Safety and effectiveness of Alma plus laser device (diode laser device) to reduce unwanted hair in the legs area.
Design
Single group, phase 2, before -after clinical study. sample size is 30. The study is not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 30 healthy volunteers will be selected and enrolled in the study after signing consent form. Before intervention and at the end of 3 and 6 weeks later changing in both of legs hair count will be measured. 4 treatment sessions are performed once a month. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Men and women aged 18 to 50 years, Skin type 1-4, Signing the consent form for participation in the study
Exclusion criteria:
History of using any type of laser hair removal in the treatment area in the last 12 weeks, If the percentage of white hair in the area is more than 5%, Pregnancy or lactating
Intervention groups
4 treatment sessions using Alma plus laser device produced by Sadra Aqua Company on right and left legs with wavelength at 808 nm, pulse width of 2 to 100 milli seconds and fluence of 1 to 50 joules.
Main outcome variables
The rate of reduction of unwanted hairs of right and left legs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N19
Registration date:2023-01-30, 1401/11/10
Registration timing:prospective
Last update:2023-01-30, 1401/11/10
Update count:0
Registration date
2023-01-30, 1401/11/10
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
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and effectiveness of Alma plus laser device (diode laser device) to reduce unwanted hair in the legs area.
Public title
Safety and effectiveness of Alma plus laser device to reduce unwanted hair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 18 to 50 years
Skin type 1-4
Signing the consent form for participation in the study
Exclusion criteria:
History of using any type of laser hair removal in the treatment area in the last 12 weeks
If the percentage of white hair in the area is more than 5%
Pregnancy or lactating
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of medical school-Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.700
Health conditions studied
1
Description of health condition studied
unwanted hair
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of reduction of legs hairs in both sides
Timepoint
Before the intervention and 3 months after the last treatment session
Method of measurement
Trichoscopy By Fotofinder
Secondary outcomes
1
Description
Comparison of pain level in both sides
Timepoint
Right after each treatment
Method of measurement
Visual analog scale (VAS)
Intervention groups
1
Description
Intervention group: 4 treatment sessions using Alma plus laser device produced by Sadra Aqua Company on right and left legs with wavelength at 808 nm, pulse width of 2 to 100 milli seconds and fluence of 1 to 50 joules.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy