saypha®

Clinical Evidence

Science-backed
confidence

Our commitment to clinical evidence ensures practitioners and patients can trust in the safety and efficacy of every Saypha® product.

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Research & Evidence

Advancing the science of
aesthetic medicine

Safety has been proven in multiple clinical trials.9–19 Headquartered in Austria, Croma has decades of experience in manufacturing, using high-quality raw materials to ensure exceptional production standards and product safety.

16+

Published studies

80+

Countries worldwide

1st

MDR certified filler

Citations

Clinical references

  1. 1.Rzany B, Sulovsky M, Sattler G, Cecerle M, Grablowitz D. Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study. Aesthet Surg J. 2024;44(2):203-215. doi: 10.1093/asj/sjad230. PMID: 37439274; PMCID: PMC10790962. (Since 2018 the product range is named saypha®).
  2. 2.Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135. PMID: 18488885; PMCID: PMC2544360.
  3. 3.Wang F, Garza LA, Kang S, Varani J, Orringer JS, Fisher GJ, Voorhees JJ. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged human skin. Arch Dermatol. 2007 Feb;143(2):155-63. doi: 10.1001/archderm.143.2.155. PMID: 17309996.
  4. 4.saypha® Product Instructions for Use (General).
  5. 5.saypha® FILLER Lidocaine Instructions for Use.
  6. 6.saypha® VOLUME Lidocaine Instructions for Use.
  7. 7.saypha® VOLUME PLUS Lidocaine Instructions for Use.
  8. 8.Data on File, CPH-401-201331.
  9. 9.Grablowitz D, Sulovsky M, Höller S, Ivezic-Schoenfeld Z, Chang-Rodriguez S, Prinz M. Safety And Efficacy Of Princess® FILLER Lidocaine In The Correction Of Nasolabial Folds. Clin Cosmet Investig Dermatol. 2019;12:857-864. doi: 10.2147/CCID.S211544. PMID: 31819583.
  10. 10.Kopera D, Palatin M, Bartsch R, Bartsch K, O'Rourke M, Holler S, Baumgartner RR, Prinz M. An open-label uncontrolled, multicenter study for the evaluation of the efficacy and safety of the dermal filler Princess VOLUME in the treatment of nasolabial folds. Biomed Res Int. 2015;2015:195328. doi: 10.1155/2015/195328. PMID: 25821787.
  11. 11.Stocks D, Sundaram H, Michaels J, Durrani MJ, Wortzman MS, Nelson DB. Rheological evaluation of the physical properties of hyaluronic acid dermal fillers. J Drugs Dermatol. 2011;10(9):974-980. PMID: 22052265.
  12. 12.Smith L, Cockerham K. Hyaluronic acid dermal fillers: can adjunctive lidocaine improve patient satisfaction without decreasing efficacy or duration? Patient Prefer Adherence. 2011;5:133-139. doi: 10.2147/PPA.S11251. PMID: 21448297.
  13. 13.Data on File, Croma-Pharma GmbH.
  14. 14.Data on File, Croma-Pharma GmbH. (Additional data set)
  15. 15.Bogdan Allemann I, Baumann L. Hyaluronic acid gel (Juvéderm) preparations in the treatment of facial wrinkles and folds. Clin Interv Aging. 2008;3(4):629-634. doi: 10.2147/CIA.S3118. PMID: 19281055.
  16. 16.Data on File, BCG Analysis, May 2021. N = 2519.
  17. 17.Kopera D, Ivezic-Schoenfeld Z, Chang-Rodriguez S, Hoeller S, Grablowitz D, Bartsch K, Prinz M. A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds. Dermatol Ther. 2020;33(6):e14310. doi: 10.1111/dth.14310. PMID: 32946162.
  18. 18.Frank K, Downie J, Gold M, Joseph J, Green J, Fabi S, Bank D, Cohen JL, Shamban A, Weiss R, Krames-Juerss A, Monheit G. Multicenter, Randomized Split-Face Trial of a Crosslinked Hyaluronic Acid Filler With Lidocaine for Nasolabial Fold Correction. Aesthet Surg J. 2025;sjaf137. doi: 10.1093/asj/sjaf137. PMID: 40747729.
  19. 19.Frank K, Hilton S, Kerscher M, Grablowitz D, Kopera D, Sulovsky M, Kursinov L. The Safety Profile of a Portfolio of Hyaluronic Acid-Based Soft Tissue Fillers Manufactured Using MACRO Technology: A Systematic Review of Clinical Evidence. Life (Basel). 2026;16(1):110. doi: 10.3390/life16010110. PMID: 41598265.

a Applies to VOLUME PLUS, as shown in the PRIMAvera clinical study. b Applies to VOLUME PLUS, based on clinical study data. c Lidocaine is incorporated in all saypha® Lidocaine products.

For clinical inquiries, please contact admin@renellence.com

Regulatory Information

Health Canada approved

  • Health Canada Medical Device Licence #97305 (saypha® Filler Lidocaine)
  • Manufactured by Croma-Pharma GmbH, Leobendorf, Austria
  • Distributed in Canada by Renellence Inc., 75 Scarsdale Rd, North York, ON
  • Intended for use by licensed healthcare professionals only