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Evaluation of safety, efficacy and durability of PDO thread lift- EVE & NU series (product of Meditronic Dongjun CO) for facial rejuvenation: An open label, phase 2, before- after, clinical trial.

Protocol summary

Summary
Purpose of the study is the evaluation of safety, efficacy and durability of PDO thread lift- EVE & NU series for facial rejuvenation and face lift. It’s an open label, single group, phase 2, before- after, clinical study conducted on 20 male and female subjects 30-60 years old willing to lift the face or eyebrow or improve the nasolabial folds. The intervention will be performed in single session by a trained physician after preb and drep and local anesthesia with lidocaine. Follow up visits will be 3 and 7 days after intervention as well as1, 3 and 6 months later. Primary endpoint will be improvement assessment by independent dermatologist, based on photographs of the treated area, using the Physician’s global assessment score as a reference, at baseline, right after treatment, 1, 3, and 6 months after the treatment. Secondary end points will be Wrinkle analysis done by Visioface 6 months after the treatment and measurement of skin biophysical parameters at month 6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016120720514N6
Registration date: 2017-11-11, 1396/08/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-11, 1396/08/20
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
Aftab Forouzan Arya company
Expected recruitment start date
2017-07-04, 1396/04/13
Expected recruitment end date
2017-08-04, 1396/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety, efficacy and durability of PDO thread lift- EVE & NU series (product of Meditronic Dongjun CO) for facial rejuvenation: An open label, phase 2, before- after, clinical trial.
Public title
Evaluation of safety and efficacy of two types of thread lift for facial rejuvenation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male and female subjects 30-60 years old; willing to lift the face or eyebrow or improvement the nasolabial folds; providing written informed consent and attendance in follow up session. Exclusion criteria: History of any rejuvenated procedure during last years in face area; history of any Botulinum, laser, or intense pulsed light during last 6 month; history of Isotretinoin during last 3 month; collagen vascular disease; any systemic or topical disorders which interfere with process of wound healing; history of any implant in face area; severe cardiac disease or cardiac pacemaker; any active, chronic and recurrent infection; bleeding disorders, coagulopathy, any drugs affect bleeding time; susceptibility to keloids or scar formation; active smoker ( last 2 years); pregnancy/ breast feeding
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: 20
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
Tehran University of Medical Science
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
2017-05-14, 1396/02/24
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2293

Health conditions studied

1

Description of health condition studied
skin rejuvenation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
improvement assessment using the Physician’s global assessment score
Timepoint
before and 1,3,6 months after treatment
Method of measurement
based on pictures

Secondary outcomes

1

Description
skin hydration
Timepoint
before and after 1,3,6 months
Method of measurement
Corneometer® - Courage - Khazaka

2

Description
Trans epidermal water loss
Timepoint
before and after 1,3,6 months
Method of measurement
Tewameter® TM 300 - Courage - Khazaka

3

Description
depth, area and volume of wrinkle in intervention area
Timepoint
before and after 1,3,6 months
Method of measurement
VisioFace

Intervention groups

1

Description
single session inserting treated lift by a trained physician after preb and drep and local anesthesia with lidocaine
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Street address
415, Taleghani Avenue.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aftab Froozan Arya Organization
Full name of responsible person
Fariba Paslar
Street address
No 42, Nahid Alley, Mirzaye Shirazi St., Motahari St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aftab Froozan Arya Organization
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
MD and Researcher
Other areas of specialty/work
Street address
No. 415, Taleqani Ave.
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Fax
+98 21 8896 3804
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 St.
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
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
MD and Researcher
Other areas of specialty/work
Street address
No 415, Taleqani St.
City
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Fax
+98 21 8896 3804
Email
aniseh_samadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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