A Multicenter, Double-Blinded, Randomized, Split-Face Study of the Safety and Efficacy of a Novel Hyaluronic Acid Gel for the Correction of Nasolabial Folds
January 2018 | Volume 17 | Issue 1 | Original Article | 66 | Copyright © 2018
Michael H. Gold MD,a Leslie Stafford Baumann MD CPI,b Clifford P. Clark III MD,c and Joel Schlessinger MDd
aTennessee Clinical Research Center, Nashville, TN bBaumann Cosmetic & Research Institute, Miami, FL cOrlando Aesthetic Institute, Orlando, FL dSkin Specialists, PC, Omaha, NE
BACKGROUND: Injectable hyaluronic acid is frequently used to correct volume loss in nasolabial folds. OBJECTIVE: To compare the safety and efficacy of a novel hyaluronic acid gel to a non-animal stabilized hyaluronic acid (Comparator) gel for the correction of nasolabial folds (NLF). METHODS: Qualified subjects had NLF with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe). NLFs were treated with Test Product on one side of the face and Comparator on the other side of the face (facial side randomly assigned). Improvement from baseline was evaluated at weeks 1, 2, 4, 12, and 24 weeks. The primary study endpoint was the mean change in WSRS score from baseline to week 24. RESULTS: The mean changes in WSRS score from baseline were 1.02 ±0.689 for Test Product and 0.91±0.762 for Comparator. The mean difference in change from baseline in WSRS scoring (Comparator minus Test Product) at week 24 was -0.11 (-0.225-0.001, 95% confidence interval [CI]). The upper boundary (0.001) of the 95% CI was less than the prespecified non-inferiority limit of 0.50, indicating that the Test Product was non-inferior to the Comparator. No subject discontinued the study due to adverse events. CONCLUSION: The Test Product is safe and non-inferior to the Comparator for the correction of nasolabial folds. The Test Product was associated with less swelling, pain, and overall severity of treatment-emergent adverse events than the Comparator.
J Drugs Dermatol. 2018;17(1):66-73.
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Hyaluronic acid (HA) is a glycosaminoglycan disaccharide found in the extracellular matrix of the skin, eye, and cartilage. Approximately half of human HA occurs in the skin. As a polyanionic polymer, HA is soluble and binds well with water.1HA provides structure and moisture in human skin. As skin ages, dermal HA decreases and results in reduced water-binding capacity, reduced elasticity, volume loss, and the development of rhytids and other aging features.2,3HA has several characteristics that make it suitable for use as a dermal filler. Because the chemical structure of HA is the same in all species, immunologic reactions and implant rejection are unlikely to occur.3-5 Other favorable characteristics are its presence in the skin and its ability to bind to substantial amounts of water.5 HA readily dissolves in water and forms a viscous gel.3 Unmodified HA, however, has a half-life of only a few weeks after injection into the dermis6 because it is quickly degraded by hyaluronidase and free radicals in the skin.5 To increase stability and longevity when injected into skin, manufacturers use crosslinking agents to bind HA polymer chains to each other. The result is a gel that resists enzymatic and free radical breakdown.5,7 The crosslinking agent used to stabilize most HA-based dermal fillers is 1,4-butanediol diglycidyl ether (BDDE).8 A variety of HA-based crosslinked fillers have been developed to correct facial wrinkles and folds, such as the nasolabial folds (NLF). Examples of FDA-approved crosslinked HA-based fillers are shown in Table 1.The purpose of the present study was to compare the safety and efficacy of a novel HA gel to an established HA gel for the correction of NLF. Both products are non-animal stabilized HA gels.
Subjects (n=163, 156 females, aged 30 to 77 years, mean 55.4±10.1) enrolled in this Quorum IRB-approved study performed in accordance with Good Clinical Practice guidelines. Informed consent was obtained for all subjects.