Vollure for the Correction of Atrophic Facial Scarring

NCT04519515 | Unknown FDA Device

• 1 other identifier: JVAS002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Scar

Keywords

Hyaluronic Acid Filler; Atrophic Scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adverse Events

  Baseline to 90 days after last injection

• Global Aesthetic Improvement Scale (GAIS)

  Baseline to 90 days after last injection

• 24 Month Global Aesthetic Improvement Scale (GAIS) Results

  24 months after 1st injection

• 24 Month Quantitiative Global Scaring Grading System (QGSGS) Results

  24 months after 1st injection

• Result of Placebo Group based on the Quantitiative Global Scaring Grading System (QGSGS)

  Baseline to 90 days after last injection

Study Arms (2)

Treatment With Juvederm Vollure Right

EXPERIMENTAL

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

Device: Allergan Vollure

Treatment Juvederm Vollure Left

EXPERIMENTAL

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

Device: Allergan Vollure

Interventions

Allergan Vollure DEVICE

Injection of Allergan Vollure into Atrophic Scars

Treatment Juvederm Vollure Left; Treatment With Juvederm Vollure Right

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siperstein Dermatology: lead
• Allergan: collaborator

Study Sites (1)

Siperstein Dermatology Group

Boynton Beach, Florida, 33472, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: November 11, 2020
• Primary Completion: September 17, 2021
• Study Completion: May 1, 2023
• Last Updated: February 15, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)