NCT02642627

The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Suneva Medical, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, prospective pilot study assessing the efficacy and safety of Bellafill for correction of distensible atrophic acne scars in the full facial area. All enrolled subjects will receive initial treatment with Bellafill, as well as touch-up treatments (if necessary to achieve optimal correction). Subjects will be evaluated at Screening (Month -1), Day 0 (Baseline) Month 1, Month 4, and Month 7.

Detailed description

Correctable acne scars will be individually identified and only scars that the Investigator determines to be correctable will receive study treatment. All eligible scars within the treatment area will be treated. Bellafill should be injected using a standard tunneling technique whereby the filler is injected in a retrograde manner utilizing several passes until the scar reaches a desired level of correction. A touch-up treatment is allowed if additional treatment is required to achieve optimal correction. Treatment Area There will be four "quadrants" of the face where treatment is allowed and grading will occur. The glabellar, nose and upper lip areas are not to be treated: * The glabellar "no treatment" zone is defined as the area between the mid-pupillary lines up to 2 cm above the highest point of the eyebrow. This area will not receive treatment; * The no treatment area of the nose extends from the nasal bridge (and is contiguous with the glabellar no treatment zone) to the nasal sill and laterally to the cheek; * The upper lip will be defined as the area from the vermillion border of the upper lip to the nasal sill superiorly and the nasolabial fold laterally; * The face is split at the midline of the forehead and the chin and where the nose meets the cheek, creating two halves. Each half is then divided into upper and lower quadrants by a line extending from the lateral canthus to the superior junction of the pinna and the cheek. Each quadrant will be graded individually and receive a separate grade. The no treatment zones of the glabella, nose and upper lip should be respected as they have been selected to maximize the safety of the subject. A "touch-up treatment" is permitted at study Visit 3 (Month 1). The Investigator will evaluate each lesion and determine if a treated scar is undercorrected and whether additional improvement could be obtained with a touch-up treatment.

Conditions

• Atrophic Acne Scarring

Interventions

Type	Name	Description
DEVICE	Bellafill

Timeline

• Start date: 2015-11-18
• Primary completion: 2017-01-27
• Completion: 2017-01-27
• First posted: 2015-12-30
• Last updated: 2020-04-06
• Results posted: 2020-04-06

Locations

1 site across 1 country: United States