Clinical trial NCT05239117 - References

Lipodystrophy — Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects

Citation(s)

•   Ascher B, Bayerl C, Brun P, Kestemont P, Rzany B, Poncet M, Guennoun M, Podda M
  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 Jun;10(2):94-8. doi: 10.1111/j.1473-2165.2011.00550.x.
•   Barnes LA, Marshall CD, Leavitt T, Hu MS, Moore AL, Gonzalez JG, Longaker MT, Gurtner GC
  Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):47-56. doi: 10.1089/wound.2016.0709. Review.
•   Beasley KL, Weiss MA, Weiss RA
  Hyaluronic acid fillers: a comprehensive review. Facial Plast Surg. 2009 May;25(2):86-94. doi: 10.1055/s-0029-1220647. Epub 2009 May 4. Review.
•   Bhatt A
  Protocol deviation and violation. Perspect Clin Res. 2012 Jul;3(3):117. doi: 10.4103/2229-3485.100663.
•   Bogdan Allemann I, Baumann L
  Hyaluronic acid gel (Juvéderm) preparations in the treatment of facial wrinkles and folds. Clin Interv Aging. 2008;3(4):629-34. Review.
•   Brandt FS, Cazzaniga A
  Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. Review.
•   Bukhari SNA, Roswandi NL, Waqas M, Habib H, Hussain F, Khan S, Sohail M, Ramli NA, Thu HE, Hussain Z
  Hyaluronic acid, a promising skin rejuvenating biomedicine: A review of recent updates and pre-clinical and clinical investigations on cosmetic and nutricosmetic effects. Int J Biol Macromol. 2018 Dec;120(Pt B):1682-1695. doi: 10.1016/j.ijbiomac.2018.09.188. Epub 2018 Oct 1. Review.
•   Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD
  Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.
•   Chen WY, Abatangelo G
  Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. Review.
•   De Boulle K, Heydenrych I
  Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin Cosmet Investig Dermatol. 2015 Apr 15;8:205-14. doi: 10.2147/CCID.S80446. eCollection 2015. Review.
•   Dong J, Gantz M, Goldenberg G
  Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313. Review.
•   Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP
  The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7.
•   Eming SA, Martin P, Tomic-Canic M
  Wound repair and regeneration: mechanisms, signaling, and translation. Sci Transl Med. 2014 Dec 3;6(265):265sr6. doi: 10.1126/scitranslmed.3009337. Review.
•   Fakhari A, Berkland C
  Applications and emerging trends of hyaluronic acid in tissue engineering, as a dermal filler and in osteoarthritis treatment. Acta Biomater. 2013 Jul;9(7):7081-92. doi: 10.1016/j.actbio.2013.03.005. Epub 2013 Mar 15. Review.
•   Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK
  A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.
•   Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM
  Update on facial aging. Aesthet Surg J. 2010 Jul-Aug;30 Suppl:11S-24S. doi: 10.1177/1090820X10378696. Review.
•   Freedberg et al
  Fitzpatrick's Dermatology In General Medicine (Two Vol. Set) 6th edition (May 23, 2003
•   Funt D, Pavicic T
  Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Plast Surg Nurs. 2015 Jan-Mar;35(1):13-32. doi: 10.1097/PSN.0000000000000087.
•   Ghooi RB, Bhosale N, Wadhwani R, Divate P, Divate U
  Assessment and classification of protocol deviations. Perspect Clin Res. 2016 Jul-Sep;7(3):132-6. doi: 10.4103/2229-3485.184817.
•   Grablowitz D, Ivezic-Schoenfeld Z, Federspiel IG, Gehl B, Kopera D, Prinz M
  Long-term effectiveness of a hyaluronic acid soft tissue filler in patients with facial lipoatrophy, morphological asymmetry, or debilitating scars. J Cosmet Dermatol. 2020 Oct;19(10):2536-2541. doi: 10.1111/jocd.13454. Epub 2020 Jun 22.
•   Jiang LI, Stephens TJ, Goodman R
  SWIRL, a clinically validated, objective, and quantitative method for facial wrinkle assessment. Skin Res Technol. 2013 Nov;19(4):492-8. doi: 10.1111/srt.12073. Epub 2013 Jun 10.
•   Kim BW, Moon IJ, Yun WJ, Chung BY, Kim SD, Lee GY, Chang SE
  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. Ann Dermatol. 2016 Jun;28(3):297-303. doi: 10.5021/ad.2016.28.3.297. Epub 2016 May 25.
•   Kim JH, Kwon TR, Lee SE, Jang YN, Han HS, Mun SK, Kim BJ
  Comparative Evaluation of the Effectiveness of Novel Hyaluronic Acid-Polynucleotide Complex Dermal Filler. Sci Rep. 2020 Mar 20;10(1):5127. doi: 10.1038/s41598-020-61952-w.
•   Kopera D, Ivezic-Schoenfeld Z, Federspiel IG, Grablowitz D, Gehl B, Prinz M
  Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess(®) FILLER. Clin Cosmet Investig Dermatol. 2018 Nov 27;11:621-628. doi: 10.2147/CCID.S181964. eCollection 2018.
•   Kopera D, Palatin M, Bartsch R, Bartsch K, O'Rourke M, Höller 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. Epub 2015 Mar 3.
•   Kühne U, Esmann J, von Heimburg D, Imhof M, Weissenberger P, Sattler G
  Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study. Clin Cosmet Investig Dermatol. 2016 Oct 20;9:373-381. eCollection 2016.
•   Laurent TC, Fraser JR
  Hyaluronan. FASEB J. 1992 Apr;6(7):2397-404. Review.
•   Lemperle G, Holmes RE, Cohen SR, Lemperle SM
  A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2.
•   Mashiko T, Kinoshita K, Kanayama K, Feng J, Yoshimura K
  Perpendicular Strut Injection of Hyaluronic Acid Filler for Deep Wrinkles. Plast Reconstr Surg Glob Open. 2015 Dec 9;3(11):e567. doi: 10.1097/GOX.0000000000000552. eCollection 2015 Nov.
•   McCall-Perez F, Stephens TJ, Herndon JH Jr
  Efficacy and tolerability of a facial serum for fine lines, wrinkles, and photodamaged skin. J Clin Aesthet Dermatol. 2011 Jul;4(7):51-4.
•   Park KY, Seok J, Rho NK, Kim BJ, Kim MN
  Long-chain polynucleotide filler for skin rejuvenation: efficacy and complications in five patients. Dermatol Ther. 2016 Jan-Feb;29(1):37-40. doi: 10.1111/dth.12299. Epub 2015 Nov 2.
•   Poetschke J, Gauglitz GG
  Current options for the treatment of pathological scarring. J Dtsch Dermatol Ges. 2016 May;14(5):467-77. doi: 10.1111/ddg.13027. Review.
•   Rippa AL, Kalabusheva EP, Vorotelyak EA
  Regeneration of Dermis: Scarring and Cells Involved. Cells. 2019 Jun 18;8(6). pii: E607. doi: 10.3390/cells8060607. Review.
•   Rivkin AZ
  Volume correction in the aging hand: role of dermal fillers. Clin Cosmet Investig Dermatol. 2016 Aug 30;9:225-32. doi: 10.2147/CCID.S92853. eCollection 2016.
•   Rumsey N
  Psychosocial adjustment to skin conditions resulting in visible difference (disfigurement): What do we know? Why don't we know more? How shall we move forward? Int J Womens Dermatol. 2017 Dec 15;4(1):2-7. doi: 10.1016/j.ijwd.2017.09.005. eCollection 2018 Mar. Review.
•   Rzany B, Cartier H, Kestemont P, Trevidic P, Sattler G, Kerrouche N, Dhuin JC, Ma YM
  Full-face rejuvenation using a range of hyaluronic acid fillers: efficacy, safety, and patient satisfaction over 6 months. Dermatol Surg. 2012 Jul;38(7 Pt 2):1153-61. doi: 10.1111/j.1524-4725.2012.02470.x.
•   Savoia A
  , Onori N., Bladi A., Efficacy of Skinfill plus filler in the management of facial aging: a multicenter, post-marketing clinical study, Biomedical Dermatology volume 2, Article number: 2 (2018).
•   Stephens TJ, Sigler ML, Herndon JH Jr, Dispensa L, Le Moigne A
  A placebo-controlled, double-blind clinical trial to evaluate the efficacy of Imedeen(®) Time Perfection(®) for improving the appearance of photodamaged skin. Clin Cosmet Investig Dermatol. 2016 Mar 15;9:63-70. doi: 10.2147/CCID.S98787. eCollection 2016.
•   Sudha PN, Rose MH
  Beneficial effects of hyaluronic acid. Adv Food Nutr Res. 2014;72:137-176. doi: 10.1016/B978-0-12-800269-8.00009-9. Review.
•   van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP
  Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22.
•   Van Dyke S, Hays GP, Caglia AE, Caglia M
  Severe Acute Local Reactions to a Hyaluronic Acid-derived Dermal Filler. J Clin Aesthet Dermatol. 2010 May;3(5):32-5.
•   van Eijk T, Braun M
  A novel method to inject hyaluronic acid: the Fern Pattern Technique. J Drugs Dermatol. 2007 Aug;6(8):805-8.
•   Zaleski-Larsen LA, Fabi SG, McGraw T, Taylor M
  Acne Scar Treatment: A Multimodality Approach Tailored to Scar Type. Dermatol Surg. 2016 May;42 Suppl 2:S139-49. doi: 10.1097/DSS.0000000000000746. Review.

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerised Polynucleotides Dermal Filler) in the Treatment of Dermal Tissue Defects

Details for clinical trial NCT05239117