None listed
Conditions
Interventions
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 imp
Sponsors
Pouragen Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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.;Thickness and density of dermis. Timepoint: Before intervention and 2 weeks and 9 months later. Method of measurement: Skin ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaman Ahmad Nasrollahi
Tehran University of Medical Sciences
Outcome results
None listed