Nasolabial folds. Changes in skin texture
Conditions
Interventions
Intervention group: One treatment session with 1-2 ml of injectable gel with MBI (X-Mild) brand in two nasolabial folds.MBI(X-Mild) is a syringe containing hyaluronic acid ready for injection, sterile
Sponsors
Mizan Behdasht Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 18-65 year 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: 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 Auto immune or immune deficiency diseases Allergy to gram positive bacteria protein, gel ingredients Pregnancy and Lactation
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 photo numeric 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 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