Dataset Information

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.

ABSTRACT:

Background

Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers.

Aims

To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines.

Materials and methods

This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS).

Results

In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up.

Conclusions

The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.

SUBMITTER: Ehlinger-David A

PROVIDER: S-EPMC10087550 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.

Ehlinger-David Agnès A Gorj Mihai M Braccini Frédéric F Loreto Federico F Grand-Vincent Anne A Garcia Philippe P Taieb Maryna M Benadiba Laurent L Catoni Isabelle I Mathey Elena Rumyantseva ER Deutsch Jean-Jacques JJ Bahadoran Philippe P Vincent Thibaud T David Michel M Cartier Hugues H Nadra Karim K Moellhoff Nicholas N Fanian Ferial F

Journal of cosmetic dermatology 20220731 2

<h4>Background</h4>Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers.<h4>Aims</h4>To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines.<h4>Materials and methods</h4>This prospective, multi-center trial evaluated injec ...[more]

PMID: 35718985

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Project description:Introduction: Public health (PH) interventions are crucial for ensuring sustainable healthcare services. Nevertheless, they represent a neglected area in the field of health technology assessment (HTA) due to various methodological issues and their complex design that goes beyond clinical setting. The present study provides an environmental scan of HTA initiatives related to the assessment of PH technologies on a global level. Methods: We conducted a cross-sectional survey among 85 HTA-related European and international societies, health bodies, and networks from September 2018 to January 2019. The questionnaire contained four sections and 18 questions regarding activities related to the evaluation of PH technologies, information on existing PH technologies, and methodologies of assessment as well as barriers and facilitators to reaching a decision and implementing a PH technology. Results: Among 52 survey responses, the majority of the respondents came from European countries (35%), followed by North American (27%), and South American (19%) countries. The main type of organizations covered by our survey included HTA agencies, public administrations, and research institutes. Seventy-one % of the institutions reported engagement in any aspect of HTA in the area of PH (N = 37). Among those, 81% evaluated less than 5 PH technologies from 2013 to 2018. The most common barriers for reaching a decision on PH technologies were lack of data, conflicting stakeholder priorities, and methodological issues. A total of 76 PH interventions were reported, and most cited initiatives were related to chronic disease screening, prevention of infectious diseases, and maternal, prenatal, and neonatal screening. Conclusion: Our survey reported a rather limited involvement of HTA in the evaluation of PH technologies. In particular, an evaluation of behavioral and lifestyle interventions remains extremely rare. The implementation of collaborative HTA approaches in the setting of PH practice and policy needs to be prioritized and further strengthened. Moreover, ensuring reliable data structures and consolidation of HTA methods for the evaluation of PH technologies will be crucial for tackling the enormous burden of non-communicable diseases in societies.

Dataset Information

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.

Background

Aims

Materials and methods

Results

Conclusions

Publications

A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.

Similar Datasets

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