Comparison the effect of long-pulsed ND-YAG laser and aluminum chloride 20% in the treatment of axillary hyperhidrosis
Design
Two arm parallel group randomised non-blinded clinical trial.Randomisation was done using flip a coin method. In case of head, patients will be treated by laser and in case of tails, aluminum chloride will be given as treatment.
Settings and conduct
Fifteen (15) patients with axillary hyperhidrosis which have inclusion criteria and attending to Shohadaye-Tajrish Hospital will be selected.
Intervention group 1 will be treated with long pulsed ND-Yag with hair removal setting each month for 3 consecutive months. Intervention group 2 will be treated with aluminum chloride 20 % applying daily for 3 months. At the end of 3 months and 6 months after treatment area of hyperhydrosis will be indicated with iodine starch test and compared between 2 groups. In addition, treatment results will be assessed using global physician scale by comparing digital photos taken a tbaseline and at the end of the treatment. Scaling would be as:
mild improvement ( decrease in sweating by 0-25%);
Moderate improvement: (decrease in sweating by 25-50%);
Good improvement: (decrease in sweating by 50-70%);
Excellent improvement: (decrease in sweating by 75-100%).
Participants/Inclusion and exclusion criteria
Inclusion criteria:age older than 18 years;having axillary hyperhidrosis;
hyperhidrosis lasting for 6 months or more.
Non-inclusion criteria: using drugs which affect sweating such as anticholinergic; adernergic, antipshychotic ect; secondary cause of sweating such as infection; neurological disease, neoplasm
Intervention groups
Intervention group 1:individuals are treated with Aluminum chloride 20% daily for 3 months
Intervention group 2:individuals are treated with ND-Yag-laser with hair removal setting (frequency of 1 Hz, pulse of 30ms and energy of 30 J/Cm2) each month for 3 consecutive months
Main outcome variables
axillary sweating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190212042683N2
Registration date:2019-09-30, 1398/07/08
Registration timing:retrospective
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Tara Barat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2211 8152
Email address
barat_t@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of long-pulsed ND-YAG laser and aluminum chloride 20% in the treatment on axillary hyperhidrosis
Public title
The effect of long-pulsed ND-YAG laser on the treatment of axillary hyperhidrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years old
Having hyperhidrosis defined as sweating which stain axillary region more than 5 cm using Iodine starch test
hyperhidrosis lasting for 6 month or more
Exclusion criteria:
Using drugs which affect sweating such as anticholinergic, adernergic and antipshychotic drugs
second cause of sweating such as infection, neurological disease and malignancy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using flip the coin method
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.SBMU.SRC.REC.1397.018
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
Axillary sweating amount
Timepoint
base line, after treatment ( month 3) and 6 months after treatment
Method of measurement
Iodine starch test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Participants will be treated with Long pulsed ND-YAG laser with hair removal setting once a month
Category
Treatment - Devices
2
Description
Intervention group 2: Patients will be treated with aluminum chloride 20% daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mehdi gheisari
Street address
Shohadaye Tajrish Hospital, Shahrdari St, Tajrish Square, Tehran town
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St, Yaman St, Chamran highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tara Barat
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 26, Lame street, Koye Faraz ave, Saadatabad
City
Tehran
Province
Tehran
Postal code
1981959311
Phone
+98 21 2211 8152
Fax
Email
barat_t@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tara Barat
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Skin research center, Shohadaye Tajrish Educational Hospital, Shahrdari street, Qods square
City
Tehran
Province
Tehran
Postal code
1981959311
Phone
+98 21 2274 1507
Email
Dr_t_barat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tara Barat
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Skin research center, Shohadaye Tajrish Educational Hospital, Shahrdari street, Qods square
City
Tehran
Province
Tehran
Postal code
1981959311
Phone
+98 21 2274 1507
Email
Dr_t_barat@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
General information of participants such as age, sex and family history
When the data will become available and for how long
Six months after publication of article
To whom data/document is available
Researchers in academic institution
Under which criteria data/document could be used
For research purpose after sending an official request to skin research center of Shahid Beheshti University of Medical Sciences
From where data/document is obtainable
Mehdi Gheisari; sending Email to src@sbmu.ac.ir or call the telephone number 00982122741507
What processes are involved for a request to access data/document
Sending an official request to skin research center of Shahid Beheshti University of Medical Sciences