Sunday, October 28, 2007
13478

Assessment of Adverse Experiences, Keloid Formation and Pigmentary Changes in Subjects with Fitzpatrick Skin Types 4, 5, or 6 Injected with Hyaluronic Acid Gel Dermal Fillers

Susan Taylor, MD and Cheryl Burgess, MD.

Purpose: One of the purposes of this study was to identify the incidences of local adverse events, keloid formation and dermal pigmentary changes following injection of hyaluronic acid gel dermal fillers in subjects with Fitzpatrick Skin Types 4, 5, or 6. Methodology: A randomized, comparative, blinded-patient and blinded-photographic evaluator, baseline-controlled clinical study of the safety and efficacy of RestylaneŽ and PerlaneŽ enrolled subjects with Fitzpatrick Skin Types 4, 5, or 6 (majority of subjects were African-American). Subjects were implanted with both study products in the nasolabial fold (and oral commissures as necessary). One side of the face was randomly assigned to implantation with PerlaneŽ; the opposite side was implanted with RestylaneŽ. Physician assessments were done at 3 days and 2, 6, 12, and 24 weeks for adverse experience, evaluation of skin pigmentation changes, and keloid formation. Subjects maintained diaries for 2 weeks following initial implantation; recorded complaints were included in the safety assessment. Results: One hundred and fifty patients (female, n=140; male, n=10) were evaluated. Fitzpatrick Skin Type distribution was: Type 4, 29.3%; Type 5, 45.3%; Type 6, 25.3%. One hundred and three treatment-related, site specific, local adverse experiences were reported. More than 90% of reported local reactions related to bruising, tenderness, edema, redness, itching, pain, and pigmentary changes. Pigmentary changes occurred in 5% to 7% of injection sites (PerlaneŽ; n=24; RestylaneŽ, n=15). Twenty-three subjects (PerlaneŽ; n=9; RestylaneŽ, n=14), had pigmentation changes at the nasolabial fold or oral commissures; all were mild or moderate in severity and resolved within 12 weeks. No keloids were reported during the study. The incidence, severity, and duration of adverse experiences were as expected and consistent with the known profiles of hyaluronic acid gel dermal fillers. RestylaneŽ and PerlaneŽ did not differ in the incidence and severity of adverse experiences. Conclusions: PerlaneŽ and RestylaneŽ were safe and effective at correction of facial folds and wrinkles, including the nasolabial folds, in subjects with Fitzpatrick Skin Types 4, 5, or 6. No unexpected adverse experiences were reported. Pigmentary changes occurred in 5% to 7% of injection sites and were mostly moderate to mild and transitory (up to 12 weeks). No subject developed keloids during the study.