Novel hyaluronic acid dermal filler: dermal gel extra physical properties and clinical outcomes.
BACKGROUND
Dermal gel extra (DGE) is a new, tightly cross-linked hyaluronic acid (HA)-based dermal filler containing lidocaine engineered to resist gel deformation and degradation.


OBJECTIVE
To develop a firmer gel product (DGE) and compare the efficacy and safety of DGE with nonanimal stabilized HA (NASHA) for correction of nasolabial folds (NLFs).


METHODS
DGE physical properties were characterized, and 140 subjects with moderate to deep NLFs were treated with DGE and NASHA in a randomized, multicenter, split-face design study. Efficacy, pain, and satisfaction were measured using appropriate standard instruments. Adverse events were monitored throughout the study.


RESULTS
DGE has a higher modulus and a higher gel:fluid ratio than other HA fillers. Similar optimal correction was observed with DGE and NASHA through 36 weeks (9 months). Study subjects required less volume (p<.001) and fewer touch-ups (p=.005) and reported less injection pain (p<.001) with DGE treatment. Most adverse events were mild to moderate skin reactions.


CONCLUSIONS
DGE is a firm HA gel that required significantly less volume and fewer touch-ups to provide equivalent efficacy to NASHA for NLF correction; both dermal gels were well tolerated. DGE will provide a comfortable and cost-effective dermal filler option for clinicians and patients.
Total Skin and Beauty Dermatology Center, Birmingham, Alabama 35205-5067, USA. monheitgd421@pol.net
Gary D
GD
Monheit
Leslie S
LS
Baumann
Michael H
MH
Gold
David J
DJ
Goldberg
Mitchel P
MP
Goldman
Rhoda S
RS
Narins
Nathan
N
Bachtell
Emily
E
Garcia
Jeffrey
J
Kablik
Julia
J
Gershkovich
David
D
Burkholder
D003432:Cross-Linking Reagents / Q000008:administration & dosage / Q000737:chemistry*; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000737:chemistry*; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D019736:Prostheses and Implants; D015361:Rhytidoplasty / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage / Q000737:chemistry
D003432:Cross-Linking Reagents; D055675:Viscosupplements; D006820:Hyaluronic Acid