Investigating the safety and effectiveness of the endolift method in the treatment of primary axillary hyperhidrosis
Design
This study is conducted as a pilot study on 10 patients with primary axillary hyperhidrosis. The parallel study is a randomized blind.
Settings and conduct
This project is carried out at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Age over 20 years, increased underarm sweating if the sweat spot determined by the iodine starch test is more than 5 cm, hyperhidrosis is stable for more than 6 months.
Intervention groups
Intervention group: The patient will receive an endolift session in the armpit area. Control group: the patient will not receive any treatment.
Main outcome variables
Armpit sweating, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N43
Registration date:2024-06-15, 1403/03/26
Registration timing:prospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and effectiveness of the endolift method in the treatment of primary axillary hyperhidrosis
Public title
Investigating the endolift method in the treatment of primary axillary hyperhidrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years
Increased underarm sweating if the sweat spot determined by the iodine starch test is more than 5 cm
Persistence of hyperhidrosis for more than 6 months
Exclusion criteria:
Using drugs that affect the amount of sweating, such as cholinergic, adrenergic, antidepressant, and antipsychotic drugs.
Presence of secondary cause of sweating such as infection, malignancy and neurological disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are entered into the treatment groups based on computer random selection with a ratio of 1 to 1. From a box with 60 sealed envelopes, one envelope is selected for each patient, which contains code A or B. (A → the first method and B → the second method)
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst will not know the type of treatment performed in the patient's armpit.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of medical school - Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.052
Health conditions studied
1
Description of health condition studied
Increased armpit sweating
ICD-10 code
R61.0
ICD-10 code description
Localized hyperhidrosis
Primary outcomes
1
Description
Underarm sweat rate
Timepoint
The beginning of the study and 6 months after the end of the study
Method of measurement
Using Iodine starch test
Secondary outcomes
1
Description
Side effects
Timepoint
One week after endolift
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: The patient will receive an endolift session in the armpit area.
Category
Treatment - Other
2
Description
Control group: The patient will not receive any treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@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
Not applicable
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