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.
Study Type
OBSERVATIONAL
Enrollment
10
Bellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis \& deep dermis).
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Danville, California, United States
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Time frame: 1 week
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Time frame: 1 month
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Time frame: 2 months
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Time frame: 3 months
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Time frame: 6 months
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