OBJECTIVE: The primary objective of this study is to examine the use and persistency of small gel particle hyaluronic acid (SGP-HA) filler (Restylane®; Medicis Aesthetics Inc, Scottsdale, AZ) in the treatment of temporal fossa volumization over a 12-month follow-up, and determine local adverse events (AEs). STUDY DESIGN: This is a US Food and Drug Administration-approved, blinded, prospective, single-center, open-label trial enrolling 20 subjects undergoing subcutaneous injection of SGP-HA for rejuvenation of the temples. Primary outcomes were measured using a standardized grading system—the Hollowness Severity Rating Scale (HSRS)—at each visit by the treating investigator, a blinded physician assessment of randomized photos using the HSRS, and patient questionnaires over a 12-month period. AEs were monitored by the investigator and via patient diaries. RESULTS: At weeks 4, 12, and 24, and month 12, all graders (ie, investigator, blinded physician assessor, and patients) reported improvement overall in hollowness. At baseline, temporal fossa hollowness was measured as moderate to severe. At week 4 to month 12, temporal fossa was graded at none or only mild hollowness. No touch-ups were necessary at week 4 on all subjects. All AEs were mild or moderate and resolved within 2 weeks. CONCLUSION: Our study demonstrates clinically significant efficacy and safety in the use of Restylane for temple augmentation and, thus, facial rejuventation.
RCT Entities:
OBJECTIVE: The primary objective of this study is to examine the use and persistency of small gel particle hyaluronic acid (SGP-HA) filler (Restylane®; Medicis Aesthetics Inc, Scottsdale, AZ) in the treatment of temporal fossa volumization over a 12-month follow-up, and determine local adverse events (AEs). STUDY DESIGN: This is a US Food and Drug Administration-approved, blinded, prospective, single-center, open-label trial enrolling 20 subjects undergoing subcutaneous injection of SGP-HA for rejuvenation of the temples. Primary outcomes were measured using a standardized grading system—the Hollowness Severity Rating Scale (HSRS)—at each visit by the treating investigator, a blinded physician assessment of randomized photos using the HSRS, and patient questionnaires over a 12-month period. AEs were monitored by the investigator and via patient diaries. RESULTS: At weeks 4, 12, and 24, and month 12, all graders (ie, investigator, blinded physician assessor, and patients) reported improvement overall in hollowness. At baseline, temporal fossa hollowness was measured as moderate to severe. At week 4 to month 12, temporal fossa was graded at none or only mild hollowness. No touch-ups were necessary at week 4 on all subjects. All AEs were mild or moderate and resolved within 2 weeks. CONCLUSION: Our study demonstrates clinically significant efficacy and safety in the use of Restylane for temple augmentation and, thus, facial rejuventation.
Authors: Jean Carruthers; Derek Jones; Bhushan Hardas; Diane K Murphy; Lisa Donofrio; Jonathan M Sykes; Alastair Carruthers; Lela Creutz; Ann Marx; Sara Dill Journal: Dermatol Surg Date: 2016-10 Impact factor: 3.398