Skin Aging
Conditions
Interventions
This study will be an interventional, randomized, parallel, double-blind clinical trial with two groups and with a total target sample of 36 patients, 18 in each group. The sample size calculation wa
E02.565.280.945.399
Sponsors
Universidade Estadual de Montes Claros
Universidade Estadual de Montes Claros
Eligibility
Age
36 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients aged between 35 and 65 years; patients who show moderate signs of skin aging; both sexes
Exclusion criteria
Exclusion criteria: Patients with a history of photosensitivity will be excluded; tendency to form keloids; with dermatitis; active herpes infection at the procedure site; pregnant women; breastfeeding women; pacemaker holders; with decompensated chronic diseases; wearing metal prostheses in the area to be treated; with a history of heart disease; patients with a history of autoimmune diseases using isotretinoin; anticoagulants; with a history of previous aesthetic treatments in the area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study will be to assess the safety and efficacy of High Intensity Focused Ultrassound HIFU treatment. Efficacy will be measured by changes in biomechanical skin parameters, including elasticity and firmness, comparing pre- and post-treatment conditions. Safety will be assessed by the incidence and severity of adverse events or complications related to treatment, compared to the control group undergoing sham treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include analysis of the thickness of the dermis, epidermis and subcutaneous fat in the treated facial regions using high-frequency ultrasound to compare the results between the HIFU-treated group and the control group. In addition, changes in the clinical appearance of wrinkles will be assessed using the Wrinkle Severity Rating Scale and patient satisfaction with the aesthetic results, measured by standardized questionnaires. The inflammatory response and markers of cell regeneration and collagen will also be analyzed through biopsies and molecular tests to explore the mechanisms underlying the observed improvements. | — |
Countries
Brazil
Contacts
Public ContactAndre Guimarães
Universidade Estadual de Montes Claros
Outcome results
None listed