Safety and efficacy assessment of Alexandrite laser device (model PG100)in axilla hair reduction
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 axillary hair count will be measured. 6 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
6 treatment session using Alex probe of PG100 device once a month
Main outcome variables
The rate of reduction of axilla hairs in both sides
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N15
Registration date:2021-11-23, 1400/09/02
Registration timing:registered_while_recruiting
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy assessment of Alexandrite laser device (model PG100)in axilla hair reduction
Public title
Safety and efficacy assessment of Alexandrite laser device in hair reduction
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 of 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
2021-04-28, 1400/02/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.100
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 axilla hairs in both sides
Timepoint
Before treatment and 3 and 6 months after last treatment.
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
6 treatment sessions using Alexandrite probe of PG100 device on right and left axilla, with fluence of 5 to 12 joules and pulse width of 20 to 40 mii seconds. Treatment sessions take 10 to 15 minutes with 4 weeks interval.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy