Protocol summary

Summary
The aim of current study is evaluation of the efficacy and safety of the subcision in the treatment of nasolabial folds. Participants are 10 patients between 30-60 years old with deep nasolabial folds that may cause problem for them cosmetically. Those with coagulative disorder or connective tissue disease and patients who have the history of filler injection during these five years will not allow participating in our study. The subcision needle will used in order to correct the nasolabial folds with the aim of inducing thrombosis in the nasolabial fold area that will filled the fold .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108097270N1
Registration date: 2012-01-27, 1390/11/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-01-27, 1390/11/07
Registrant information
Name
Reza Mahmoud Robati
Name of organization / entity
Skin research center, Shohad-e-Tajrish hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
robati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin research center, Shohada-e-Tajrish hosppital, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of efficacy and adverse effects of subcision in the correction of nasolabial fold
Public title
New way to treating the smile lines
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. age 30-60y; 2.deep nasolabial fold. Exclusion criteria:1.age under 30y; 2.lactation & pregnancy; 3.history of coagulopathy or use of anticouagulant drug; 4.active infection in facial zone; 5.inability to stay in the study; 6.history of collagen or elastin disorder and connective tissue disease; 7.history of facial skin cancer; 8.history of topical medication administration during 1 month before study except sunscreen; 9.history of cosmetic procedure during last year (laser,..); 10. history of filler injection in nasolabial fold during last 5 years.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
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
Skin research center ethics committe, Shahid Beheshti University of Medical Sciences
Street address
Shohada-e-Tajrish hospital, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-10-16, 1390/07/24
Ethics committee reference number
519/90

Health conditions studied

1

Description of health condition studied
improvement of nasolabial fold by subcision
ICD-10 code
Z41.9
ICD-10 code description
Procedure for purposes other than remedying health state, unspecified

Primary outcomes

1

Description
nasolabial fold
Timepoint
before treatment,1 w, 1 m and 6 m after treatment
Method of measurement
photograph,reviscometer

Secondary outcomes

1

Description
bleeding
Timepoint
immediately after treatment and the day after
Method of measurement
observation

2

Description
ecchymosis
Timepoint
2 hours ,1 day and 1 week after treatment
Method of measurement
observation

3

Description
infection
Timepoint
1 w after treatment
Method of measurement
physical exam

Intervention groups

1

Description
At first, the desired area is marked and local anesthesia is undergone using lidocain 1%. The subcision needle penetrates the skin from the margin of the nasolabial fold while its sharp edge is upward. The needle will be rotated till its tip become parallel to the dermoepidermal junction. The necessary movement will be done for releasing the fibrotic band .
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e-Tajrish hospital
Full name of responsible person
Dr. Reza Robati
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin research center, Shohada-e-Tajrish hospital
Full name of responsible person
Dr. Parviz Toosi
Street address
Shohada-eTajrish hospital, Shahrdari St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin research center, Shohada-e-Tajrish hospital
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
Skin Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Mahmoud Robati
Position
associate professor/M.D
Other areas of specialty/work
Street address
Skin Research Center, Shohada-e-Tajrish hospital, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
robati@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Mahmoud Robati
Position
associate proffesor/M.D
Other areas of specialty/work
Street address
Skin Research Center, Shohada-e-Tajrish hospital, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
rezarobati@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact

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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