Evaluation of therapeutic efficacy of Endo Radiofrequency in patients with axillary hidradenitis suppurativa
Design
In this interventional study, 18patients with hidradenitis suppurativa in the axilla are included in the study. The axillary hidradenitis suppurativa is treated with endo RF.The study is an observational comparison before and after treatment.
Settings and conduct
This study was performed on 18 patients with hidradenitis suppurativa of the axilla undergoing a session of treatment with endo-RF device, who entered the cysts with subsection cannula and with Power 90 and until the required heat by radio frequency (RF) waves. To destroy the cyst, it is transferred to the cyst and heated on the surface of the skin. This radiation continues and the cysts are destroyed.
Patients' satisfaction, side effects and tolerability of treatment will be assessed by a questionnaire and the extent of improvement will be assessed by a physician using hidradenitis suppurativa grading scoring and photography with a camera, before treatment and 3 months after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The diagnosis of hidradenitis suppurative is based on the diagnosis of a dermatologist, the absence of collagen and vascular patients, no pregnancy and lactation, patients' satisfaction with the study and age less than 65 years and more than 18 years.
Exclusion criteria: the presence of lesions and skin diseases such as skin cancer, skin infections, pregnancy and lactation and patient dissatisfaction.
Intervention groups
In this study, the intervention is endo RF and the intervention group is people aged 18 to 65 years with hidradenitis suppurativa in the axilla who referred to the dermatology clinic of Hazrat Rasoul Akram Hospital.
Main outcome variables
Qualitative and quantitative severity of hidradenitis suppurative lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140624018210N12
Registration date:2022-04-23, 1401/02/03
Registration timing:retrospective
Last update:2022-04-23, 1401/02/03
Update count:0
Registration date
2022-04-23, 1401/02/03
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-30, 1401/01/10
Expected recruitment end date
2022-04-14, 1401/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic efficacy of endo Radiofrequency in patients with axillary hidradenitis suppurativa
Public title
Endo RF in axillary hydradenitis suppurativa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of suppurative hydradenitis based on the diagnosis of a dermatologist
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hazrat Rasoul Akram Hospital ., Maziar Mansoori Street ., Sattar Khan Street ; Tehran; Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2022-03-19, 1400/12/28
Ethics committee reference number
R.IUMS.FMD.REC.1401.005
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
Qualitative severity of hidradenitis suppurativa
Timepoint
At the beginning of the study and three months later
Method of measurement
Photography and objective observation
Secondary outcomes
1
Description
hydradenitis suppurative severity score
Timepoint
At the beginning of the study and three months later
Method of measurement
based on *Hidradenitis Suppurativa Physician'sGlobal Assessment Scale*
Intervention groups
1
Description
This study will be performed as an interventional study on 18 patients aged 18 to 65 years with hidradenitis suppurativa of the axilla who referred to the dermatology clinic of Hazrat Rasool Akram Hospital during 1401. Hidradenitis suppurativa of the axilla undergoes a session of endo RF (Aphrodite) treatment by entering the cysts with a subduction cannula with an endo RF (Aphrodite) device and with 90 Power and until the required heat by radio frequency waves ( RF) To destroy the cyst, it is transferred to the cyst and heated on the surface of the skin. This radiation continues and the cysts are destroyed. In this study, the demographic and clinical characteristics of the patient are assessed by a questionnaire before starting treatment and patient satisfaction, side effects and tolerability of the treatment are assessed by a questionnaire 3 months after each treatment session. hidradenitis suppurativa grading will be done before each treatment session and 3 months after each treatment session and photography with a normal camera, before each treatment session and 3 months after each treatment session.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat raasbol akram hospital
Full name of responsible person
Elham Behrangi
Street address
Hazrat raasbol akram hospital ; Maziar Mansoori street ; Sattar khan street; Tehran ; Iran