Atrophic Acne Scarring Clinical Trial
Official title:
The Use of Bellafill for Atrophic Acne Scar Correction in the Full Facial Area
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.
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.
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