Atrophic ScarJVASNCT04519515
Vollure for the Correction of Atrophic Facial Scarring
A study testing Allergan Vollure in people with Atrophic Scar, run by Siperstein Dermatology at 1 site in United States.
Trial summary
Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrophic Scar
- What is being tested?
- Allergan Vollure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 1 May 2023
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good general health as evidenced by medical history
- For females of reproductive potential: use of highly effective contraception and a negative urine pregnancy test at screening and all injection visits.
- Score of 4-55 on a validated scarring grading system
Who cannot join
- Subjects with allergies to hyaluronic acid filler, gram positive bacteria or lidocaine.
- Subjects with auto-immune conditions
- Subjects with diabetes
- Subjects with a history of sever anaphylactic reactions
- Subjects with cancer, or other life-threatening medical condition
- Subjects taking anti---coagulants, chemotherapy, immunosuppressive agents, immunomodulatory agents, diuretics, anti---histamines, or anti---inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the first 120 days of the study.
Show all 21Show fewer
- Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery.
- Subjects who had neuromodulators in the past 6 months or hyaluronic acid fillers in the previous year on the face
- Subjects who at any time had surgery or more permanent fillers in the face such as Bellafill or Radiesse
- Subjects with tattoos or many skin growths on the face that would obscure visualization of the scars
- Subjects with a history of keloid or hypertrophic scar on the face
- Subjects unwilling or unable to sit still while an injector places Juvéderm Vollure in the face
- Subjects unwilling or unable to keep their head still during the photos
- Subjects who are pregnant or nursing
- Female subjects of child-bearing potential unable to take or use some form of birth control
- Subjects with any facial bruising or swelling
- Subjects with current skin infections, tumors, herpes outbreak or dermatitis on the face
- Subjects using skin-irritating topical preparations, pigmenting agents (self-tanning or bleaching creams), in the past two weeks or for the first 120 days of the study on the face
- Any medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
- Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
- Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employee.
Trial locations and contacts
1 site in 1 country.
United States1 site
Siperstein Dermatology Group
Boynton Beach, Florida, 33472
About this study
Official title: Double Blind Split Face Randomized Placebo Controlled Clinical Trial Investigating Juvederm Vollure for the Correction of Atrophic Facial Scarring
Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
Read the detailed description
Subjects with grades ranging from 4-55 on the Quantitative Global Scarring Grading System (QGSGS)1 will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated if optimal correction on the active intervention side has not been achieved according to the treating investigator. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. The subjects will be eligible to receive treatment with Juvéderm Vollure 90 days after their last treatment on the placebo-controlled side if they choose. In addition, at 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
- Conditions
- Atrophic Scar
- Being tested
- Allergan Vollure
- Keywords
- Hyaluronic Acid Filler, Atrophic Scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergan VollureDevice
Injection of Allergan Vollure into Atrophic Scars
| Study group | Role | What they receive |
|---|---|---|
| Treatment With Juvederm Vollure Right | Experimental | Injection of Juvederm Vollure on one half of the face, placebo on the other side Receives: Device: Allergan Vollure |
| Treatment Juvederm Vollure Left | Experimental | Injection of Juvederm Vollure on one half of the face, placebo on the other side Receives: Device: Allergan Vollure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitiative Global Scaring Grading System (QGSGS) score
Difference in the mean QGSGS score from baseline to 90 days after injection in active group. The QGSGS score ranges from 0 to 84 and a higher score signifies a worse condition.
Measured: Baseline to 90 days after last injection
Secondary outcomes (5)
Adverse Events
The difference in number of adverse events from control and active treatment group
Measured: Baseline to 90 days after last injection
Global Aesthetic Improvement Scale (GAIS)
Difference in the mean GAIS score from baseline to 90 days after injection. The scale is a 5 point scale from -1 to 3. A higher score signifies more improvement, a negative score signifies worsening of the condition.
Measured: Baseline to 90 days after last injection
24 Month Global Aesthetic Improvement Scale (GAIS) Results
Difference in the mean GAIS score from baseline to 24 months after injection. The scale is a 5 point scale from -1 to 3. A higher score signifies more improvement, a negative score signifies worsening of the condition.
Measured: 24 months after 1st injection
24 Month Quantitiative Global Scaring Grading System (QGSGS) Results
Difference in the mean QGSGS score from baseline to 24 months after injection. The QGSGS score ranges from 0 to 84 and a higher score signifies a worse condition.
Measured: 24 months after 1st injection
Result of Placebo Group based on the Quantitiative Global Scaring Grading System (QGSGS)
Difference in the mean QGSGS score from baseline to 90 days after injection of placebo group. The QGSGS score ranges from 0 to 84 and a higher score signifies a worse condition.
Measured: Baseline to 90 days after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start11 Nov 2020
- Primary completion17 Sep 2021
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic ScarStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siperstein Dermatology
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519515
- Sponsor's protocol ID
- JVAS002
- Acronym
- JVAS
- Status last verified
- Feb 2021
- First submitted
- 16 Aug 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Split Face Randomized Placebo Controlled Clinical Trial Investigating Juvederm Vollure for the Correction of Atrophic Facial Scarring
- ClinicalTrials.gov ID
- NCT04519515
- Acronym / sponsor ID
- JVAS / JVAS002
- Conditions
- Atrophic Scar
- Keywords
- Hyaluronic Acid Filler, Atrophic Scar
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Siperstein DermatologyUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 19 Aug 2020 (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.
Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
Detailed description
Subjects with grades ranging from 4-55 on the Quantitative Global Scarring Grading System (QGSGS)1 will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated if optimal correction on the active intervention side has not been achieved according to the treating investigator. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. The subjects will be eligible to receive treatment with Juvéderm Vollure 90 days after their last treatment on the placebo-controlled side if they choose. In addition, at 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment With Juvederm Vollure Right | Experimental | Device: Allergan VollureInjection of Juvederm Vollure on one half of the face, placebo on the other side |
| Treatment Juvederm Vollure Left | Experimental | Device: Allergan VollureInjection of Juvederm Vollure on one half of the face, placebo on the other side |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In good general health as evidenced by medical history
- For females of reproductive potential: use of highly effective contraception and a negative urine pregnancy test at screening and all injection visits.
- Score of 4-55 on a validated scarring grading system
Key exclusion criteria (21 listed)
- Subjects with allergies to hyaluronic acid filler, gram positive bacteria or lidocaine.
- Subjects with auto-immune conditions
- Subjects with diabetes
- Subjects with a history of sever anaphylactic reactions
- Subjects with cancer, or other life-threatening medical condition
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 |
|---|---|---|
| Allergan VollureInjection of Allergan Vollure into Atrophic Scars | Device | Treatment Juvederm Vollure Left, Treatment With Juvederm Vollure Right |
Primary outcome
Quantitiative Global Scaring Grading System (QGSGS) score
Time frame: Baseline to 90 days after last injection
Difference in the mean QGSGS score from baseline to 90 days after injection in active group. The QGSGS score ranges from 0 to 84 and a higher score signifies a worse condition.
5 secondary outcomes
Adverse Events
Time frame: Baseline to 90 days after last injection
Global Aesthetic Improvement Scale (GAIS)
Time frame: Baseline to 90 days after last injection
24 Month Global Aesthetic Improvement Scale (GAIS) Results
Time frame: 24 months after 1st injection
24 Month Quantitiative Global Scaring Grading System (QGSGS) Results
Time frame: 24 months after 1st injection
Result of Placebo Group based on the Quantitiative Global Scaring Grading System (QGSGS)
Time frame: Baseline to 90 days after last injection
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 15 Feb 2022.
- 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 Allergan Vollure in people with Atrophic Scar, run by Siperstein Dermatology at 1 site in United States.
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 3 inclusion and 21 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 15 Feb 2022. 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 United States. 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?
Quantitiative Global Scaring Grading System (QGSGS) score (time frame: Baseline to 90 days after last injection). 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 15 Feb 2022.