Primary Axillary Hyperhidrosis is excessive sweating in the area of the axilla. There are several different treatment options for Primary Axillary Hyperhidrosis. Recently, Fractionated Microneedle Radiofrequency devices have been shown to be effective for the treatment of primary axillary hyperhidrosis .The aim of this study was to evaluate the clinical effectiveness and safety of Fractionated Microneedle Radiofrequency for the treatment Primary Axillary Hyperhidrosis. Design: single-blind, sham-control right-left comparative clinical trial. Participants including criteria: 1) Having the complaint of Primary axillary hyperhidrosis and score 3 or 4 in Hyperhidrosis Disease Severity Scale (HDSS). 2) Age between 18-50 years 3) both genders. Setting and conduct: 25 participants with Primary axillary hyperhidrosis selected and he/she underwent FMR (INFINI TM; Lutronic, Goyang, Korea®) 3 sessions, at 3-week intervals on the left axilla. In right axilla (sham-control) the device was on standby mode. Clinical improvement evaluated using the Hyperhidrosis Disease Severity Scale (HDSS) , starch-iodine test ,Sweating intensity visual analog scale (VAS) . Patients Satisfaction was obtained using the Dermatology Life Quality Index (DLQI) and a 6-point scale. Adverse reactions of the treatments were recorded at every follow-up visit. Main outcome measured at 1 and 3 weeks after each session and 3 months after the last session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111915455N1
Registration date:2014-01-23, 1392/11/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-23, 1392/11/03
Registrant information
Name
Bahareh Abtahi-Naeini
Name of organization / entity
Skin Diseases and leishmaniasis research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Country
Iran (Islamic Republic of)
Phone
+98 31 1264 2901
Email address
bahareh.abtahi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Isfahan University of Medical Sciences .
Expected recruitment start date
2013-10-31, 1392/08/09
Expected recruitment end date
2013-11-30, 1392/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of Fractionated Microneedle Radiofrequency in the treatment of severe primary axillary hyperhidrosis
Public title
Treatment of axillary hyperhidrosis by Microneedle Radiofrequency.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the complaint Primary Axillary Hyperhidrosis and score 3 or 4 in Hyperhidrosis Disease Severity Scale (HDSS); Age between 18-50 years ; 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 ; taking anticholinergic drug ; heart pace-maker or cardiac defibrillator ; taken botulinum toxin injections in the axillae within the previous 6 months ; Patients who have propensity for keloid formation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sham-control right-left comparative clinical trial. Right axilla as a sham control
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences.
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2013-10-30, 1392/08/08
Ethics committee reference number
392507
Health conditions studied
1
Description of health condition studied
Axillary hyperhidrosis
ICD-10 code
R61.0
ICD-10 code description
Localized hyperhidrosis
Primary outcomes
1
Description
Severity of sweating
Timepoint
1 and 3 weeks after each session and 3 months after the last session.
1 and 3 weeks after each session and 3 months after the last session.
Method of measurement
Examination
2
Description
Quality of life
Timepoint
At base line – at the end of the study
Method of measurement
Dermatology Life Quality Index (DLQI)
3
Description
Pigmentation
Timepoint
1 and 3 weeks after each session and 3 months after the last session.
Method of measurement
Examination
4
Description
Compensatory hyperhidrosis
Timepoint
1 and 3 weeks after each session and 3 months after the last session.
Method of measurement
Ask the subjects
5
Description
Local reactions
Timepoint
1 and 3 weeks after each session and 3 months after the last session.
Method of measurement
Examination
Intervention groups
1
Description
The left axilla was treated with a total of 3 passes of Fractionated Microneedle Radiofrequency. The treatment parameters included :
The depth was at 2-3 mm; The energy level was at 6- 10 Jules; The Time was at 120- 180 m sec with a small range (±10%) of variation for energy and time.
Category
Treatment - Other
2
Description
The right axilla was treated with a total of 3 passes of Fractionated Microneedle Radiofrequency when the device was on standby mode (sham control).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Zahra hospital
Full name of responsible person
Dr bahareh Abtahi-Naeini
Street address
Department of Dermatology, Al-Zahra hospital, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
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 bahareh Abtahi-Naeini
Position
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 1264 2901
Fax
+98 26 69285
Email
bahareh.abtahi@yahoo.com
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 Farahnaz Fatemi Naeini
Position
Associate 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 1260 2950
Fax
Email
fatemi_farahnaz@yahoo.com
Web page address
www.med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Bahareh Abtahi-Naeini
Position
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 1264 2901
Fax
+98 26 69285
Email
bahareh.abtahi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)