Vollure for the Correction of Atrophic Facial Scarring (JVAS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrophic Scar
• Intervention / Treatment: Device: Allergan Vollure

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Siperstein Dermatology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment With Juvederm Vollure Right; Injection of Juvederm Vollure on one half of the face, placebo on the other side	Device: Allergan Vollure; Injection of Allergan Vollure into Atrophic Scars
Experimental: Treatment Juvederm Vollure Left; Injection of Juvederm Vollure on one half of the face, placebo on the other side	Device: Allergan Vollure; Injection of Allergan Vollure into Atrophic Scars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 90 days after last injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The difference in number of adverse events from control and active treatment group	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.	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.	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.	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.	Baseline to 90 days after last injection

Collaborators and Investigators

• Sponsor: Siperstein Dermatology
• Collaborators: Allergan

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): September 17, 2021
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Hyaluronic Acid Filler; Atrophic Scar
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: JVAS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes