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Vollure for the Correction of Atrophic Facial Scarring (JVAS)

Primary Purpose

Atrophic Scar

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allergan Vollure
Sponsored by
Siperstein Dermatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Scar focused on measuring Hyaluronic Acid Filler, Atrophic Scar

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Siperstein Dermatology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment With Juvederm Vollure Right

Treatment Juvederm Vollure Left

Arm Description

Injection of Juvederm Vollure on one half of the face, placebo on the other side

Injection of Juvederm Vollure on one half of the face, placebo on the other side

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events
The difference in number of adverse events from control and active treatment group
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.
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.
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.
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.

Full Information

First Posted
August 16, 2020
Last Updated
February 11, 2022
Sponsor
Siperstein Dermatology
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT04519515
Brief Title
Vollure for the Correction of Atrophic Facial Scarring
Acronym
JVAS
Official Title
Double Blind Split Face Randomized Placebo Controlled Clinical Trial Investigating Juvederm Vollure for the Correction of Atrophic Facial Scarring
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
September 17, 2021 (Actual)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Siperstein Dermatology
Collaborators
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Scar
Keywords
Hyaluronic Acid Filler, Atrophic Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment With Juvederm Vollure Right
Arm Type
Experimental
Arm Description
Injection of Juvederm Vollure on one half of the face, placebo on the other side
Arm Title
Treatment Juvederm Vollure Left
Arm Type
Experimental
Arm Description
Injection of Juvederm Vollure on one half of the face, placebo on the other side
Intervention Type
Device
Intervention Name(s)
Allergan Vollure
Intervention Description
Injection of Allergan Vollure into Atrophic Scars
Primary Outcome Measure Information:
Title
Quantitiative Global Scaring Grading System (QGSGS) score
Description
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.
Time Frame
Baseline to 90 days after last injection
Secondary Outcome Measure Information:
Title
Adverse Events
Description
The difference in number of adverse events from control and active treatment group
Time Frame
Baseline to 90 days after last injection
Title
Global Aesthetic Improvement Scale (GAIS)
Description
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.
Time Frame
Baseline to 90 days after last injection
Title
24 Month Global Aesthetic Improvement Scale (GAIS) Results
Description
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.
Time Frame
24 months after 1st injection
Title
24 Month Quantitiative Global Scaring Grading System (QGSGS) Results
Description
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.
Time Frame
24 months after 1st injection
Title
Result of Placebo Group based on the Quantitiative Global Scaring Grading System (QGSGS)
Description
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.
Time Frame
Baseline to 90 days after last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
Siperstein Dermatology Group
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vollure for the Correction of Atrophic Facial Scarring

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