Histopathology Clinical Trial
Official title:
Histological Analysis of Bellafill Injected Tissue at Various Time Points: A Proof of Concept Study
This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.
Visit 1 (day 0): Subjects with pre-planned surgical treatment (mini-abdominoplasty or
redundant abdominal tissue removal) will be enrolled and will receive a Bellafill Skin Test.
Visit 2 (Day 28): Each subject receives treatment with Bellafill into 2 identified
rectangular treatment areas within the pre-planned surgical area (0.1cc injected in the upper
dermis and 0.1cc injected in the deep dermis at the subcutaneous junction).
Visit 3 (1 Week, 1 Month, or 2 Months; or, 3 Months or 6 Months): The timing of Visit 3 (the
final study visit) is dependent on the subject's type of pre-planned surgery. Subjects who
will undergo abdominoplasty will attend Visit 3 at 1 Week, 1 Month or 2 Months after Visit 2.
Subjects who will undergo removal of redundant skin (i.e., dog ear) will attend Visit 3 at 3
Months or 6 Months after Visit 2. Following surgical removal of Bellafill injection sites,
histopathologic analyses will be conducted.
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