PMID- 23652897
OWN - NLM
STAT- MEDLINE
DCOM- 20131119
LR  - 20220321
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 12
IP  - 4
DP  - 2013 Apr
TI  - A 12-month, prospective, evaluator-blinded study of small gel particle hyaluronic 
      acid filler in the correction of temporal fossa volume loss.
PG  - 470-5
AB  - OBJECTIVE: The primary objective of this study is to examine the use and 
      persistency of small gel particle hyaluronic acid (SGP-HA) filler (Restylane(R); 
      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.
FAU - Moradi, Amir
AU  - Moradi A
AD  - Moradi MD, Vista, CA, USA. moradimd@gmail.com
FAU - Shirazi, Azadeh
AU  - Shirazi A
FAU - Moradi, Jeanette
AU  - Moradi J
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Gels)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - S270N0TRQY (Restylane)
SB  - IM
MH  - Adult
MH  - *Aging
MH  - *Cosmetic Techniques/adverse effects
MH  - Female
MH  - Follow-Up Studies
MH  - Gels
MH  - Humans
MH  - Hyaluronic Acid/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacology
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Particle Size
MH  - Prospective Studies
MH  - *Rejuvenation
MH  - Severity of Illness Index
MH  - Single-Blind Method
MH  - Surveys and Questionnaires
MH  - Temporal Bone
MH  - Treatment Outcome
EDAT- 2013/05/09 06:00
MHDA- 2013/11/20 06:00
CRDT- 2013/05/09 06:00
PHST- 2013/05/09 06:00 [entrez]
PHST- 2013/05/09 06:00 [pubmed]
PHST- 2013/11/20 06:00 [medline]
AID - S1545961613P0470X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2013 Apr;12(4):470-5.