Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess® FILLER

Daisy Kopera, Zrinka Ivezic-Schoenfeld, Ira G Federspiel, Doris Grablowitz, Benjamin Gehl, Martin Prinz, Daisy Kopera, Zrinka Ivezic-Schoenfeld, Ira G Federspiel, Doris Grablowitz, Benjamin Gehl, Martin Prinz

Abstract

Purpose: The aim of this study was to evaluate the effectiveness and safety of hyaluronic acid (HA) dermal filler when used in the face for medical reconstructive purposes.

Patients and methods: Adult patients with moderately severe facial lipoatrophy (FLA), morphological asymmetry (MA) of the face, or debilitating scars (DS) on the face were included in a prospective, noncomparative, multicenter, postmarket clinical follow-up study. All patients were treated with an HA filler (Princess® FILLER), which was injected intradermally on study Day 1, with optional touch-up 2 weeks later. The effectiveness of the treatment was evaluated at Weeks 4 and 24, using a six-grade scale ranging from "excellent" to "worsening". The assessments were conducted by both the investigator and the patient and, at Week 4, by the independent photography reviewer as well. Adverse events were collected at each visit.

Results: Fifty-three patients were included in the study (FLA 23, MA 17, and DS 13), and 46 patients completed a 6-month follow-up (FLA 20, MA 15, and DS 11). At Week 4 (primary endpoint), the overall treatment success rate was 100% (FLA), 100% (MA), and 94% (DS), based on assessments made by the investigator, patients, and the independent reviewer, respectively. In most patients (~95%), the effect was sustained over 6 months. Treatment-related adverse events were reported in five patients (9%) and included injection site hematoma, injection site pain, and headache.

Conclusion: Dermal filling with HA gel is a viable treatment option for the correction of various deformities of the face resulting from FLA, MA, or DS.

Keywords: Princess® FILLER; clinical study; dermal filler; effectiveness; hyaluronic acid; safety.

Figures

Figure 1
Figure 1
Success rates of treatment after administration of the hyaluronic acid dermal filler Princess® FILLER, overall and by indication (safety population, observed cases’ analysis). Notes: Treatment outcome was evaluated by the INV, by the patient and, at Week 4, by the IPR. Success was defined as an excellent, good, or moderate correction of the defect. Worsening was not observed in any patient. (A) Overall Success Rate of treatment after administration. (B) Success Rate of treatment after administration in patients with facial lipoatrophy. (C) Success Rate of treatment after administration in patients with morphological asymmetry. (D) Success Rate of treatment after administration in patients with debilitating scars. Abbreviations: INV, investigator; IPR, independent photography reviewer.
Figure 2
Figure 2
Facial lipoatrophy correction with hyaluronic acid dermal filler. Notes: A 61-year-old patient suffering from grade 2 facial lipoatrophy (Ascher’s scale), before (A and D) and after the treatment at Week 4 (B and E) and Week 24 (C and F). A total of 8 mL of the filler was injected into the midface: 6 mL on Day 1 and 2 mL 2 weeks later for a touch-up on the left side.
Figure 3
Figure 3
Scar correction with hyaluronic acid dermal filler. Notes: A 49-year-old patient with atrophic scars on the chin, before (A) and after the treatment at Week 4 (B) and Week 24 (C). A total of 4.4 mL of the filler was injected into the lower face: 3.4 mL on Day 1 and 1 mL 2 weeks later for a touch-up.
Figure 4
Figure 4
Additional examples of facial lipoatrophy correction with hyaluronic acid dermal filler. Notes: Top: a 55-year-old patient suffering from grade 3 facial lipoatrophy (Ascher’s scale), before (left) and after (right) the treatment at Week 4. A total of 5 mL of the filler was injected into the upper, mid, and lower face (left and right) with no additional touch-up. Bottom: a 58-year-old patient suffering from grade 3 facial lipoatrophy (Ascher’s scale), before (left) and after (right) the treatment at Week 4. A total of 5 mL of the filler was injected into the upper, mid, and lower face (left and right) with no additional touch-up.

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