Instituto Antony Barbosa
Belo Horizonte, Minas Gerais, 30493-240, Brazil
NCT Number: NCT07744464
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Belo Horizonte, Minas Gerais, 30493-240, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Able to undergo standardized photographic documentation, three-dimensional facial imaging (Vectra® 3D), ultrasonography, and patient-reported outcome assessments.
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 90
Patient satisfaction will be assessed using Likert-based satisfaction questionnaires and the Net Promoter Score (NPS).
Time frame: Day 90
Aesthetic improvement will be evaluated using the Global Aesthetic Improvement Scale (GAIS).
Antony de Paula Barbosa
Other
Prospective Clinical Evaluation of Hyaluronic Acid Dermal Fillers With Different Degrees of Divinyl Sulfone Crosslinking: Efficacy, Safety, and Patient Satisfaction
Acronym: HACS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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