Evaluating the Safety and Efficacy of highly viscous 33mg/ml Hyaluronic Acid volumiting filler in the Treatment of Facial Wrinkles
Design
Quasi-experimental clinical trial without control group
Settings and conduct
Azad University hospitals Tehran Medical Branch
Participants/Inclusion and exclusion criteria
Inclusion Criteria :Facial Wrinkles;Exclusion Criteria :Use of other Treatment in past 3 months
Intervention groups
Patients with Facial Wrinkles
Main outcome variables
Score of Before Treatment ; score of 6 months after Treatment ; Score of 12 months after Treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180228038905N1
Registration date:2018-03-19, 1396/12/28
Registration timing:retrospective
Last update:2018-03-19, 1396/12/28
Update count:0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Setareh Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8878 8919
Email address
s_tehrani@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Evaluating the Safety and Efficacy of highly viscous 33mg/ml Hyaluronic Acid volumiting filler in the treatment of facial wrinkles
Public title
Effect of Hyaluronic Acid in Wrinkles Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Facial Wrinkles
Exclusion criteria:
Use of other treatments in past 3 months
Patients with Neuromuscular junction disorder
Active Infection near the site of Injection
Allergy or Hypersensitivity to Hyaluronic Acid
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
86
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 Islamic Azad University of Medical Sciences Tehran branch
Street address
Islamic Azad University , Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.IAU.TMU.REC.1396.121
Health conditions studied
1
Description of health condition studied
Facial Wrinkles
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of Facial Wrinkles
Timepoint
Before injection , 6 & 12 months after injection
Method of measurement
Inspection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The product we used in this study was Variofil with the concentration of 33 mg/ml Hyaluronic Acid , The intensity of Facial Wrinkles determined the usage dose , we injected single dose & 2 weeks after injection if it was necessary , It is Injectable Filler , This Filler is product by a German company ADODERM GmbH
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Setareh Tehrani
Street address
Amiralmomenin Hospital, Shir Mohammadi St., Nazi Abad Town
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 5534 6262
Email
info@amhos.ir
2
Recruitment center
Name of recruitment center
Qods clinic
Full name of responsible person
Setareh Tehrani
Street address
Ghods Clinic, Ivanaki Ave., sixth phase, Qods Town
City
Tehran
Province
Tehran
Postal code
1469744971
Phone
+98 21 8807 8388
Email
Tehrani249@yahoo.com
3
Recruitment center
Name of recruitment center
Javaheri Hospital
Full name of responsible person
Setareh Tehrani
Street address
Javaheri Hospital, Khaghani St., shariati St.
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2261 8524
Email
Tehrani249@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Nadia Sharifi
Street address
Islamic Azad University Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Setareh Tehrani
Position
Assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Islamic Azad University Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 212206660
Email
s_tehrani@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Setare Tehrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Islamic Azad University Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
193951459
Phone
+98 21 2200 6660
Email
s_tehrani@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Setareh Tehrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Islamic Azad University Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
193951459
Phone
+98 21 2200 6660
Email
s_tehrani@iautmu.ac.ir
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
We share only part of information iclude of concentration of drug that is use, site of injection , efficacy, and side effects
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers of Universities and scientific institutes
Under which criteria data/document could be used
In order to improve current treatment procedure
From where data/document is obtainable
Contact with corespondent: Dr Setareh Tehrani email: s_tehrani@iautmu.ac.ir tel: 00982122006660 Address: Islamic Azad University Medical Science Branch, Khaghani St., Shariati St, Tehran Postal Code: 193951495
What processes are involved for a request to access data/document
Send written request to corespondent email. It takes almost two weeks to respond