To evaluate the safety and efficacy of High-Intensity Focused Ultrasound (HIFU) (Anika device) in skin rejuvenation
Design
Single group, phase 2, before -after clinical study. sample size is 30.
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. Treatment will be done using Anika HIFU device in a session for 45 minuets. skin photography and measurement of skin biophysical parameters including skin elasticity, area and volume of wrinkles as well as ultrasound parameters will be performed before treatment, as well as 3 and 6 months later.
Participants/Inclusion and exclusion criteria
General healthy women or men aged 30 to 60 who tend to do facial anti ageing and signed the consent form for participation in the study
Intervention groups
Intervention group: One 45 minute treatment session on lower face , using Cartridges 3 and 4.5 mm of Anika HIFU device
Main outcome variables
changing in facial skin wrinkle using global aesthetic improvement scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N5
Registration date:2020-03-11, 1398/12/21
Registration timing:retrospective
Last update:2020-03-11, 1398/12/21
Update count:0
Registration date
2020-03-11, 1398/12/21
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
2019-05-22, 1398/03/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2020-01-13, 1398/10/23
Trial completion date
2020-03-20, 1399/01/01
Scientific title
To evaluate the safety and efficacy of High-Intensity Focused Ultrasound (HIFU) of Anika brand in skin rejuvenation
Public title
Anti aging efficacy of HIFU therapy using Anika device
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health
People who tend to do facial rejuvenation
Signing the consent form for participation in the study
Exclusion criteria:
History of skin tightening procedure within the past year
History of Botox injection in the lower face within the past 6 months
Presence of any active systemic or topical skin diseases which may affected wound healing
Presence of a metal stent or implant in the facial area
Active smoker in last 2 years
Pregnancy or lactating
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
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
2019-05-07, 1398/02/17
Ethics committee reference number
IR.TUMS.VCR.REC.1398.115
Health conditions studied
1
Description of health condition studied
Skin ageing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changing in facial skin wrinkle using global aesthetic improvement scale
Timepoint
3 and 6 months after intervention
Method of measurement
One independent dermatologist will perform clinical assessments in a blinded fashion by scoring every photograph according to the global aesthetic improvement scale .
2
Description
Skin elasticity
Timepoint
before intervention and 3 and 6 months later
Method of measurement
Cutometery
Secondary outcomes
1
Description
Skin thickness and density
Timepoint
before intervention and 3 and 6 months later
Method of measurement
Skin ultrasound
2
Description
Area and volume of nasolabial fold
Timepoint
before intervention and 3 and 6 months later
Method of measurement
VisioFace
Intervention groups
1
Description
Intervention group: One treatment session in lower face, using Cartridges 3 and 4.5 of HIFU device (Anika)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
center for research and training in skin diseases and leprosy