The purpose of this clinical study is to compare the efficacy and side effects of axilla hair reduction using ALX handpiece of MeDioStar and Cynosure devices. The subjects are people aged 18-50 and have not the history of any previous laser and regional electrolysis on study areas. The study is conducted on healthy males and females, willing to consent to participate in the study for axilla hair reduction. The sample size is 20 subjects. The intervention includes 4 treatment sessions on right and left axilla regions, using the ALX handpieces of and Cynosure device. Right or left axilla randomly selected to treat with MeDioStar device and the opposite axilla will be treated with Cynosure. Primary outcome is comparison of percentage of reduction of axilla hairs in right and left axilla, using before and after photos. The secondary outcomes are comparison of skin biophysical changes and pain level in both sides.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015010420514N2
Registration date:2016-10-30, 1395/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Institute for Medical Research Development (NIMAD)
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-22, 1395/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of axilla hair reduction using ALX handpiece of MeDioStar NeXTPRO and Cynosure devices.
Public title
Comparison of two different laser devices for axilla hair reduction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: males or females with age of 18 – 50 years old; skin types II – IV; the subject must be willing to consent to participate in the study.
Exclusion criteria: children and pregnant or lactating women; any previous laser; treatment to the study areas; regional electrolysis within 6 months of study entry; history of keloid scarring; hormonal dysfunction; active cutaneous infection within the treatment area; chronic sun exposure or tanning; photosensitivity; use of medication with androgenic effects; history of skin pigmentation disorders; cancerous and pre-cancerous lesions in the treatment area; haired nevi in the treatment area; tattoos in the area to be treated.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Right or left axilla randomly selected to treat with MeDioStar device and the opposite axilla will be treated with Cynosure.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Postal code
1417653761
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.TUMS.VCR.REC.1395.264
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of reduction of axilla hairs in both sides.
Timepoint
Before treatment and 3, 6 and 12 months after last treatment.
Method of measurement
Using before and after photos.
Secondary outcomes
1
Description
Comparison of skin biophysical changes in both sides.
Timepoint
Before treatment and 3, 6 and 12 months after last treatment.
Method of measurement
Related probes of MPA device, CK electronic, Germany.
2
Description
Comparison of pain level in both sides.
Timepoint
Right after each treatment.
Method of measurement
Visual analog scale (VAS)
Intervention groups
1
Description
Control group: 4 treatment session using Alex probe of Cynosure device.
Category
Treatment - Other
2
Description
Intervention group: 4 treatment session using Alex probe of Mediostar device.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dowlati Skin Clinic
Full name of responsible person
Dr. Aniseh Samadi
Street address
No 40, Daman Afshar street, Valiasr avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development (NIMAD)
Full name of responsible person
Reza Malekzadeh
Street address
Between Gharib and Eskandari Ave, Azadi Street.
City
Tehran
Grant name
Grant code / Reference number
943717
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development (NIMAD)
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
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Medical Doctor
Other areas of specialty/work
Street address
415, Taleghani Avenue.
City
Tehran
Postal code
1416613675
Phone
+98 21 8896 3804
Fax
Email
aniseh_samadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Dermatologist and professor of Tehran Univercity of Medical Sciences.
Other areas of specialty/work
Street address
No. 415, Taleqani Ave.
City
Tehran
Postal code
1416613675
Phone
+98 21 8896 3804
Fax
Email
firozali@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Medical Doctor
Other areas of specialty/work
Street address
No. 415, Taleqani Ave.
City
Tehran
Postal code
1416613675
Phone
+98 21 8896 3804
Fax
Email
aniseh_samadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)