NCT04519515

Vollure for the Correction of Atrophic Facial Scarring

Double Blind Split Face Randomized Placebo Controlled Clinical Trial Investigating Juvederm Vollure for the Correction of Atrophic Facial Scarring

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Siperstein Dermatology · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atrophic Scar

Interventions

Type	Name	Description
DEVICE	Allergan Vollure	Injection of Allergan Vollure into Atrophic Scars

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-09-17
• Completion: 2023-05-01
• First posted: 2020-08-19
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study