Volume deficit of middle face area. Changes in skin texture
Conditions
Interventions
Intervention group: A treatment session with a maximum of 2 to 4 ml of Nuxiwell brand injectable gel made by Amitis Nik Darou Company.In the Zygomaticomalar area and, if the physician's discretion, in
Sponsors
Amitis Nik Darou Company
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women with 30 to 65 years old Moderate to very severe degree of volume reduction of middle face area, based on MFVDS(Allergan midface volume deficit scale) criteria Signing an informed consent form and agreed to follow up.
Exclusion criteria
Exclusion criteria: History of type 1 allergic reactions or anaphylaxis reaction Allergy or sensitivity to Ingredients of filler, lidocaine and proteins of microorganism producing HA (streptococcus) History of surgery or trauma in the injection area during the last six months Pregnant or lactating or planning to become pregnant in the near future while studying Use of antiplatelet drugs during 72 hours before treatment and anticoagulant drugs during 2 weeks before or during treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with improvement in midface volume deficit scale. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Allergan midface volume deficit scale (MFVDS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with improvement in midface volume deficit scale. Timepoint: Before intervention,12 and 24 weeks after intervention. Method of measurement: Allergan midface volume deficit scale (MFVDS).;Depth, area and volume of nasolabial fold. Timepoint: Before intervention and right after intervention and 4, 12 and 24 weeks later. Method of measurement: Visioface camera. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAniseh Samadi
Tehran University of Medical Sciences
Outcome results
None listed