Postal code
8178644802
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.MUI.MED.REC.1399.573
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Having Complaints
Timepoint
2 and 4 months after treatment
Method of measurement
questionnaire- visual analog scale (VAS)
2
Description
Improvement Score
Timepoint
2 and 4 months after treatment
Method of measurement
questionnaire-visual analog scale (VAS)
3
Description
Satisfaction Score
Timepoint
2 and 4 months after treatment
Method of measurement
questionnaire -visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Punch graft 1) Sterilize the graft site 2) The site will be anesthetized with topical lidocaine.3) Harvesting 100-200 2 mm punches in one or more stages 4) Graft implantation with 1.5 punch at the lesion site 5) Dressing the graft site with Vaseline gas 6) Remove the dressing a week later
Category
Treatment - Devices
2
Description
Intervention group: suction blister 1) Blisters on healthy areas of the skin that cover areas of the body2) Sterilize the graft site3) The site will be anesthetized with topical lidocaine.4) A vesicle is then formed at the donor site using the device described by Gupta et al.5) At this stage, the vitiligo patch is prepared and the dermis is removed on it by a dermabrator at an average speed of 15,000 rpm until the bleeding spots related to the papillary dermis appear. The blister created is then placed on a glass slide separated by special scissors and carefully placed on the patch.6) The lesion is then bandaged.7) Remove the dressing a week later
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital Dermatology Clinic
Full name of responsible person
Atefe Samimi
Street address
Isfahan university of medical science, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
atsamimi71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
atsamimi71@gmail.com
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, Isfahan University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of medical sciences, Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
international@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
Esfahan University of Medical Sciences
Full name of responsible person
Atefe Samimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.186, Farhang Complex, 6th Ave, Shafagh Blv,
City
Esfahan
Province
Isfehan
Postal code
685311654
Phone
+98 31 3782 0132
Fax
Email
atsamimi71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefe Samimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.186, Farhang Complex, 6th Ave, Shafagh Blv,
City
Esfahan
Province
Isfehan
Postal code
8565121654
Phone
+98 31 3782 0132
Fax
Email
atsamimi71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefe Samimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.186, Farhang Complex, 6th Ave, Shafagh Blv,
City
Esfahan
Province
Isfehan
Postal code
658511654
Phone
+98 31 3782 0132
Fax
Email
atsamimi71@gmail.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available