Hyaluronic Acid Crosslinking Clinical Study

NCT07744464 | Active Not Recruiting

• 1 other identifier: 96439826.5.0000.0315
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Aging; Skin Aging; Facial Volume Loss; Facial Rhytides; Nasolabial Fold; Lip Deformity; Jawline Contour Deformity; Chin Deformity

Keywords

Hyaluronic Acid; Dermal Fillers; Safety; Aesthetics; Prospective Observational Study

Outcome Measures

Primary Outcomes (2)

• Clinical effectiveness of hyaluronic acid dermal fillers with different degrees of DVS crosslinking

  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.

  Baseline to Day 90

• Safety of hyaluronic acid dermal fillers

  Safety will be assessed through the systematic recording of immediate and delayed adverse events, complications, and tolerability during the entire follow-up period.

  Baseline to Day 90

Secondary Outcomes (2)

• Patient satisfaction

  Day 90

• Global Aesthetic Improvement Scale (GAIS)

  Day 90

Study Arms (1)

Experimental

EXPERIMENTAL

Participants receiving facial treatment with hyaluronic acid dermal fillers with different degrees of divinyl sulfone (DVS) crosslinking according to the clinical indication. Clinical outcomes, safety, and patient satisfaction will be evaluated over a 90-day follow-up period using standardized clinical, imaging, and patient-reported outcome assessments.

Device: Hyaluronic Acid Dermal Fillers

Interventions

Hyaluronic Acid Dermal Fillers DEVICE

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antony de Paula Barbosa: lead

Study Sites (1)

Instituto Antony Barbosa

Belo Horizonte, Minas Gerais, 30493-240, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Antony de Paula Barbosa

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: March 1, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)