Osmidrosis is perspiration odor in the area of the axilla. There are several different treatment options for osmidrosis. Recently, percutaneous ethanol injection has been shown to be effective for the treatment of osmidrosis. The aim of this study was to evaluate the clinical effectiveness and safety of percutaneous ethanol injection for the treatment osmidrosis. Design: single-blind, case-control comparative clinical trial between Percutaneous Ethanol Injection's efficacy with percutaneous injection of saline as placebo. Participants including criteria: 1) Having the complaint of osmidrosis. 2) Age between 12-35 years old. 3) Both genders. Setting and conduct: 60 patients with osmidrosis selected, case group with 30 patients and control group with 30 patients. In case group after local anesthesia, 90% ethanol was injected into the subcutaneous layer (near the interface of the dermis, where the sweat glands are located) using a 2.5 mL syringe with a 30 G needle, it was easily visible underneath the skin. The average amount of ethanol injected per side was 8.9 mL. In control group after local anesthesia, saline was injected into the subcutaneous layer near the interface of the dermis. Clinical improvement evaluated using the osmidrosis, starch-iodine test, visual analog scale (VAS). Biopsy will be examined from a patient before and after treatment. Adverse reactions of the treatments were recorded at every follow-up visit. Main outcome measured at 10 months after the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122420426N1
Registration date:2015-04-09, 1394/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-09, 1394/01/20
Registrant information
Name
Masoom Shahbazi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 9683
Email address
masoom_shahbazi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical effect of percutaneous ethanol injection in the treatment of osmidrosis
Public title
Osmidrosis treatment with percutaneous ethanol injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the complaint osmidrosis; age between 12-35 years old; both genders; willingness for participation in the study and signing the consent form. Exclusion criteria: pregnant or breast-feeding women; active infection at the axilla.
Age
From 12 years old to 35 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jarib Avenue , Isfahan
City
Isfahan
Postal code
Approval date
2013-04-16, 1392/01/27
Ethics committee reference number
393205
Health conditions studied
1
Description of health condition studied
Osmidrosis
ICD-10 code
L75
ICD-10 code description
Apocrine sweat disorders
Primary outcomes
1
Description
osmidrosis
Timepoint
after ten months of injection
Method of measurement
starch-iodine test , visual analog scale(VAS)
Secondary outcomes
1
Description
Patients satisfaction
Timepoint
At base line – at the end of the study
Method of measurement
visual analog scale (VAS)
Intervention groups
1
Description
30 Patients ranged in age from 12 to 35 years in case group were treated with percutaneous ethanol injection well. The injection procedure was carried out in an outpatient basis. Patients were placed in a supine position
with their arms abducted about 100 degrees to
expose the axilla. Marks were made around the
location of the axillary hair-bearing area, where the apocrine glands are located. When we first started
using the technique, grid-pattern markings were used
to reduce the chances of uneven distribution of the
ethanol.
Category
Treatment - Other
2
Description
30 Patients ranged in age from 12 to 35 year in control group as placebo were treated with percutaneous saline injection well. The injection procedure was carried out in an outpatientbasis. Patients were placed in a supine positionwith their arms abducted about 100 degrees toexpose the axilla. Marks were made around thelocation of the axillary hair-bearing area, where the apocrine glands are located. When we first startedusing the technique, grid-pattern markings were usedto reduce the chances of uneven distribution of thesaline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Masoom Shahbazi
Street address
Al Zahra Hospita, Soffeh Blvd.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor foer research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Ebrahim Esfandiari
Street address
Deputy of Research of Isfahan University of Medical Sciences , Hezar Jerib Avenue , Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor foer research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr. Masoom Shahbazi
Position
MD, assistant of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences .
City
Isfahan
Postal code
Phone
+98 31 3626 9683
Fax
Email
masoom_shahbazi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr. Ali Asilian
Position
Professor of dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences .
City
Isfahan
Postal code
Phone
+98 31 3665 5555
Fax
Email
asilian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin Diseases and leishmaniasis research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Full name of responsible person
Dr. Masoom Shahbazi
Position
MD, assistant of dermatology
Other areas of specialty/work
Street address
Department of dermatology,Al-Zahra Hospital ,Soffeh Blvd
City
Isfahan
Postal code
Phone
+98 31 3626 9683
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)