Skin aging
Conditions
Interventions
This is a randomized, controlled, triple-blind clinical trial. Experimental group: 17 patients will be applied microfocused ultrasound (shots with 0.7 to 0.9J) followed by injection with 2 vials of po
Sponsors
Fernanda Almeida Nunes Castro
Angioderm Centro de Estética Ltda
Clinica Dermatológica Milide
Clinica Boro Seviços Médicos Ltda
Morais e Neuenschwander Medicina Integrada
Eligibility
Sex/Gender
Female
Age
35 Years to 50 Years
Inclusion criteria
Inclusion criteria: Healthy women, 35 and 50 years old, with mild to moderate facial laxity.
Exclusion criteria
Exclusion criteria: facial surgical scar; history of herpes simplex infection; active or systemic infection; non-steroidal anti-inflammatory drugs use; anticoagulants use; steroids use; heparin; vitamin K or E within the last 30 days prior to the study; pregnancy; breastfeeding; any clinical condition and or laboratory abnormality; previous aesthetic procedures with biostimulators or physical resources such as laser, radiofrequency and or ultrasound on the face in the last 3 years; injection of permanent materials in the face anytime
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in facial skin sagging by scale: improvement of at least 2 points after 6 months, and at least 1 point after 3 months according to the sagging scale;Adverse event ratio: calculated the relation of the number of participants who had any adverse event by the total number of participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of sagging in the upper third: the lift of the eyebrow, in mm, after 3 and/or 6 months compared to pre-procedure;Global aesthetic improvement: improved, much improved or very much improved of the GAIS scale after 3 and 6 months, compared to the pre-procedure evaluation, assessed by doctors and participants;Maintenance of Global aesthetic improvement at 6 months: maintanance of GAIS values between 3 and 6 months of GAIS assessed by doctors and participants ;Improvement of flaccidity (lifting effect): global improvement, in mm, of the lifting of the face ;Cumulative adverse event percentage curve plotted;Total adverse event rate: the ratio of the total number of adverse events reported by the total number of patients. ;Pain: analyzed by visual analogue scale (VAS) during the first 24 hours after procedure | — |
Countries
Brazil
Contacts
Public ContactFernanda Nunes
Angioderm Centro de Estética Ltda
Outcome results
None listed