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J Cosmet Med 2023; 7(2): 88-93

Published online December 31, 2023

https://doi.org/10.25056/JCM.2023.7.2.88

New method to immediate reconstitute Sculptra to create a more homogenous mixture for immediate use in year 2023

Arthur Yu, MBBS (HK)1 , Cheuk Hung Lee, MBBS (HK), FHKAM (MED), FHKCP, MScPD (Cardiff), MRCP (UK), DPD (Wales), DipDerm (Glasgow), PGDipClinDerm (London), MRCP (London), GradDipDerm (NUS), DipMed (CUHK)2 , Kar Wai Alvin Lee, MBChB (CUHK), DCH (Sydney), Dip Derm (Glasgow), MScClinDerm (Cardiff), MScPD (Cardiff), DipMed (CUHK), DCH (Sydney)2 , Lisa Kwin Wah Chan, MBChB (CUHK), MScPD (Cardiff), PgDipPD (Cardiff), PGDipClinDerm (Lond), DipMed (CUHK), DCH (Sydney)2

1Lightmac, Hong Kong
2Ever Keen Medical Centre, Hong Kong

Correspondence to :
Kar Wai Alvin Lee
E-mail: alvin429@yahoo.com

Received: May 19, 2023; Revised: May 28, 2023; Accepted: May 31, 2023

© Korean Society of Korean Cosmetic Surgery & Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: To create a sterile, non-pyrogenic solution, Sculptra must first be reconstituted with 5 ml sterile water for injection. This reconstitution process has evolved, has become the norm, and has been recommended for use across the globe since it was marketed to the public for aesthetic reasons. The granuloma formation problem of Sculptra Aesthetic is troublesome to some injectors. It can appear anywhere that you injected and is erratic. According to some patients, the inappropriate mixing of Sculptra microparticles with sterile water or the inability of the microparticles to fully dissolve into the solution are to blame for the development of granulomas.
Objective: This article aimed to demonstrate a new reconstitution method (with images) for mixing Sculptra with normal saline.
Methods: In the new reconstitution method, we attached a 21G sterile needle to a sterile, single-use 5 ml syringe. Thereafter, we withdrew 2.5 ml normal saline into the 5 ml syringe. The 21G sterile needle was then introduced into the stopper of the vial, and we slowly added all normal saline into the vial. The vial was shaken vigorously to ensure the full hydration of the content. After shaking, the physician could then add any volume of normal saline.
Results: A homogenous mixture of Sculptra can be achieved using this new reconstitution method. The mixture is ready to use after the immediate reconstitution of Sculptra.
Conclusion: This novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

Keywords: carboxymethylcellulose sodium, granuloma, injections, lactic acid, pain, New-fill

Fig. 1.Normal saline (2.5 ml) injected into a new vial of Sculptra (the Sculptra vial in the image is the old packaging).
  1. Galderma. A patient’s guide to treatment with Sculptra® [Internet]. Fort Worth (TX): Galderma; c2021 [cited 2023 Oct 20].
    Available from: https://www.galderma.com/us/sites/default/files/2021-12/Patient_Brochure_Sculptra_US_1.pdf
  2. Humble G, Mest D. Soft tissue augmentation using Sculptra. Facial Plast Surg 2004;20:157-63.
    Pubmed CrossRef
  3. Vleggaar D, Bauer U. Facial enhancement and the European experience with Sculptra (poly-l-lactic acid). J Drugs Dermatol 2004;3:542-7.
  4. Swift R. Mini vortex mixer: a simple way to prevent Sculptra needle clogging. Plast Reconstr Surg 2015;136:407e-408e.
    Pubmed CrossRef
  5. Bravo BSF, Carvalho RM. Safety in immediate reconstitution of poly-l-lactic acid for facial biostimulation treatment. J Cosmet Dermatol 2021;20:1435-8.
    Pubmed CrossRef
  6. Tagle JM, Macchetto PC, Durán Páramo RM. Clinical performance of a dermal filler containing natural glycolic acid and a polylactic acid polymer: results of a clinical trial in human immunodeficiency virus subjects with facial lipoatrophy. J Clin Aesthet Dermatol 2010;3:42-7.
  7. Hyun MY, Lee Y, No YA, Yoo KH, Kim MN, Hong CK, et al. Efficacy and safety of injection with poly-l-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study. Clin Exp Dermatol 2015;40:129-35.
    Pubmed CrossRef
  8. Keller JD. Sodium carboxymethylcellulose (CMC). In: Glicksman M, editor. Food hydrocolloids. Boca Raton (FL): CRC Press; 1986. p. 43-109.
    KoreaMed CrossRef
  9. Barck M, Stenius P. Interactions between carboxymethyl cellulose and cationic surfactants 1. Phase equilibria and surface tensions. Colloids Surf A Physicochem Eng 1994;89:59-69.
    CrossRef
  10. Arancibia C, Navarro-Lisboa R, Zúñiga RN, Matiacevich S. Application of CMC as thickener on nanoemulsions based on olive oil: physical properties and stability. Int J Polym Sci 2016:6280581.
    CrossRef
  11. Mercadante S, Porzio G, Ferrera P, author, author, author, et al. Pain induced by subcutaneous injections of sterile water, normal saline and local anaesthetics. J Pain Symptom Manage 2001;21:310-4.

Article

How We Do It

J Cosmet Med 2023; 7(2): 88-93

Published online December 31, 2023 https://doi.org/10.25056/JCM.2023.7.2.88

Copyright © Korean Society of Korean Cosmetic Surgery & Medicine.

New method to immediate reconstitute Sculptra to create a more homogenous mixture for immediate use in year 2023

Arthur Yu, MBBS (HK)1 , Cheuk Hung Lee, MBBS (HK), FHKAM (MED), FHKCP, MScPD (Cardiff), MRCP (UK), DPD (Wales), DipDerm (Glasgow), PGDipClinDerm (London), MRCP (London), GradDipDerm (NUS), DipMed (CUHK)2 , Kar Wai Alvin Lee, MBChB (CUHK), DCH (Sydney), Dip Derm (Glasgow), MScClinDerm (Cardiff), MScPD (Cardiff), DipMed (CUHK), DCH (Sydney)2 , Lisa Kwin Wah Chan, MBChB (CUHK), MScPD (Cardiff), PgDipPD (Cardiff), PGDipClinDerm (Lond), DipMed (CUHK), DCH (Sydney)2

1Lightmac, Hong Kong
2Ever Keen Medical Centre, Hong Kong

Correspondence to:Kar Wai Alvin Lee
E-mail: alvin429@yahoo.com

Received: May 19, 2023; Revised: May 28, 2023; Accepted: May 31, 2023

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: To create a sterile, non-pyrogenic solution, Sculptra must first be reconstituted with 5 ml sterile water for injection. This reconstitution process has evolved, has become the norm, and has been recommended for use across the globe since it was marketed to the public for aesthetic reasons. The granuloma formation problem of Sculptra Aesthetic is troublesome to some injectors. It can appear anywhere that you injected and is erratic. According to some patients, the inappropriate mixing of Sculptra microparticles with sterile water or the inability of the microparticles to fully dissolve into the solution are to blame for the development of granulomas.
Objective: This article aimed to demonstrate a new reconstitution method (with images) for mixing Sculptra with normal saline.
Methods: In the new reconstitution method, we attached a 21G sterile needle to a sterile, single-use 5 ml syringe. Thereafter, we withdrew 2.5 ml normal saline into the 5 ml syringe. The 21G sterile needle was then introduced into the stopper of the vial, and we slowly added all normal saline into the vial. The vial was shaken vigorously to ensure the full hydration of the content. After shaking, the physician could then add any volume of normal saline.
Results: A homogenous mixture of Sculptra can be achieved using this new reconstitution method. The mixture is ready to use after the immediate reconstitution of Sculptra.
Conclusion: This novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

Keywords: carboxymethylcellulose sodium, granuloma, injections, lactic acid, pain, New-fill

Fig 1.

Figure 1.Normal saline (2.5 ml) injected into a new vial of Sculptra (the Sculptra vial in the image is the old packaging).
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

References

  1. Galderma. A patient’s guide to treatment with Sculptra® [Internet]. Fort Worth (TX): Galderma; c2021 [cited 2023 Oct 20]. Available from: https://www.galderma.com/us/sites/default/files/2021-12/Patient_Brochure_Sculptra_US_1.pdf
  2. Humble G, Mest D. Soft tissue augmentation using Sculptra. Facial Plast Surg 2004;20:157-63.
    Pubmed CrossRef
  3. Vleggaar D, Bauer U. Facial enhancement and the European experience with Sculptra (poly-l-lactic acid). J Drugs Dermatol 2004;3:542-7.
  4. Swift R. Mini vortex mixer: a simple way to prevent Sculptra needle clogging. Plast Reconstr Surg 2015;136:407e-408e.
    Pubmed CrossRef
  5. Bravo BSF, Carvalho RM. Safety in immediate reconstitution of poly-l-lactic acid for facial biostimulation treatment. J Cosmet Dermatol 2021;20:1435-8.
    Pubmed CrossRef
  6. Tagle JM, Macchetto PC, Durán Páramo RM. Clinical performance of a dermal filler containing natural glycolic acid and a polylactic acid polymer: results of a clinical trial in human immunodeficiency virus subjects with facial lipoatrophy. J Clin Aesthet Dermatol 2010;3:42-7.
  7. Hyun MY, Lee Y, No YA, Yoo KH, Kim MN, Hong CK, et al. Efficacy and safety of injection with poly-l-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study. Clin Exp Dermatol 2015;40:129-35.
    Pubmed CrossRef
  8. Keller JD. Sodium carboxymethylcellulose (CMC). In: Glicksman M, editor. Food hydrocolloids. Boca Raton (FL): CRC Press; 1986. p. 43-109.
    KoreaMed CrossRef
  9. Barck M, Stenius P. Interactions between carboxymethyl cellulose and cationic surfactants 1. Phase equilibria and surface tensions. Colloids Surf A Physicochem Eng 1994;89:59-69.
    CrossRef
  10. Arancibia C, Navarro-Lisboa R, Zúñiga RN, Matiacevich S. Application of CMC as thickener on nanoemulsions based on olive oil: physical properties and stability. Int J Polym Sci 2016:6280581.
    CrossRef
  11. Mercadante S, Porzio G, Ferrera P, author, author, author, et al. Pain induced by subcutaneous injections of sterile water, normal saline and local anaesthetics. J Pain Symptom Manage 2001;21:310-4.

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