1. Home
  2. Approved trials
  3. » فارسی

Comparative evaluation of iontophoresis with aluminum chloride hexahydrate gel versus iontophoresis with Tap water in people with primary palmar hyperhidrosis

Protocol summary

Study aim
Comparative evaluation of effectiveness and persistence of iontophoresis with aluminum chloride hexahydrate gel versus iontophoresis with Tap water in people with primary palmar hyperhidrosis
Design
Two arm parallel groups randomized trial
Settings and conduct
This study will be done in Shahid Beheshti Rehabilitation clinic. Iontophoresis with ACH gel will applied to the first group (n=16) and Iontophoresis with tap water will used for the second group (n=16). Sweating rate before and after the iontophoresis will measured with gravimetry test and QOL will measured with DLQI, 3days, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks and 6 months after the treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria : age 18-40, BMI 17-30, the presence of focal, visible sweating for at least 6 months without any obvious cause, besides the presence of at least two of the following characteristics: Bilateral and relatively symmetrical sweating, frequency of at least one episode per week, impairment of daily activities of the patient, age of onset less than 25 years, a positive family history and cessation of focal sweating during sleep. Having HDSS grade 2 or 3. Exclusion criteria : having pacemaker or substantial metal implants located in electrical current path, being pregnant, suffering from systemic disease leading to hyperhidrosis and any central or peripheral nervous system diseases.SSR (sympathetic skin response) greater than normal or absent SSR
Intervention groups
The first group (n=16) will receive iontophoresis with ACH gel. For the second group (n=16), iontophoresis will perform with tap water. Iontophoresis will applied to the patient’s dominant (right) hand. An iontophoresis stimulator (ActivaDose, iontophoresis delivery unit, Serial Number 12080971) with an intensity of 2 mA for 30 min will be used
Main outcome variables
1.sweating rate.2. DLQI questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160506027762N2
Registration date: 2020-02-09, 1398/11/20
Registration timing: retrospective

Last update: 2020-02-09, 1398/11/20
Update count: 0
Registration date
2020-02-09, 1398/11/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77263613
Email address
eghandali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of iontophoresis with aluminum chloride hexahydrate gel versus iontophoresis with Tap water in people with primary palmar hyperhidrosis
Public title
Effect of aluminum chloride hexahydrate gel iontophoresis on hyperhidrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-40, BMI 17-30.presence of focal, visible sweating for at least 6 months without any obvious cause, besides the presence of at least two of the following characteristics: Bilateral and relatively symmetrical sweating, frequency of at least one episode per week, impairment of daily activities of the patient, age of onset less than 25 years, a positive family history and cessation of focal sweating during sleep. HDSS 2 or 3 .
Exclusion criteria:
Having pacemaker or substantial metal implants located in electrical current path, being pregnant, suffering from systemic disease leading to hyperhidrosis and any central or peripheral nervous system diseases. SSR (sympathetic skin response) greater than normal or absent SSR
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of medical Sciences
Street address
Building number2, Shahid Beheshti University of Medical Sciences, Velenjack, next to Teleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-01-07, 1396/10/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.833

Health conditions studied

1

Description of health condition studied
Palmar hyperhidrosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sweating rate
Timepoint
before and 3 days, 1, 2, 3, 4, 8 weeks, and 24 weeks after the last treatment session
Method of measurement
Sweating rate with gravimetry test

2

Description
Quality of Life score in DLQI questionnaire
Timepoint
before and 3 days, 1, 2, 3, 4, 8 weeks, and 24 weeks after the last treatment session
Method of measurement
Quality of Life score with DLQI questionnaire

Secondary outcomes

1

Description
Sympathetic Skin Response (SSR)
Timepoint
Before and after the application of one session iontophoresis
Method of measurement
Using a Medelec Synergy Electromyography instrument

Intervention groups

1

Description
Intervention group:16 patients with Palmar hyperhidrosis will receive iontophoresis with aluminum chloride hexahydrate gel ( manufactured in department of pharmaceutical of Shahid Beheshti University of Medical Sciences)
Category
Rehabilitation

2

Description
Intervention group: 16 patients with Palmar hyperhidrosis will receive iontophoresis with tap water
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic Shahid Beheshti Rehabilitation School
Full name of responsible person
Seyed Majid Hosseini
Street address
School of Rehabilitation, Opposite to Bou Ali Hospital, Damavand Road, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Email
majidhosseini44@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Building number2, Shahid Beheshti University of Medical Sciences, Velenjack, next to Teleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
School of Rehabilitation, Shahid Beheshti University of medical Sciences
Full name of responsible person
Seyed Majid Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Opposite to Bou Ali Hospital, Damavand Road, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Email
majidhosseini44@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation, Shahid Beheshti University of medical Sciences
Full name of responsible person
Seyed Majid Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Opposite to Bou Ali Hospital, Damavand Road, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Email
majidhosseini44@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation, Shahid Beheshti University of medical Sciences
Full name of responsible person
Seyed Majid Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Opposite to Bou Ali Hospital, Damavand Road, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Email
majidhosseini44@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information and variables are shared
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To continue research and get acquainted with the method of work and It is only available to researchers working in academic and scientific institutions
From where data/document is obtainable
Seyed Majid Hosseini majidhosseini44@yahoo.com
What processes are involved for a request to access data/document
After the request is received by email as soon as the data reaches him
Comments
Loading...