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Safety and effectiveness assessment of Dermavisc deep, injectable gel for nasolabial folds correction

Protocol summary

Study aim
Safety and effectiveness assessment of Dermavisc deep, injectable gel for nasolabial folds correction
Design
Phase II, before after clinical study
Settings and conduct
The study will be conducted in Center for research and training in skin diseases and leprosy. Before intervention face photography will be taken from participants using digital camera and Visioface camera for determination the severity of nasolabial folds, according to Allergan scale. Skin ultrasound also will performed on nasolabial folds. One intradermal injection with Dermavisc deep will be performed on each nasolabial fold. The assessment will be repeated right after intervention and 2 weeks, 3 and 9 months later. Subjects’ satisfaction and adverse effect will be recorded in each follow up visit.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 -65 years old men and women, Moderate to severe nasolabial folds based on Allergan criteria, The opportunity to accompany the visit programs and study process, Signing the infirmed consent form and agree to a 9-month follow-up Exclusion criteria: Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment, Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 month prior to study entry,
Intervention groups
Intervention group: one injection with 1-2 cc Dermavisc deep injectable gel in each nasolabial fold.The product is a sterile, biodegradable, viscoelastic, transparent, isotonic and homogenized gel implant. This gel consists of transverse hyaluronic acid connections obtained from Streptococcus equi bacteria and formulated in physiological buffer with a concentration of 20 mg/ml .
Main outcome variables
Severity of nasolabial folds

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161207031288N12
Registration date: 2022-05-22, 1401/03/01
Registration timing: registered_while_recruiting

Last update: 2022-05-22, 1401/03/01
Update count: 0
Registration date
2022-05-22, 1401/03/01
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and effectiveness assessment of Dermavisc deep, injectable gel for nasolabial folds correction
Public title
Safety and effectiveness assessment of Dermavisc deep
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 -65 years old men and women Moderate to severe nasolabial folds based on Allergan criteria The opportunity to accompany the visit programs and study process. Signing the infirmed consent form and agree to a 9-month follow-up
Exclusion criteria:
Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 month prior to study entry Planning to undergo any of these procedures at any time during the study
Age
From 18 years old to 65 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
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.045

Health conditions studied

1

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

Primary outcomes

1

Description
Severity of nasolabial folds
Timepoint
Before intervention and right after that and 2 weeks, 3 and 9 months later
Method of measurement
5 scale Allergan photonumeric grading

Secondary outcomes

1

Description
Depth, area and volume of nasolabial fold
Timepoint
Before intervention and right after that and 2 weeks, 3 and 9 months later
Method of measurement
Visioface camera

2

Description
Thickness and density of dermis
Timepoint
Before intervention and 2 weeks and 9 months later
Method of measurement
Skin ultrasound

Intervention groups

1

Description
Intervention group: one injection with 1-2 cc Dermavisc deep injectable gel in each nasolabial fold.The product is a sterile, biodegradable, viscoelastic, transparent, isotonic and homogenized gel implant. This gel consists of transverse hyaluronic acid connections obtained from Streptococcus equi bacteria and formulated in physiological buffer with a concentration of 20 mg/ml .
Category
Treatment - Drugs

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 St.,Naderi St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pouragen Company
Full name of responsible person
Hamidreza Beheshti
Street address
No. 22, 7th St., Khaled Islambouli St.
City
Tehran
Province
Tehran
Postal code
1513715116
Phone
+98 21 82711
Email
hamid.r.beheshti@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pouragen Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saman Ahmad Nasrollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
415, Taleghani St.,Naderi St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
samannasrol@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Proffesor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
415, Taleghani St.,Naderi St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
firozali@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
clinical traial
Street address
No. 415, Shahid Naderi Street, Taleqani Avnue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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