Case Study


Case report of 45-weeks safety data of five patients after receiving Hyaluronic Acid Fillers, Botulinum Toxin and Poly-L-Lactic Acid in a single session

(NACH CARE-LEITLINIE)

Keywords | Summary | Correspondence | Literature


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Summary

An aesthetic full-face treatment with three classes of injectables (neuromodulators, hyaluronic acid, and biostimulators) in one session is a desired therapy for some patients. While therapies using one or two classes of injectables in a single treatment session are relatively well established, safety data on a threefold combination therapy in a single session has yet to be described. Here, we present a case report with 45-week safety data for five patients who received threefold combination therapy. Although the results indicate no additional risk, clinical studies with a larger group of patients are required to make a solid statement.

Zusammenfassung

Eine ästhetische Ganzgesichtsbehandlung mit drei Klassen von Injektionsmitteln (Neuromodulatoren, Hyaluronsäure und Biostimulatoren) in einer Sitzung ist für einige Patienten eine gewünschte Therapie. Während Therapien mit einer oder zwei Klassen von Injektionsmitteln in einer einzigen Behandlungssitzung relativ gut etabliert sind, wurden bisher noch keine Sicherheitsdaten zu einer dreifachen Kombinationstherapie in einer einzigen Sitzung beschrieben. Hier stellen wir einen Fallbericht mit 45-wöchigen Sicherheitsdaten für fünf Patienten vor, die eine Dreifach-Kombinationstherapie erhielten. Obwohl die Ergebnisse auf kein zusätzliches Risiko hindeuten, sind klinische Studien mit einer größeren Gruppe von Patienten erforderlich, um eine solide Aussage zu treffen.


Roland Mett1, Ola Wilaszek1, Jacqueline Karger1, Stas Wüst2

 

1 Helios Kliniken Schwerin GmbH
Plastische- und Ästhetische- Chirurgie
Rekonstruktives Brustzentrum

2 Z282 Medical Affairs Consulting

 

During a routine training session with plastic and aesthetic surgeon assistant physicians, five patients (age range 53-65 years) underwent a full-face minimally invasive rejuvenation treatment. Each patient received a combination therapy of poly-L-lactic acid (PLLA; Sculptra®, Galderma), hyaluronic acid (HA) fillers (Restylane® VOLYME™, Restylane® LYFT™, Restylane® KYSSE™, Galderma; Volbella®, Juvéderm®), and AbobotulinumtoxinA (BoNT-A, Azzalure®/Dysport®, Galderma) in a single session. One patient was additionally treated with HA skin boosters (Restylane® Skinboosters™ VITAL, Galderma). Botulinum toxin was used for the treatment of ‚bunny lines‘, glabellar lines, horizontal forehead lines, lateral canthal lines and to lift the eyebrows. Hyaluronic acid fillers were used on the cheeks, jowls, marionette lines, nasolabial fold, and upper lip. Jowls and jawline were treated with PLLA (Sculptra®, Galderma). According to the manufacturers’ recommendations and local approval, an injection of PLLA in hyperdynamic regions, as well as an injection of PLLA and HA in the same region and plane, were strongly avoided.

 

Although the products used in this report have a good safety profile on their own (based on the corresponding information of use), and some approaches using BoNT-A, HA-fillers/skin boosters, and biostimulators in different combinations have been previously described as safe [1, 2, 3, 4, 5], no published data on late onset of adverse events (up to 45 weeks) or cross-reactivity of the presented single-session triple-therapy is known to the authors.

 

This report focuses on the safety data of full-face treatment with three different injectables in a single session, strictly avoiding product overlap in the treated areas. All patients were female and underwent surgical procedures in the past five years. Medical histories of the patients include the following: one patient received chemotherapy, one patient reported migraine and penicillin/gabapentin allergy, one patient was suffering from morbus Basedow, morbus Manière, endocrine orbitopathy, and nicotine dependence, and one patient underwent a hemithyroidectomy. The specifics of the treatments and the patients‘ medical histories are listed in Table 1.

 

At the moment of the treatment, all patients were in good health and without signs of contraindications from the treatment. Directly after the treatment, one patient reported injection site pain, and one patient showed a small bleeding at the injection site. Both adverse events were related to botulinum toxin treatment. No moderate or severe adverse events were reported at the doctor’s office. The patients were socially acceptable directly after the treatment. No adverse events were reported 45 weeks past the treatment.

 

Although this initial report uses a very small number of patients, it provides a first hint that the combinational therapy of BoNT-A, hyaluronic acid fillers, and PLLA in one consecutive session is a safe and well-tolerable procedure. Even the patients with a controlled immune disorder reported no long-term adverse events. However, it is imperative that the injector strictly avoids overlap of the treated areas and is precise with the plane of injection. To create solid evidence for a threefold combinational therapy, clinical studies including larger numbers of patients are necessary.

 

Conflict of interest
SW is a consultant for Galderma Laboratorium GmbH, Germany.

 

Authors Contribution
RM selected the patients, supervised the treatment, provided medical and scientific advice for the manuscript. OW, JK collected and evaluated the data. RM, SW, OW analyzed the data. SW provided scientific advice and wrote the manuscript.

 

Informed consent statement
Written informed consent from the patients for the use of data and publication of their case details has been obtained by the authors.

Screenshot

Korrespondenz-Adresse

Dr.med. Roland Mett
Helios Kliniken Schwerin GmbH
Plastische- und Ästhetische- Chirurgie
Rekonstruktives Brustzentrum
Wismarsche Straße 393-397
DE-19055 Schwerin
roland.mett@helios-gesundheit.de

Literatur

1. Hedén P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and safe repeated full-face treatments with abobotulinumtoxin A, hyaluronic acid filler, and skin boosting hyaluronic acid. J Drugs Dermatol. 2019; 18(7): 682-689. PMID: 31334927.
2. Guarnieri Munia C, Morais M, Sato M, Parada M, Avelar LE. Optimizing skin quality with injectable poly-l-lactic acid and hyaluronic acid. J Clin Aesthet Dermatol. 2023 16(6): 26-29. PMID: 37361359; PMCID: PMC10286875.
3. Lorenc ZP, Daro-Kaftan E. Optimizing facial rejuvenation outcomes by combining poly-L-lactic acid, hyaluronic acid, calcium hydroxylapatite, and neurotoxins: two case studies. J Drugs Dermatol. 2014 Feb;13(2):191-5. PMID: 24509971.
4. Cartier H, Hedén P, Delmar H, Bergentz P, Skoglund C, Edwartz C, Norberg M, Kestemont P. Repeated full-face aesthetic combination treatment with abobotulinumtoxin A, hyaluronic acid filler, and skin-boosting hyaluronic acid after monotherapy with abobotulinumtoxin A or hyaluronic acid filler. Dermatol Surg. 2020 46(4): 475-482. doi: 10.1097/DSS.0000000000002165. PMID: 31592825; PMCID: PMC7147415.
5. Molina B, David M, Jain R, Amselem M, Ruiz-Rodriguez R, Ma MY, Kerrouche N, Georgantopoulos SP, Radeau T, Boineau D. Patient satisfaction and efficacy of full-facial rejuvenation using a combination of botulinum toxin type A and hyaluronic acid filler. Dermatol Surg. 2015;41 Suppl 1: S325-32. doi: 10.1097/DSS.0000000000000548. PMID: 26618460.

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