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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.
Full 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:
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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42 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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