Patrick Trevidic
Research Subjects
Patrick Trevidic has a total of 65 co-authors. Here are the top co-authors by number of shared publications:
- Berthold Rzany
Charité – Universitätsmedizin Berlin
3 shared publications - Gerhard Sattler
Rosenparkklinik GmbH, Darmstadt, Germany
3 shared publications Gisella Criollo-Lamilla
Expert2expert Group, Budapest, Hungary
3 shared publicationsHugues Cartier
3 shared publicationsJean-Charles Dhuin
3 shared publicationsNabil Kerrouche
3 shared publications
Latest Publications
- Open Access
- 2 July 2025
- Published by Wolters Kluwer Health in Dermatologic Surgery
- Vol. 52 (1) , 36-40
Creation and Validation of a Photonumeric Scale for Assessment of Midface Volume Deficit
BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the midface volume deficit after treatment with dermal fillers. OBJECTIVE: To develop a midface volume deficit rating scale and establish its reliability and sensitivity for grading subjects in clinical trials and routine practice. METHODS: A 5-grade photonumeric scale was developed by clinical experts based on real-subject photographs and validated through photographic and live subject evaluation. RESULTS: The mean intra-rater weighted Kappa score between the 2 sessions of photographic validation was 0.92. Inter-rater intraclass correlation coefficient (ICC) was 0.89 for the combined sessions. The average intra-rater weighted Kappa score and inter-rater ICC for the live validation reached 0.81 and 0.78, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 80% and 89% of cases, respectively. CONCLUSION: The Teoxane Midface Volume Deficit Scale can measure the degree of volume deficit, detect a clinically meaningful difference of 1-grade, and is applicable to the ethnic diversity of the population. This scale is a repeatable, reproducible clinician-reported outcome and a useful tool for health care providers to classify midface volume depletion both in clinical trials and routine patient care.
- 2 July 2025
- Published by Wolters Kluwer Health in Dermatologic Surgery
- Vol. 52 (1) , 36-40
Open AccessCreation and Validation of a Photonumeric Scale for Assessment of Midface Volume Deficit
BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the midface volume deficit after treatment with dermal fillers. OBJECTIVE: To develop a midface volume deficit rating scale and establish its reliability and sensitivity for grading subjects in clinical trials and routine practice. METHODS: A 5-grade photonumeric scale was developed by clinical experts based on real-subject photographs and validated through photographic and live subject evaluation. RESULTS: The mean intra-rater weighted Kappa score between the 2 sessions of photographic validation was 0.92. Inter-rater intraclass correlation coefficient (ICC) was 0.89 for the combined sessions. The average intra-rater weighted Kappa score and inter-rater ICC for the live validation reached 0.81 and 0.78, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 80% and 89% of cases, respectively. CONCLUSION: The Teoxane Midface Volume Deficit Scale can measure the degree of volume deficit, detect a clinically meaningful difference of 1-grade, and is applicable to the ethnic diversity of the population. This scale is a repeatable, reproducible clinician-reported outcome and a useful tool for health care providers to classify midface volume depletion both in clinical trials and routine patient care.
- 2 June 2025
- Published by Georg Thieme Verlag KG in Facial Plastic Surgery
- Vol. 42 (01) , 146-155
Denervation Neck Lift: An Updated Rhytidectomy Technique and Prospective Follow-Up of 80 Patients
Platysma bands are caused by excessive muscular activity and a novel threefold approach (denervation, platysmaplasty, and skin resection) was developed to minimize recurrence. To investigate the efficacy, tolerability, and satisfaction of this new technique in a larger cohort. A total of 80 patients were included in this prospective descriptive study and followed for 1 year. Surgical platysma transection with intentional denervation was performed simultaneously with a primary rhytidectomy and recurrence, complications, and satisfaction were assessed. Platysma band recurrence occurred in 10% of patients all of whom were >63 years old. There were no major postoperative complications, with a total of 35 minor complications (in 43.7% of patients). Satisfaction scores were high for both patients and the surgeon 1 year after treatment, with Global Aesthetic Improvement Scale scores of 4.64 and 4.54, respectively. This technique was effective and well tolerated, with low rates of recurrence and only minor complications.
- 2 June 2025
- Published by Georg Thieme Verlag KG in Facial Plastic Surgery
- Vol. 42 (01) , 146-155
Denervation Neck Lift: An Updated Rhytidectomy Technique and Prospective Follow-Up of 80 Patients
Platysma bands are caused by excessive muscular activity and a novel threefold approach (denervation, platysmaplasty, and skin resection) was developed to minimize recurrence. To investigate the efficacy, tolerability, and satisfaction of this new technique in a larger cohort. A total of 80 patients were included in this prospective descriptive study and followed for 1 year. Surgical platysma transection with intentional denervation was performed simultaneously with a primary rhytidectomy and recurrence, complications, and satisfaction were assessed. Platysma band recurrence occurred in 10% of patients all of whom were >63 years old. There were no major postoperative complications, with a total of 35 minor complications (in 43.7% of patients). Satisfaction scores were high for both patients and the surgeon 1 year after treatment, with Global Aesthetic Improvement Scale scores of 4.64 and 4.54, respectively. This technique was effective and well tolerated, with low rates of recurrence and only minor complications.
- 26 July 2024
- Published by Elsevier in Annales de Chirurgie Plastique Esthétique
- Vol. 69 (6) , 650-673
Les injections du front : anatomie, techniques, produits
- 26 July 2024
- Published by Elsevier in Annales de Chirurgie Plastique Esthétique
- Vol. 69 (6) , 650-673
Les injections du front : anatomie, techniques, produits
- Open Access
- 3 July 2023
- Published by Wolters Kluwer Health in Dermatologic Surgery
- Vol. 49 (8) , 777-782
Creation and Validation of a Photonumeric Scale for Assessment of Infraorbital Hollows
BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers. OBJECTIVE: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice. METHODS AND MATERIALS: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreements during the TIOHS validation were excellent. The mean intrarater-weighted Kappa score between the 2 sessions of photographic validation was 0.92, while inter-rater interclass correlation coefficient (ICC) was 0.92 for the combined sessions. The average intrarater-weighted Kappa score and inter-rater ICC for the live validation reached 0.80 and 0.76, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 82% and 86% of cases, respectively. CONCLUSION: The intrarater Kappa scores and inter-rater ICCs met their predetermined acceptance criteria of >0.70. The TIOHS is a repeatable and reproducible clinician-reported outcome for health care providers to classify IOHs in clinical trials and routine patient care. A 1-grade difference on the TIOHS can detect a clinically meaningful difference in infraorbital hollowing.
- 3 July 2023
- Published by Wolters Kluwer Health in Dermatologic Surgery
- Vol. 49 (8) , 777-782
Open AccessCreation and Validation of a Photonumeric Scale for Assessment of Infraorbital Hollows
BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers. OBJECTIVE: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice. METHODS AND MATERIALS: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreements during the TIOHS validation were excellent. The mean intrarater-weighted Kappa score between the 2 sessions of photographic validation was 0.92, while inter-rater interclass correlation coefficient (ICC) was 0.92 for the combined sessions. The average intrarater-weighted Kappa score and inter-rater ICC for the live validation reached 0.80 and 0.76, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 82% and 86% of cases, respectively. CONCLUSION: The intrarater Kappa scores and inter-rater ICCs met their predetermined acceptance criteria of >0.70. The TIOHS is a repeatable and reproducible clinician-reported outcome for health care providers to classify IOHs in clinical trials and routine patient care. A 1-grade difference on the TIOHS can detect a clinically meaningful difference in infraorbital hollowing.
- Open Access
- 1 April 2023
- Published by Taylor & Francis in Clinical, Cosmetic and Investigational Dermatology
- Vol. ume 16, 959-972
Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study
Purpose: Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF). Patients and Methods: A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs). Results: Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported. Conclusion: RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.
- 1 April 2023
- Published by Taylor & Francis in Clinical, Cosmetic and Investigational Dermatology
- Vol. ume 16, 959-972
Open AccessEfficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study
Purpose: Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF). Patients and Methods: A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs). Results: Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported. Conclusion: RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.
- 5 April 2022
- Published by Wolters Kluwer Health in Plastic and Reconstructive Surgery
- Vol. 149 (6) , 1326-1336
Midface Multilayering Filler Injection Technique: Understanding of the Dynamic Facial Anatomy Through a “Smiling Cadavers” Anatomical Study
Background: Understanding age-related changes in compartmentalized facial fat and their role in facial dynamics and aesthetics is essential to target filler injections for midface rejuvenation. Methods: A novel anatomical approach (“smiling cadavers”) was used to identify the main midface fat compartments involved during muscular contraction when smiling and their motion and behavior with and without filler injections. Based on these insights and the literature, a multilayering filler injection approach was developed to optimize midface rejuvenation by restoring fat volumes using rheologically different products injected into different fat compartments. Results: Twenty-four hemifacial dissections confirmed the presence of two fat compartment layers, separated by the orbicularis oculi muscle in the horizontal plane and by the septa in the vertical plane, and revealed the anatomical effects of facial movement. The midface is composed of deep static fat compartments and a superficial dynamic adipose layer that follows the facial movements, creating a natural dynamic appearance. A proof-of-concept study involved 130 White patients (36 to 56 years; 91 percent women). After the procedure, 95 percent of patients and 98 percent of practitioners rated facial appearance as “improved” or “much/very much improved.” No major complications were reported. Conclusions: The smiling cadavers method enhances understanding of dynamic facial anatomy by showing the superficial and deep fat compartments of the midface at rest and their motion during a procedure to represent a smile. The multilayered injection technique takes into account these anatomical findings to rejuvenate the midface, achieving a natural appearance at rest and during motion.
- 5 April 2022
- Published by Wolters Kluwer Health in Plastic and Reconstructive Surgery
- Vol. 149 (6) , 1326-1336
Midface Multilayering Filler Injection Technique: Understanding of the Dynamic Facial Anatomy Through a “Smiling Cadavers” Anatomical Study
Background: Understanding age-related changes in compartmentalized facial fat and their role in facial dynamics and aesthetics is essential to target filler injections for midface rejuvenation. Methods: A novel anatomical approach (“smiling cadavers”) was used to identify the main midface fat compartments involved during muscular contraction when smiling and their motion and behavior with and without filler injections. Based on these insights and the literature, a multilayering filler injection approach was developed to optimize midface rejuvenation by restoring fat volumes using rheologically different products injected into different fat compartments. Results: Twenty-four hemifacial dissections confirmed the presence of two fat compartment layers, separated by the orbicularis oculi muscle in the horizontal plane and by the septa in the vertical plane, and revealed the anatomical effects of facial movement. The midface is composed of deep static fat compartments and a superficial dynamic adipose layer that follows the facial movements, creating a natural dynamic appearance. A proof-of-concept study involved 130 White patients (36 to 56 years; 91 percent women). After the procedure, 95 percent of patients and 98 percent of practitioners rated facial appearance as “improved” or “much/very much improved.” No major complications were reported. Conclusions: The smiling cadavers method enhances understanding of dynamic facial anatomy by showing the superficial and deep fat compartments of the midface at rest and their motion during a procedure to represent a smile. The multilayered injection technique takes into account these anatomical findings to rejuvenate the midface, achieving a natural appearance at rest and during motion.
- 25 January 2022
- Published by Wolters Kluwer Health in Plastic and Reconstructive Surgery
- Vol. 149 (2) , 384-394
Consensus Recommendations on the Use of Hyaluronic Acid–Based Fillers for Nonsurgical Nasal Augmentation in Asian Patients
Background: Nonsurgical nasal augmentation using dermal fillers such as hyaluronic acid is increasing in popularity because of its less invasive nature and shorter downtime compared with traditional surgery. However, the complexity of the nasal vasculature makes it a high-risk procedure without proper training. Appropriate patient and product selection and safer standardized injection techniques are warranted to minimize complications and to achieve reproducible aesthetic results. In this article, recommendations for nonsurgical nasal augmentation using hyaluronic acid fillers are outlined, with focus on the dorsum, tip, and columella. Methods: A consensus meeting was conducted to develop recommendations on nonsurgical nasal augmentation in Asian patients using hyaluronic acid–based fillers. Literature review was performed using PubMed and Google Scholar. Relevant studies were included to formulate recommendations. Consensus statements were graded using the criteria outlined by the Grading of Recommendations Assessment, Development and Evaluation Working Group. Results: Nonsurgical nasal augmentation is an advanced procedure that warrants in-depth knowledge of the nasal anatomy. The panel recommends thorough preinjection assessment and counseling to fully align the patient’s expectations with aesthetic goals. Injections must be deep and at the level of the periosteum or perichondrium to minimize risk of intravascular injection. Aliquots of hyaluronic acid must be introduced using slow, low-pressure, and low-volume injections. Optimal aesthetic effect is achieved with hyaluronic acid dermal fillers that are highly elastic, cohesive, and with good adaptability to their environment. Conclusions: Hyaluronic acid injections are safe and effective in nonsurgical nasal augmentation. In-depth knowledge of vascular anatomy and proper injection techniques using suitable products are necessary to achieve aesthetic goals safely. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.
- 25 January 2022
- Published by Wolters Kluwer Health in Plastic and Reconstructive Surgery
- Vol. 149 (2) , 384-394
Consensus Recommendations on the Use of Hyaluronic Acid–Based Fillers for Nonsurgical Nasal Augmentation in Asian Patients
Background: Nonsurgical nasal augmentation using dermal fillers such as hyaluronic acid is increasing in popularity because of its less invasive nature and shorter downtime compared with traditional surgery. However, the complexity of the nasal vasculature makes it a high-risk procedure without proper training. Appropriate patient and product selection and safer standardized injection techniques are warranted to minimize complications and to achieve reproducible aesthetic results. In this article, recommendations for nonsurgical nasal augmentation using hyaluronic acid fillers are outlined, with focus on the dorsum, tip, and columella. Methods: A consensus meeting was conducted to develop recommendations on nonsurgical nasal augmentation in Asian patients using hyaluronic acid–based fillers. Literature review was performed using PubMed and Google Scholar. Relevant studies were included to formulate recommendations. Consensus statements were graded using the criteria outlined by the Grading of Recommendations Assessment, Development and Evaluation Working Group. Results: Nonsurgical nasal augmentation is an advanced procedure that warrants in-depth knowledge of the nasal anatomy. The panel recommends thorough preinjection assessment and counseling to fully align the patient’s expectations with aesthetic goals. Injections must be deep and at the level of the periosteum or perichondrium to minimize risk of intravascular injection. Aliquots of hyaluronic acid must be introduced using slow, low-pressure, and low-volume injections. Optimal aesthetic effect is achieved with hyaluronic acid dermal fillers that are highly elastic, cohesive, and with good adaptability to their environment. Conclusions: Hyaluronic acid injections are safe and effective in nonsurgical nasal augmentation. In-depth knowledge of vascular anatomy and proper injection techniques using suitable products are necessary to achieve aesthetic goals safely. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.
- Top Cited PapersOpen Access
- 17 January 2022
- Published by Oxford University Press (OUP) in Aesthetic Surgery Journal
- Vol. 42 (8) , 920-934
Injection Guidelines for Treating Midface Volume Deficiency With Hyaluronic Acid Fillers: The ATP Approach (Anatomy, Techniques, Products)
Midface rejuvenation is among the most valuable indications of hyaluronic acid dermal fillers, because malar projection and full upper cheeks significantly contribute to a youthful appearance. Hyaluronic acid fillers have evolved over the past 2 decades to meet specific clinical needs such as strong projection capacity and adaptability to facial dynamism. As a result, they now represent the treatment of choice for midface rejuvenation throughout age ranges by offering the potential for noninvasive treatment, immediate results, and minimal downtime. Because the 5-layered structure of the midface plays a central role in the human face, injecting the midface area may also indirectly improve other aesthetic concerns such as infraorbital hollowing and nasolabial folds. Nonetheless, midface rejuvenation requires a tailored treatment approach and a thorough knowledge of anatomy to minimize procedural risks and achieve natural-looking results. This article provides an extensive anatomical description of the midface and of the usual course and depth of vascular structures circulating nearby to delineate a treatment area and minimize procedural risks. Furthermore, considering the differential mobility and mechanical constraints of each layer of the midface, a multilayer treatment algorithm is proposed for adapting the treatment strategy to patient specificities (including age, gender, skin type, and morphology). Emphasis is also placed on desirable filler properties to create deep structural support on the one hand and accompany facial movement on the other hand.
- 17 January 2022
- Published by Oxford University Press (OUP) in Aesthetic Surgery Journal
- Vol. 42 (8) , 920-934
Top Cited PapersOpen AccessInjection Guidelines for Treating Midface Volume Deficiency With Hyaluronic Acid Fillers: The ATP Approach (Anatomy, Techniques, Products)
Midface rejuvenation is among the most valuable indications of hyaluronic acid dermal fillers, because malar projection and full upper cheeks significantly contribute to a youthful appearance. Hyaluronic acid fillers have evolved over the past 2 decades to meet specific clinical needs such as strong projection capacity and adaptability to facial dynamism. As a result, they now represent the treatment of choice for midface rejuvenation throughout age ranges by offering the potential for noninvasive treatment, immediate results, and minimal downtime. Because the 5-layered structure of the midface plays a central role in the human face, injecting the midface area may also indirectly improve other aesthetic concerns such as infraorbital hollowing and nasolabial folds. Nonetheless, midface rejuvenation requires a tailored treatment approach and a thorough knowledge of anatomy to minimize procedural risks and achieve natural-looking results. This article provides an extensive anatomical description of the midface and of the usual course and depth of vascular structures circulating nearby to delineate a treatment area and minimize procedural risks. Furthermore, considering the differential mobility and mechanical constraints of each layer of the midface, a multilayer treatment algorithm is proposed for adapting the treatment strategy to patient specificities (including age, gender, skin type, and morphology). Emphasis is also placed on desirable filler properties to create deep structural support on the one hand and accompany facial movement on the other hand.
- Top Cited PapersOpen Access
- 21 January 2021
- Published by Wolters Kluwer Health in Dermatologic Surgery
- Vol. 47 (5) , e159-e167
Advanced Concepts in Rheology for the Evaluation of Hyaluronic Acid–Based Soft Tissue Fillers
BACKGROUND: Crosslinked hyaluronic acid (HA)-based soft tissue fillers possess unique viscoelastic properties intended to match specific product indications. Manufacturing has an impact on HA chain integrity and on filler properties. OBJECTIVE: This study introduces 2 new rheological parameters to evaluate the macroscopic characteristics of fillers. METHODS AND MATERIALS: A library of reference commercialized HA fillers was selected to cover the full spectrum of product indications. Gels were assessed in terms of size of released HA fragments as a readout of gel integrity, degree of modification, cohesivity, and rheological properties. RESULTS: The elastic modulus G′ often used to characterize fillers was shown not to follow macroscopic mechanical properties. To improve the mechanical characterization of fillers, Strength and Stretch scores were developed and tested. The Strength score defined the ability of a filler to sustain constant viscoelasticity over a wide range of constraints and represented the filler mechanical resilience. The Stretch score measured the propensity of a filler to deform in view to improve implant adaptation to facial animation for natural-looking results. CONCLUSION: Strength and Stretch scores sorted rheological parameters to macroscopic cohesivity assays more accurately than G′ and may thus help predict the gel behavior once implanted and submitted to facial dynamics.
- 21 January 2021
- Published by Wolters Kluwer Health in Dermatologic Surgery
- Vol. 47 (5) , e159-e167
Top Cited PapersOpen AccessAdvanced Concepts in Rheology for the Evaluation of Hyaluronic Acid–Based Soft Tissue Fillers
BACKGROUND: Crosslinked hyaluronic acid (HA)-based soft tissue fillers possess unique viscoelastic properties intended to match specific product indications. Manufacturing has an impact on HA chain integrity and on filler properties. OBJECTIVE: This study introduces 2 new rheological parameters to evaluate the macroscopic characteristics of fillers. METHODS AND MATERIALS: A library of reference commercialized HA fillers was selected to cover the full spectrum of product indications. Gels were assessed in terms of size of released HA fragments as a readout of gel integrity, degree of modification, cohesivity, and rheological properties. RESULTS: The elastic modulus G′ often used to characterize fillers was shown not to follow macroscopic mechanical properties. To improve the mechanical characterization of fillers, Strength and Stretch scores were developed and tested. The Strength score defined the ability of a filler to sustain constant viscoelasticity over a wide range of constraints and represented the filler mechanical resilience. The Stretch score measured the propensity of a filler to deform in view to improve implant adaptation to facial animation for natural-looking results. CONCLUSION: Strength and Stretch scores sorted rheological parameters to macroscopic cohesivity assays more accurately than G′ and may thus help predict the gel behavior once implanted and submitted to facial dynamics.
- Open Access
- 1 December 2020
- Published by Wolters Kluwer Health in Plastic and Reconstructive Surgery - Global Open
- Vol. 8 (12) , e3274
Objective 18-month Comparison of the Tolerability of 2 Dermal Fillers Formulated with Tri-Hyal Technology
Background: The first phase of this study showed that ART FILLER Universal filler (AFU; FILORGA Laboratories) and ART FILLER Fine lines (AFFL) were non-inferior to JUVÉDERM Ultra 3 (Allergan) and FIRST LINES PureSense (Teoxane), respectively. The clinical benefits of AFU and AFFL on nasolabial folds and crow’s feet persisted until at least Day 180. This article reports results from an open-label extension phase that assessed the tolerability and efficacy of AFU and AFFL for up to 18 months based on clinical evaluation and ultrasound high-frequency imaging. Methods: Eligible subjects were enrolled at D180 and assessed on D270, D360, and D540. The primary outcome measured was local tolerability. Secondary outcomes measured included: proportion of subjects in whom the severity of nasolabial folds and crow’s feet remained at least 1 point below the baseline measurement (Lemperle scale); general safety; Global Aesthetic Improvement Scale scores by subjects and investigators; wrinkle volumes; and skin thickness by high-frequency ultrasound. Results: Adverse events were consistent with the product information and the initial study. No serious adverse events were recorded. In exploratory analyses, wrinkle correction with AFU and AFFL is sustained for at least 18 months: 48.4% and 98.3% of subjects respectively still showed at least a 1-point decrease in the mean Lemperle score compared with the baseline. The benefits were sustained irrespective of whether subjects received additional injections. Modifications in wrinkle volume and skin thickness at D540 were statistically significant compared with the baseline. Conclusion: AFU and AFFL were well tolerated and, in exploratory analyses, showed a sustained efficacy for at least 18 months.
- 1 December 2020
- Published by Wolters Kluwer Health in Plastic and Reconstructive Surgery - Global Open
- Vol. 8 (12) , e3274
Open AccessObjective 18-month Comparison of the Tolerability of 2 Dermal Fillers Formulated with Tri-Hyal Technology
Background: The first phase of this study showed that ART FILLER Universal filler (AFU; FILORGA Laboratories) and ART FILLER Fine lines (AFFL) were non-inferior to JUVÉDERM Ultra 3 (Allergan) and FIRST LINES PureSense (Teoxane), respectively. The clinical benefits of AFU and AFFL on nasolabial folds and crow’s feet persisted until at least Day 180. This article reports results from an open-label extension phase that assessed the tolerability and efficacy of AFU and AFFL for up to 18 months based on clinical evaluation and ultrasound high-frequency imaging. Methods: Eligible subjects were enrolled at D180 and assessed on D270, D360, and D540. The primary outcome measured was local tolerability. Secondary outcomes measured included: proportion of subjects in whom the severity of nasolabial folds and crow’s feet remained at least 1 point below the baseline measurement (Lemperle scale); general safety; Global Aesthetic Improvement Scale scores by subjects and investigators; wrinkle volumes; and skin thickness by high-frequency ultrasound. Results: Adverse events were consistent with the product information and the initial study. No serious adverse events were recorded. In exploratory analyses, wrinkle correction with AFU and AFFL is sustained for at least 18 months: 48.4% and 98.3% of subjects respectively still showed at least a 1-point decrease in the mean Lemperle score compared with the baseline. The benefits were sustained irrespective of whether subjects received additional injections. Modifications in wrinkle volume and skin thickness at D540 were statistically significant compared with the baseline. Conclusion: AFU and AFFL were well tolerated and, in exploratory analyses, showed a sustained efficacy for at least 18 months.