Evaluating of safety and efficacy of Stylux Voluma dermal filler (Novajen Daru CO) for correction of moderate to severe nasolabial folds”
Design
The clinical trial study is a phase 2, single group, before -after study. sample size is 30. The study is not randomized.
Settings and conduct
The study will be conducted in Center for research and training in skin diseases and leprosy,Tehran University of Medical Sciences. 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 perform on nasolabial folds. One intradermal injection with Stylux Voluma will be performed on each nasolabial fold. The assessment will be repeated 2 weeks, 3 and 6 months after intervention. Subjects’ satisfaction and adverse effect will be recorded in each follow up visit.
Participants/Inclusion and exclusion criteria
18 -65 years old men and women, with moderate to severe nasolabial folds, without any cosmetic facial procedures during last 3 months, with no allergy to gram positive bacteria protein, gel ingredients and not auto immune or immune deficiency diseases. No pregnant and lactating
Intervention groups
One injection with 1-2 cc Stylux Voluma dermal filler made by Novajen Daru CO injectable gel in each nasolabial fold.
Main outcome variables
Severity of nasolabial folds according to Allergan grading
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N32
Registration date:2024-04-08, 1403/01/20
Registration timing:prospective
Last update:2024-04-08, 1403/01/20
Update count:0
Registration date
2024-04-08, 1403/01/20
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
2024-04-20, 1403/02/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of safety and efficacy of Stylux Voluma dermal filler (Novajen Daru CO) for correction of moderate to severe nasolabial folds”
Public title
Evaluating of safety and efficacy of Stylux Voluma dermal filler
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 informed consent form and agree to a 6-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 months prior to study entry
Planning to undergo any of these procedures at any time during the study.
Age
From 21 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 The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.191
Health conditions studied
1
Description of health condition studied
Nasolabial folds
ICD-10 code
R23.4
ICD-10 code description
Changes in skin texture
Primary outcomes
1
Description
Severity of nasolabial folds
Timepoint
Before intervention and 2 weeks later
Method of measurement
5 scale Allergan photo numeric grading
Secondary outcomes
1
Description
Depth, area and volume of nasolabial fold
Timepoint
Before intervention, 2 weeks, 3 and 6 months after intervention
Method of measurement
Visioface camera
2
Description
Thickness and density of dermis
Timepoint
Before intervention, 2 weeks and 6 months after intervention
Method of measurement
Skin ultrasound
Intervention groups
1
Description
Intervention group: One injection with 1-2 cc Stylux Voluma dermal filler made by Novajen Daru CO injectable gel in each nasolabial fold. Stylux Voluma is a sterile physiological solution, without fever microbial agent. The active ingredient of this product is stabilized sodium hyaluronic acid with non-animal origin.
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