Nasolabial folds. Changes in skin texture
Conditions
Interventions
Intervention group: One injection with 1-2 cc Lunagel 2.5 dermal filler made by Nikan Teb Kimia CO injectable gel in each nasolabial fold. Lunagel 2.5 is a syringe containing 25 mg of hyaluronic acid
Sponsors
Nikan Teb Kimia 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 informed consent form and agree to a 6-month follow-up.
Exclusion criteria
Exclusion criteria: 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 Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment. 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 2 weeks later. Method of measurement: 5 scale Allergan photo numeric grading. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depth, area and volume of nasolabial fold. Timepoint: Before intervention, 2 weeks, 3 and 6 months after intervention. Method of measurement: Visioface camera.;Thickness and density of dermis. Timepoint: Before intervention, 2 weeks and 6 months after intervention. Method of measurement: Skin ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAniseh Samadi
Tehran University of Medical Sciences
Outcome results
None listed