Effects of Endo-Radifrequency (endo RF) treatment in skin lesions on one side of the body in patients with hidradenitis suppurativa and comparing it with the untreated side.
Determining the therapeutic effect of endo-radiofrequency in the improvement of skin lesions in patients with hidradenitis suppurativa
Design
A clinical trial with a control group, with parallel groups, assessor-blind, randomized, phase 2 on 15 patients. Random Allocation software is used for randomization of the lesions.
Settings and conduct
This study is conducted on patients with hidradenitis suppurativa who are referred to skin clinics of Shiraz University of Medical Sciences. Patients' lesions are randomly divided into two groups (right and left lesions). The plan is done in an outcome assessor-blinding
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with moderate to severe cases (Hurley Stage) of HS disease according to clinical evidence; having informed consent to participate in the study, and being over 18 years old. The study excludes patients who have an active infection at the procedure site. Patients who are allergic to anesthetics; those who have a cardiac pacemaker, and those who have metallic implants are also excluded. Pregnant or lactating women; patients with unilateral lesions; receiving anticoagulant and antiplatelet drugs; performing surgery at the procedure site; patients with an underlying autoimmune disease.
Intervention groups
Intervention group: We will use the endo-RF Aphrodite device for the procedure, setting its power to 50. After administering anesthesia, a needle penetrates the skin. We create the cannula and insert it parallel to the skin in the middermis and SQ areas. Simultaneously, we will fix the thermal camera on the lesion site, and the device operator will continuously monitor the camera's temperature to ensure it stays below 39 degrees for 20 minutes. Control group: No special action is taken for lesions in the control group (opposite side of the patient).
Main outcome variables
Patient's recovery rate using HiSCR Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N24
Registration date:2024-06-28, 1403/04/08
Registration timing:registered_while_recruiting
Last update:2024-06-28, 1403/04/08
Update count:0
Registration date
2024-06-28, 1403/04/08
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-18, 1403/03/29
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Endo-Radifrequency (endo RF) treatment in skin lesions on one side of the body in patients with hidradenitis suppurativa and comparing it with the untreated side.
Public title
Effects of Endo-Radifrequency (endo RF) treatment patients with hidradenitis suppurativa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe cases (Hurley Stage) of HS disease according to clinical evidence
Having Informed consent to participate in the study
Age above 18 years old
Exclusion criteria:
Patients with active infection at the procedure site
Patients allergic to anesthetics
Patients with a cardiac pacemaker
Patients with metallic implants
Pregnant and lactating women
Patients with unilateral lesions
Receiving anticoagulant and antiplatelet drugs
Performing surgery at the procedure site
Patients with underlying autoimmune disease, malignancy and immunodeficiency
Phobia about treatment with RF
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
One of the lesions on one side of the body will be selected as intervention and the lesion on the other side will be selected as control
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Allocation Software, consecutive permutation blocks with the size of 4 in each block are made and the lesions are divided into two groups A (right side) and B (left side). Dark-colored envelopes will be used to hide random allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, it is not possible to blind the patients, but the outcome assessor is different from the person performing the intervention, and the design will be conducted as outcome-assessor blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2023-08-26, 1402/06/04
Ethics committee reference number
IR.SUMS.MED.REC.1402.226
Health conditions studied
1
Description of health condition studied
Hidradenitis suppurativa
ICD-10 code
L73.2
ICD-10 code description
Hidradenitis suppurativa
Primary outcomes
1
Description
Assessing the recovery of lesions from the doctor's point of view
Timepoint
Start studying, the end of the second, fourth and eighth weeks
Method of measurement
Impression of improvement (CGI-I)
2
Description
Overall improvement rate from the patient's point of view
Timepoint
Start studying, the end of the second, fourth and eighth weeks
Method of measurement
Patient global impression of improvement(PGA)
3
Description
Assessment of recovery process
Timepoint
Start studying, the end of the second, fourth and eighth weeks
Method of measurement
Using HiSCR Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An alcohol spray and betadine will clean and sterilize the affected area before the procedure, and a local injection of a 2% lidocaine ampoule will provide anesthesia. We will use the endo-RF Aphrodite device for the procedure, setting its power to 50. We will use the appropriate cannula, which comes in three sizes, based on the location of the conflict and the size of the lesions. After administering anesthesia, a needle penetrates the skin. We create the cannula and insert it parallel to the skin in the middermis and SQ areas. We perform this procedure at three to five points in each location. Simultaneously, we will fix the thermal camera on the lesion site, and the device operator will continuously monitor the camera's temperature to ensure it stays below 39 degrees for 20 minutes. We also recommend using the ointment for 3-5 days, and prescribe oral cephalexin 500 mg every 6 hours for one week.
Category
Treatment - Surgery
2
Description
Control group: No special action is taken for lesions in the control group (opposite side of the patient).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348466114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashem Hashempur
Street address
Shiraz University of medical Sciences, Research vice, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7252
Email
Hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zahra Shiravani
Position
Dermatology Resident
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
shirvaniz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Saki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews.
From where data/document is obtainable
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
What processes are involved for a request to access data/document
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
Comments
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.