Skin aging.
Conditions
Interventions
Intervention group: one injection with 1-2 cc Nuxiwell injectable gel in each nasolabial fold. The product is 1cc prefilled sterilized syringe containing: 25 mg cross-linked Hyaluronic Acid gel(Odorle
Sponsors
Amitis Nik Darou co.
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 6-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 intervention and 2, 12 and 24 weeks 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 intervention and 2, 12 and 24 weeks later. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention and right after intervention and 2, 12 and 24 weeks later. Method of measurement: Skin ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAniseh Samadi
Tehran University of Medical Sciences
Outcome results
None listed