Chin Deformity, Facial Aging, Facial Rhytides, Facial Volume Loss, Jawline Contour Deformity, Lip Deformity, Nasolabial Fold, Skin Aging
Conditions
Keywords
Hyaluronic Acid, Dermal Fillers, Safety, Aesthetics, Prospective Observational Study
Brief summary
This prospective observational case series aims to evaluate the clinical efficacy, safety, and patient satisfaction associated with hyaluronic acid dermal fillers with different degrees of divinyl sulfone (DVS) crosslinking. Twenty adult participants undergoing facial aesthetic treatment will be followed for 90 days. Clinical outcomes will be assessed using three-dimensional imaging (Vectra® 3D), soft tissue ultrasonography, the Global Aesthetic Improvement Scale (GAIS), Net Promoter Score (NPS), Likert satisfaction scales, and standardized adverse event monitoring.
Detailed description
Hyaluronic acid (HA) dermal fillers are widely used in facial aesthetic medicine because of their biocompatibility, hydration capacity, and volumizing properties. Crosslinking is an essential manufacturing process that enhances the mechanical stability, rheological properties, and clinical longevity of HA hydrogels. Different degrees of divinyl sulfone (DVS) crosslinking may influence tissue integration, lifting capacity, volumetric performance, and safety profile, potentially affecting clinical outcomes in different facial indications. This prospective observational case series aims to evaluate the clinical performance of HA dermal fillers with different degrees of DVS crosslinking in routine clinical practice. Twenty adult participants with indications for facial aesthetic treatment will be allocated according to clinical indication and the crosslinking characteristics of the filler used. Treatments will include applications for skin quality improvement, lip and perioral enhancement, jawline and chin contouring, and midface, zygomatic, piriform fossa, and nasolabial fold correction. Participants will be followed for 90 days, with evaluations performed at baseline (Day 0), Day 30, Day 60, and Day 90. Clinical efficacy will be assessed using three-dimensional stereophotogrammetry (Vectra® 3D), soft tissue ultrasonography, and standardized clinical evaluation. Patient-reported outcomes will include the Global Aesthetic Improvement Scale (GAIS), Net Promoter Score (NPS), and Likert-based satisfaction questionnaires. Safety will be evaluated through systematic recording of immediate and delayed adverse events throughout the study period. The study is designed to characterize the clinical behavior of HA fillers with different crosslinking degrees, exploring their efficacy, safety, and patient satisfaction across distinct facial treatment indications. The findings are expected to contribute to evidence-based clinical decision-making and to improve treatment planning for facial aesthetic procedures.
Interventions
Injectable hyaluronic acid dermal fillers with different degrees of divinyl sulfone (DVS) crosslinking administered according to the approved clinical indication and the investigator's treatment plan for facial aesthetic correction.
Sponsors
Antony de Paula Barbosa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study. Participants, investigators, and care providers are aware of the intervention administered. Outcome assessments include standardized clinical photographs, Vectra® 3D imaging, ultrasonography, and validated patient-reported outcome measures.
Intervention model description
Single-group interventional study evaluating hyaluronic acid dermal fillers with different degrees of DVS crosslinking in facial aesthetic indications. Participants receive the clinically indicated treatment and are followed prospectively for efficacy, safety, and patient satisfaction outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 years or older. Male or female participants. Seeking facial aesthetic treatment with hyaluronic acid dermal fillers. Clinical indication for treatment according to the investigator's assessment. Willing and able to provide written informed consent. Willing to comply with all scheduled visits, assessments, and follow-up procedures. Able to undergo standardized photographic documentation, three-dimensional facial imaging (Vectra® 3D), ultrasonography, and patient-reported outcome assessments.
Exclusion criteria
* Pregnancy or breastfeeding. Known hypersensitivity to hyaluronic acid or any component of the dermal filler. Active infection, inflammation, or skin disease at the intended treatment site. Previous facial aesthetic procedure that could interfere with study assessments, according to the investigator's judgment. Participation in another clinical study that could affect study outcomes. Any medical condition considered by the investigator to make participation unsafe or interfere with study evaluations. Inability or unwillingness to complete the follow-up schedule or study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effectiveness of hyaluronic acid dermal fillers with different degrees of DVS crosslinking | Baseline to Day 90 | Clinical effectiveness will be evaluated using standardized clinical assessment, three-dimensional stereophotogrammetry (Vectra® 3D), and soft tissue ultrasonography to assess treatment-related changes throughout the 90-day follow-up period. |
| Safety of hyaluronic acid dermal fillers | Baseline to Day 90 | Safety will be assessed through the systematic recording of immediate and delayed adverse events, complications, and tolerability during the entire follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Day 90 | Patient satisfaction will be assessed using Likert-based satisfaction questionnaires and the Net Promoter Score (NPS). |
| Global Aesthetic Improvement Scale (GAIS) | Day 90 | Aesthetic improvement will be evaluated using the Global Aesthetic Improvement Scale (GAIS). |
Countries
Brazil
Outcome results
None listed