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

Kopera, Daisy; Palatin, Michael; Bartsch, Rolf; Bartsch, Katrin; O’Rourke, Maria; Höller, Sonja; Baumgartner, Renate; Prinz, Martin

doi:10.1155/2015/195328

Cited by 22 publications

(25 citation statements)

References 20 publications

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“…The observed decrease in improvement between Week 24 and Week 36 is in line with published data on the longevity of HA fillers of about 4 to 12 months 10 . Comparing the maintenance of the improvement of NLFs with results of a previous investigation using the HA filler Princess VOLUME, the equivalent device but without lidocaine hydrochloride in the formulation, 8 results confirm the reports demonstrating that the addition of lidocaine has no effect on the longevity of the dermal filler 5 …”

Section: Discussionsupporting

confidence: 89%

“…The subjects' rating of satisfaction showed high and consistent satisfaction with the result of the treatment. Subjects rated their appearance independent of the investigator's GAIS assessment as “very satisfied” in 85.2% of subjects at Week 4, 78.7% at Week 24, and 79.0% at Week 36; these results conform to the GAIS scores, and to results of the investigation of Princess VOLUME (an equivalent product but without lidocaine in the formulation) 8 …”

Section: Discussionsupporting

confidence: 53%

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A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds

Kopera

Ivezić-Schoenfeld

Chang-Rodriguez

et al. 2020

Dermatologic Therapy

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The aim of this study was to investigate the safety and performance of Princess VOLUME Lidocaine in nasolabial fold correction. In this prospective, open label, multicenter, postmarket study subjects received injections of Princess VOLUME Lidocaine into both NLF at Baseline (Day 0) and if considered necessary by the investigator, at Week 2 (touch-up treatment). This study was conducted in Austria at the Department of Dermatology and Venereology, Medical University of Graz, at the medical aesthetic center MÄZ WIEN, and at the medical aesthetic center Ordination Dr. Bartsch, Vienna. The 62 mainly female (95.2%) subjects had a median age of 52 years with two fully visible, approximately symmetrical NLFs, each scoring grade 2 or 3 on the nasolabial fold severity rating scale (NLF-SRS) developed by Croma-Pharma. The nasolabial fold severity was assessed by NLF-SRS and Global Aesthetic Improvement Scale (GAIS) 4, 24, and 36 weeks later. Adverse events (AEs) were recorded throughout the investigation. With 95.1% of subjects showing an improvement of at least 1 grade of the NLF-SRS at 24 weeks after the treatment, the primary endpoint was achieved, and clinical performance was demonstrated. Princess VOLUME Lidocaine was well tolerated, with only mild AEs, mainly injection site reactions, reported. Subject satisfaction (≥93.5%) and GAIS scores (≥93.5% improvement) were high. Princess VOLUME Lidocaine was effective in reducing NLFs as shown by an improvement in the severity of NLFs by at least one grade in 95.1% of subjects at Weeks 4 and 24.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 53%

A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds

Kopera

Ivezić-Schoenfeld

Chang-Rodriguez

et al. 2020

Dermatologic Therapy

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“…were obtained in a study in which nasolabial folds were treated with PV and observed over 270 days. 5 The literature data from long-term studies on similar devices are in line with these observations. 6,8 Prolongation of the effect can also be facilitated by an additional touch-up at later time points (ie, at 12 and 24 months).…”

Section: Discussionsupporting

confidence: 73%

“…Even after the longer follow‐up time of nine months, the positive treatment effect was still evident in well above 60% of patients attending this final visit. Comparable results were obtained in a study in which nasolabial folds were treated with PV and observed over 270 days 5 . The literature data from long‐term studies on similar devices are in line with these observations 6,8 .…”

Section: Discussionsupporting

confidence: 64%

Long‐term effectiveness of a hyaluronic acid soft tissue filler in patients with facial lipoatrophy, morphological asymmetry, or debilitating scars

Grablowitz¹,

Ivezić-Schoenfeld

Federspiel

et al. 2020

J of Cosmetic Dermatology

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Background Soft tissue fillers are typically used for rejuvenating an aging face; they are also employed in the treatment of certain pathologic conditions, including facial lipoatrophy, morphological asymmetry, and debilitating scars. Aims The aim of this clinical study was to evaluate the effectiveness and safety of Princess® Volume (PV) in patients with facial lipoatrophy (FLA), morphological asymmetry (MA), or debilitating scars (DS). Patients/Methods This prospective, noncomparative, multicenter clinical study consisted of five visits spread across 36 weeks. Up to 60 adult patients suffering from moderate facial lipoatrophy, facial morphological asymmetry, or debilitating scars on the face were to be included. All patients were treated with an HA filler (PV). Results At Week 4, the treatment success rate in the SP was 98% (95% CI [90.4%, 100%]), as assessed by both the investigators and the patients. According to the independent reviewer, the success rate was 93% (95% CI [82.7%, 98.0%]). At Week 24, the effect was maintained in most patients, with success rates of 80% as evaluated by the investigator and 79% by the patient (95% CI [67.6%, 89.8%] and [65.6%, 88.4%], respectively). At Week 36, success rates dropped to 61% as assessed by the investigator and 59% by the patient (95% CI [46.8%, 73.5%] and [45.0%, 71.9%], respectively). Conclusions The clinical study has proven that Princess® Volume is a safe and effective therapeutic solution for the correction of soft tissue defects in FLA and facial MA, but limited success rate to DS.

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“…Taken together, these results were consistent with results of previous investigations using the HA Fillers, Princess ® FILLER, the equivalent device but without lidocaine hydrochloride, and Princess ® VOLUME, the equivalent device but with a higher dynamic viscosity. In these investigations, the use of the Princess ® fillers was highly successful in the treatment of facial lipoatrophy, morphological asymmetry and debilitating scars (Princess ® FILLER) and in the treatment of NLFs (Princess ® VOLUME) over a 6-month period, as judged by investigators, subjects, and independent reviewers 15–17. All ADEs that were reported in this investigation (ie, injection site hematoma, pain, and swelling) were mild or moderate, transient, and are commonly reported following treatment with dermal fillers 18…”

Section: Discussionmentioning

confidence: 99%

<p>Safety And Efficacy Of Princess<sup>®</sup> FILLER Lidocaine In The Correction Of Nasolabial Folds</p>

Grablowitz

Sulovsky²,

Höller

et al. 2019

CCID

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PurposeNasolabial folds (NLFs) are one of the most noticeable signs of facial aging. NLFs negatively affect self-confidence and social acceptance often leading to a person’s desire to improve their appearance using dermal fillers. The hyaluronic acid injectable gel implant Princess® FILLER Lidocaine (PFL) is a minimally invasive easy to administer the product. In this investigation, we assessed the safety and efficacy of PFL to correct moderate to severe NLFs over a 36-week period.MethodsAdult women and men with moderate to severe NLFs received one injection of PFL to both NLFs. After 2 weeks, a touch-up treatment could be performed, if deemed necessary by the investigator. The change in NLF severity was assessed using the Nasolabial Fold Severity Rating Scale (NFL-SRS) developed by Croma-Pharma and the Global Aesthetic Improvement Scale (GAIS).ResultsOut of 60 analyzed subjects, 59 (98.3%) had improved their NLF severity by at least 1 grade on the NFL-SRS at week 4, 58 subjects (96.7%) at weeks 24 and 36. All subjects showed aesthetic improvement (GAIS), at weeks 4 and 24. The investigator judged the aesthetics as very much improved (score of 1) in 45 (75.0%) at week 4, 48 (80.0%) at week 24, and in 39 of 60 subjects, respectively (65.0%) at week 36. Thirty-six weeks post-initial treatment, 56 of 60 subjects (93.3%) were very satisfied or satisfied with the treatment. Adverse device effects (ADEs) were mild or moderate and resolved at latest 25 days post-onset. The most commonly reported ADEs were injection site hematoma and injection site pain.ConclusionPFL was safe and effective in reducing the severity of NLFs. Most subjects were (very) satisfied with the treatment outcome throughout a 36 weeks investigation period.

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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

Cited by 22 publications

References 20 publications

A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds

A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds

Long‐term effectiveness of a hyaluronic acid soft tissue filler in patients with facial lipoatrophy, morphological asymmetry, or debilitating scars

<p>Safety And Efficacy Of Princess<sup>®</sup> FILLER Lidocaine In The Correction Of Nasolabial Folds</p>

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