A randomized, double-blind, comparative study for efficacy assessment of two hyaluronic acid nasolabial fillers
Abstract
Hyaluronic acid fillers are considered safe for use in cosmetics as described in the safety assessment. This study was aimed to assess and compare the efficacy and safety of two hyaluronic acid (HA) fillers on mild nasolabial folds. Ten women aged 30-50 years with mild nasolabial folds participated for injection of A and B gels into right or left nasolabial folds. The volume and surface of nasolabial folds were measured by CSI software and the density and thickness of dermis assessed by skin ultrasonography before and 2, 12, and 24 weeks after injection. The data were analyzed using SPSS software version 20, and p-value <0.05 were considered as significant. Global assessment showed over 50% improvement in patients injected with both gel A and B. At 2 weeks after injecting gel A the volume and surface of wrinkles decreased significantly. In the side injected with gel B, this reduction was significant at 2 and 12 weeks after injection. In addition, 24 weeks after injection of both gels the dermis echo-density increased and the dermis thickness decreased. This study indicated the significant positive filling effect of both HA fillers in decreasing the clinical signs of wrinkles at nasolabial folds. Comparing both fillers, there were not any statistically significant differences in any of measurements, but the persistence of gel B to improve the wrinkle appearance was slightly better than gel A.
References
Stern R, Maibach HI. Hyaluronan in skin: aspects of aging and its pharmacologic modulation. Clin Dermatol 2008; 26(2): 106-122. doi: 10.1016/j.clindermatol.2007.09.013.
Fisher GJ, Varani J, Voorhees JJ. Looking older: Fibroblast collapse and therapeutic implications. Arch Dermatol 2008; 144(5): 666-672. doi: 10.1001/archderm.144.5.666.
Bailey AJ. Molecular mechanisms of ageing in connective tissues. Mech Ageing Dev 2001; 122(7): 735-755. doi: 10.1016/S0047-6374(01)00225-1.
Masson F. Skin hydration and hyaluronic acid. Ann Dermatol Venereol. 2010; 137(Suppl 1):S23-25. doi: 10.1016/S0151-9638(10)70005-3.
Lupo MP. Hyaluronic acid fillers in facial rejuvenation. Semin Cutan Med Surg. 2006; 25: 122-126. doi: 10.1016/j.sder.2006.06.011.
Walter RJ, Matsuda T, Reyes HM, Walter JM, Hanumadass M. Characterization of acellular dermal matrices (ADMs) prepared by two different methods. Burns 1998; 24(2): 104-113. doi: 10.1016/S0305-4179(97)00110-1.
Ascher B, Cerceau M, Baspeyras M, Rossi B. Soft tissue filling with hyaluronic acid. Ann Chir Plast Esthet 2004; 49(5): 465-685. doi: 10.1016/j.anplas.2004.09.001.
Choi YJ, Lee JY, Ahn JY, Kim MN, Park MY. The safety and efficacy of a combined diode laser and bipolar radiofrequency compared with combined infrared light and bipolar radiofrequency for skin rejuvenation. Indian J Dermatol Venereol Leprol 2012; 78(2): 146-152. doi: 10.4103/0378-6323.93630.
Dreno B, Araviiskaia E, Berardesca E, Bieber T, Hawk J, Sanchez-Viera M, et al. The science of dermocosmetics and its role in dermatology. J Eur Acad Dermatol Venereol 2014; 28(11): 1409-1417. doi: 10.1111/jdv.12497.
Reips UD, Funke F. Interval level measurement with visual analogue scales in Internet-based research: VAS Generator. Behav Res Methods 2008; 40(3): 699-704. doi: 10.3758/BRM.40.3.699.
Monstrey SJ, Pitaru S, Hamdi M, Van Landuyt K, Blondeel P, Shiri J, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007; 120(1): 303-311. doi: 10.1097/01.prs.0000264402.97692.b6.
Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, et al. A randomized study of the efficacy and safety of injectable poly L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol 2010; 62(3): 448-462. doi: 10.1016/j.jaad.2009.07.040.
Sales AG, Lotierzo PH, Gimenez R, Camargo CP, Ferreira MC. Evaluation of poly-L-lactic acid implant for treatment of the nasolabial fold: 3-year follow-up evaluation. Aesthetic Plast. Surg 2008; 32(5): 753-756. doi: 10.1007/s00266-008-9182-2.
Baumann LS, Shamban AT, Lupo MP, Monheit GD, Thomas JA, Murphy DK, et al. Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study. Dermatol Surg 2007; 33(2): S128-35. doi: 10.1097/00042728-200712001-00004.
Croce MA, Dyne K, Boraldi F, Quaglino D Jr, Cetta G, Tiozzo R, et al. Hyaluronan affects protein and collagen synthesis by in vitro human skin fibroblasts. Tissue & Cell 2001; 33(4): 326-331. doi: 10.1054/tice.2001.0180.
Kim J. Effects of Injection Depth and Volume of Stabilized Hyaluronic Acid in Human Dermis on Skin Texture, Hydration, and Thickness. Arch Aesthetic Plast Surg 2014; 20(2): 97-103. doi: 10.14730/aaps.2014.20.2.97.
Dranitsaris G, Dorward K, Hatzimichael E, Amir E. Clinical trial design in biosimilar drug development. Invest New Drugs 2013; 31(2): 479-487. doi: 10.1007/s10637-012-9899-2.
Copyright (c) 2022 Saman Ahmad Nasrollahi, Mansour Nassiri Kashani, Taraneh Yazdanparast, Setareh Ameri, Alireza Firooz
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Author(s) shall retain the copyright of their work and grant the Journal/Publisher rights for the first publication with the work concurrently licensed under the Creative Commons Attribution-Noncommercial 4.0 International License
Under this license, author(s) will allow third parties to download, reuse, reprint, modify, distribute and/or copy the content under the condition that the authors are given credit and that the work is not used for commercial purposes. No permission is required from the authors or the publisher.
This broad license intends to facilitate free access, as well as the unrestricted use of original works of all types. This ensures that the published work is freely and openly available in perpetuity.
