Facial AgingHACSNCT07744464
Hyaluronic Acid Crosslinking Clinical Study
A study testing Hyaluronic Acid Dermal Fillers in people with Facial Aging and Skin Aging, run by Antony de Paula Barbosa at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Aging, Skin Aging, Facial Volume Loss
- What is being tested?
- Hyaluronic Acid Dermal Fillers
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Evaluation of Hyaluronic Acid Dermal Fillers With Different Degrees of Divinyl Sulfone Crosslinking: Efficacy, Safety, and Patient Satisfaction
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.
Read the 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.
- Conditions
- Facial Aging, Skin Aging, Facial Volume Loss, Facial Rhytides, Nasolabial Fold, Lip Deformity
- Being tested
- Hyaluronic Acid Dermal Fillers
- Keywords
- Hyaluronic Acid, Dermal Fillers, Safety, Aesthetics, Prospective Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid Dermal FillersDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hyaluronic Acid Dermal Fillers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Day 90
Secondary outcomes (2)
Patient satisfaction
Patient satisfaction will be assessed using Likert-based satisfaction questionnaires and the Net Promoter Score (NPS).
Measured: Day 90
Global Aesthetic Improvement Scale (GAIS)
Aesthetic improvement will be evaluated using the Global Aesthetic Improvement Scale (GAIS).
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Mar 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antony de Paula Barbosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antony de Paula Barbosa, Antony Barbosa Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744464
- Sponsor's protocol ID
- 96439826.5.0000.0315
- Acronym
- HACS
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of Hyaluronic Acid Dermal Fillers With Different Degrees of Divinyl Sulfone Crosslinking: Efficacy, Safety, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07744464
- Acronym / sponsor ID
- HACS / 96439826.5.0000.0315
- Conditions
- Facial Aging, Skin Aging, Facial Volume Loss, Facial Rhytides, Nasolabial Fold, Lip Deformity
- Keywords
- Hyaluronic Acid, Dermal Fillers, Safety, Aesthetics, Prospective Observational Study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Antony de Paula BarbosaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Hyaluronic Acid Dermal FillersParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid Dermal FillersInjectable 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. | Device | Experimental |
Primary outcome
Clinical effectiveness of hyaluronic acid dermal fillers with different degrees of DVS crosslinking
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.
Safety of hyaluronic acid dermal fillers
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.
2 secondary outcomes
Patient satisfaction
Time frame: Day 90
Global Aesthetic Improvement Scale (GAIS)
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid Dermal Fillers in people with Facial Aging and Skin Aging, run by Antony de Paula Barbosa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness of hyaluronic acid dermal fillers with different degrees of DVS crosslinking (time frame: Baseline to Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.