Ann Dermatol.  2016 Jun;28(3):297-303. 10.5021/ad.2016.28.3.297.

A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds

Affiliations
  • 1Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. csesnumd@gmail.com gylee0716@daum.net
  • 2Department of Dermatology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
  • 3Bright and Clear Dermatology Clinic, Seoul, Korea.
  • 4Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. csesnumd@gmail.com gylee0716@daum.net

Abstract

BACKGROUND
Mannitol containing monophasic filler with higher crosslinking has not been well studied for moderate and severe nasolabial fold (NLF) correction.
OBJECTIVE
To compare the efficacy and safety of a novel mannitol containing hyaluronic acid (HA) filler (HA-G) with biphasic HA filler (HA-P) for moderate and severe NLF correction.
METHODS
Thirteen subjects with symmetric moderate to severe NLF received HA-G (in one NLF) and HA-P (in other NLF) and were evaluated for 24 weeks.
RESULTS
At both 12 and 24 weeks, the mean improvement in Genzyme 6-point grading scale from baseline was significantly greater in the side of face that was treated with HA-G than HA-P (1.96±0.91 vs. 1.54±0.73 at week 12; p=0.044, 1.88±0.78 vs. 1.3±0.79 at week 24; p=0.027, respectively). At 12 weeks, the mean Global Aesthetic Improvement Scale score was 2.92±0.93 for HA-G and 2.31±0.95 for HA-P (p=0.008). Both fillers were well tolerated.
CONCLUSION
The HA filler HA-G provides better efficacy and similar local tolerability compared with HA-P in 6 months following treatment for moderate and severe NLF.

Keyword

Dermal filler; Hyaluronic acid; Mannitol; Nasolabial fold

MeSH Terms

Dermal Fillers*
Hyaluronic Acid*
Mannitol*
Nasolabial Fold*
Dermal Fillers
Hyaluronic Acid
Mannitol

Figure

  • Fig. 1 Mean improvement from baseline in Genzyme 6-point grading scale score based on assessments by evaluating experts (*p≤0.05). HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

  • Fig. 2 Proportion of subjects who showed great improvement (≥2 reduction of Genzyme 6-point grading scale score). HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

  • Fig. 3 Mean GAIS score at 4 weeks and 12 weeks after treatment (*p≤0.05). HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden), GAIS: global aesthetic improvement scale.

  • Fig. 4 Subject (61 years/female) with dermal injection of HA-P in right nasolabial fold (NLF) and HA-G in left NLF. Genzyme 6-point grading scale change from baseline to 24 weeks. Right: HA-P, 3.6 to 2.3; left: HA-G, 3.3 to 0.3. (A) Baseline, (B) 4 weeks, (C) 12 weeks, and (D) 24 weeks after treatment. HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

  • Fig. 5 Subject (42 years/female) with dermal injection of HA-G in right nasolabial fold (NLF) and HA-P in left NLF. Genzyme 6-point grading scale changed from baseline to 24 weeks. Right: HA-G, 3.6 to 0.3; left: HA-P, 3 to 0.6. (A) Baseline, (B) 4 weeks, (C) 12 weeks, and (D) 24 weeks after treatment. HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).


Reference

1. Kim H, Park KY, Choi SY, Koh HJ, Park SY, Park WS, et al. The efficacy, longevity, and safety of combined radiofrequency treatment and hyaluronic acid filler for skin rejuvenation. Ann Dermatol. 2014; 26:447–456.
Article
2. Gold M. The science and art of hyaluronic acid dermal filler use in esthetic applications. J Cosmet Dermatol. 2009; 8:301–307.
Article
3. Andre P. Hyaluronic acid and its use as a "rejuvenation" agent in cosmetic dermatology. Semin Cutan Med Surg. 2004; 23:218–222.
Article
4. Carruthers A, Carruthers J. Non-animal-based hyaluronic acid fillers: scientific and technical considerations. Plast Reconstr Surg. 2007; 120:33S–40S.
Article
5. Wang F, Garza LA, Kang S, Varani J, Orringer JS, Fisher GJ, et al. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged human skin. Arch Dermatol. 2007; 143:155–163.
Article
6. Ohrem HL, Schornick E, Kalivoda A, Ognibene R. Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms? Pharm Dev Technol. 2014; 19:257–262.
Article
7. Andrews RJ, Bringas JR, Muto RP. Effects of mannitol on cerebral blood flow, blood pressure, blood viscosity, hematocrit, sodium, and potassium. Surg Neurol. 1993; 39:218–222.
Article
8. Goodman GJ, Bekhor P, Rich M, Rosen RH, Halstead MB, Rogers JD. A comparison of the efficacy, safety, and longevity of two different hyaluronic acid dermal fillers in the treatment of severe nasolabial folds: a multicenter, prospective, randomized, controlled, single-blind, withinsubject study. Clin Cosmet Investig Dermatol. 2011; 4:197–205.
Article
9. Ascher B, Bayerl C, Brun P, Kestemont P, Rzany B, Poncet M, et al. Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines-6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Dermatol. 2011; 10:94–98.
Article
10. Nast A, Reytan N, Hartmann V, Pathirana D, Bachmann F, Erdmann R, et al. Efficacy and durability of two hyaluronic acid-based fillers in the correction of nasolabial folds: results of a prospective, randomized, double-blind, actively controlled clinical pilot study. Dermatol Surg. 2011; 37:768–775.
Article
11. Monheit GD, Gendler EC, Poff B, Fleming L, Bachtell N, Garcia E, et al. Development and validation of a 6-point grading scale in patients undergoing correction of nasolabial folds with a collagen implant. Dermatol Surg. 2010; 36:Suppl 3. 1809–1816.
Article
12. Edsman K, Nord LI, Ohrlund A, Larkner H, Kenne AH. Gel properties of hyaluronic acid dermal fillers. Dermatol Surg. 2012; 38:1170–1179.
Article
13. Falcone SJ, Berg RA. Crosslinked hyaluronic acid dermal fillers: a comparison of rheological properties. J Biomed Mater Res A. 2008; 87:264–271.
Article
14. Kablik J, Monheit GD, Yu L, Chang G, Gershkovich J. Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg. 2009; 35:Suppl 1. 302–312.
Article
15. England MD, Cavarocchi NC, O'brien JF, Solis E, Pluth JR, Orszulak TA, et al. Influence of antioxidants (mannitol and allopurinol) on oxygen free radical generation during and after cardiopulmonary bypass. Circulation. 1986; 74:III134–III137.
16. Weinbroum AA. Mannitol prevents acute lung injury after pancreas ischemia-reperfusion: a dose-response, ex vivo study. Lung. 2009; 187:215–224.
Article
17. Liu JH, Wann H, Chen MM, Pan WH, Chen YC, Liu CM, et al. Baicalein significantly protects human retinal pigment epithelium cells against H2O2-induced oxidative stress by scavenging reactive oxygen species and downregulating the expression of matrix metalloproteinase-9 and vascular endothelial growth factor. J Ocul Pharmacol Ther. 2010; 26:421–429.
Article
18. Khoury W, Namnesnikov M, Fedorov D, Abu-Gazala S, Weinbroum AA. Mannitol attenuates kidney damage induced by xanthine oxidase-associated pancreas ischemia-reperfusion. J Surg Res. 2010; 160:163–168.
Article
19. Belda JI, Artola A, Garcia-Manzanares MD, Ferrer C, Haroun HE, Hassanein A, et al. Hyaluronic acid combined with mannitol to improve protection against free-radical endothelial damage: experimental model. J Cataract Refract Surg. 2005; 31:1213–1218.
Article
20. Baspeyras M, Rouvrais C, Liegard L, Delalleau A, Letellier S, Bacle I, et al. Clinical and biometrological efficacy of a hyaluronic acid-based mesotherapy product: a randomised controlled study. Arch Dermatol Res. 2013; 305:673–682.
Article
21. Taieb M, Gay C, Sebban S, Secnazi P. Hyaluronic acid plus mannitol treatment for improved skin hydration and elasticity. J Cosmet Dermatol. 2012; 11:87–92.
Article
22. Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001; 108:1735–1750. discussion 1751-1752.
Article
Full Text Links
  • AD
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr