PMID- 19807760
OWN - NLM
STAT- MEDLINE
DCOM- 20091221
LR  - 20220331
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 35 Suppl 2
DP  - 2009 Oct
TI  - Safety of nonanimal stabilized hyaluronic acid dermal fillers in patients with 
      skin of color: a randomized, evaluator-blinded comparative trial.
PG  - 1653-60
LID - 10.1111/j.1524-4725.2009.01344.x [doi]
AB  - BACKGROUND: Nonanimal stabilized hyaluronic acid (NASHA) dermal fillers have been 
      used in the United States since 2003 for the treatment of moderate to severe 
      facial wrinkles and folds, such as nasolabial folds. Previous trials with NASHA 
      dermal fillers have included small numbers of patients with pigmented skin. 
      OBJECTIVES: This randomized, evaluator-blinded, split-face trial compared the 
      safety and efficacy of two variable-particle NASHA fillers in the correction of 
      nasolabial folds in patients with Fitzpatrick skin types IV, V, and VI. METHODS 
      AND MATERIALS: One hundred fifty patients (predominantly African American) were 
      enrolled at 10 sites. Patients received one treatment (with an optional touch-up 
      treatment at week 2) with small- and large-particle NASHA gel randomized to the 
      left or right side of the face. Safety was evaluated through patient diaries for 
      the first 2 weeks and physician assessments at 3 days and 2, 6, 12, and 24 weeks 
      after treatment for adverse events (AEs), skin pigmentation changes, and keloid 
      formation. RESULTS: All related AEs were mild or moderate and of limited 
      duration. They included bruising, tenderness, edema, redness, itching, pain, and 
      changes in pigmentation. The incidence of AEs was not different between the 2 
      preparations, and no patient developed a keloid. There were 3 reported mass 
      formations, 2 of which were infectious in nature. CONCLUSION: In patients with 
      skin of color, NASHA dermal fillers are safe for the correction of moderate to 
      severe facial folds and wrinkles, with no immunogenicity or keloid formation and 
      only mild to moderate AEs occurring around the injection site.
FAU - Taylor, Susan C
AU  - Taylor SC
AD  - Society Hill Dermatology, Philadelphia, Pennsylvania 19107, USA. 
      taylorderm@aol.com
FAU - Burgess, Cheryl M
AU  - Burgess CM
FAU - Callender, Valerie D
AU  - Callender VD
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Biocompatible Materials)
RN  - 0 (Dermatologic Agents)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Biocompatible Materials/administration & dosage/*adverse effects
MH  - Dermatologic Agents/administration & dosage/*adverse effects
MH  - Erythema/chemically induced
MH  - Face
MH  - Female
MH  - Humans
MH  - Hyaluronic Acid/administration & dosage/*adverse effects
MH  - Hyperpigmentation/*chemically induced
MH  - Injections, Intradermal/*methods
MH  - Male
MH  - Middle Aged
MH  - Philadelphia
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - Skin Aging/*drug effects
MH  - Treatment Outcome
EDAT- 2009/11/18 06:00
MHDA- 2009/12/22 06:00
CRDT- 2009/10/08 06:00
PHST- 2009/10/08 06:00 [entrez]
PHST- 2009/11/18 06:00 [pubmed]
PHST- 2009/12/22 06:00 [medline]
AID - DSU1344 [pii]
AID - 10.1111/j.1524-4725.2009.01344.x [doi]
PST - ppublish
SO  - Dermatol Surg. 2009 Oct;35 Suppl 2:1653-60. doi: 
      10.1111/j.1524-4725.2009.01344.x.