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Observational Study
. 2014 Jun;13(2):125-34.
doi: 10.1111/jocd.12085.

A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips

Wolfgang G Philipp-Dormston  1 , Said Hilton, Myooran Nathan
Affiliations
Free PMC article
Observational Study

A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips

Wolfgang G Philipp-Dormston et al. J Cosmet Dermatol. 2014 Jun.
Free PMC article

Abstract

Hyaluronic acid (HA)-based injectable fillers three-dimensionally restore the natural contours of the lips and perioral area, thereby reducing some signs of aging lips. To evaluate the short-term aesthetic impact of treatment with the HA dermal filler Juvéderm(®) VOLBELLA(®) with Lidocaine, formulated utilizing VYCROSS(™) technology, for enhancement or correction of asymmetry of the lips, evaluated using a patient-centric approach. Sixty-two subjects were enrolled in this study, conducted at two sites in Germany. Primary endpoints were satisfaction with improvement, look and feel of the lips, assessed by subject and physician at first visit and 4 weeks post-treatment. Immediately after injection at first visit, 83.6% of subjects were Extremely Satisfied, Very Satisfied or Satisfied with improvement in the lips, which increased to 94.1% and 93.0% of subjects with/without top-up treatment at follow-up, respectively. After injection at first visit, 61.7% of subjects rated the look and feel of their lips as Extremely Natural or Very Natural, which increased to 75.0% and 93.0% of subjects with/without top-up treatment, respectively. The HA dermal filler was associated with minimal discomfort, bruising or swelling of the lips; almost two-thirds of subjects (62%) returned to social engagements on the same day. The high degree of subject satisfaction with aesthetic improvement in the lips, as well as the natural look and feel, indicates that this HA dermal filler represents an effective treatment option for patients requiring lip enhancement.

Keywords: Juvéderm; VOLBELLA; VYCROSS; dermal filler; hyaluronic acid; lips.

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Figures

Figure 1
Figure 1
Treatment protocol and evaluations. Primary endpoints are dark blue; secondary endpoints are light blue. HA: Hyaluronic acid; IQ1V: Injector Questionnaire – First Visit; IQEOS: Injector Questionnaire – End of Study; IQFV: Injector Questionnaire – Follow-up Visit; SQ1V: Subject Questionnaire – First Visit; SQFV: Subject Questionnaire – Follow-up Visit.
Figure 2
Figure 2
Lips of patient 1 (a) before treatment and (b) post-treatment with the HA dermal filler at the follow-up visit. Lips of patient 2 (c) before treatment and (d) post-treatment with the HA dermal filler at the follow-up visit.
Figure 3
Figure 3
Subject satisfaction with improvement in lips following treatment with the HA dermal filler at first visit.
Figure 4
Figure 4
Subject rating of natural look and feel of lips following treatment with the HA dermal filler at first visit.
Figure 5
Figure 5
Physician rating of swelling in subjects' lips just after treatment with the HA dermal filler at first visit.
Figure 6
Figure 6
Subjects' return to social engagement after treatment with the HA dermal filler at first visit.
Figure 7
Figure 7
Physician rating of ease of injection* and malleability** when using the HA dermal filler. *Ease of injection rated on a scale from 0 (Very Easy) to 10 (Extremely Difficult). **Malleability rated on a scale from 0 (Extremely Malleable/Not Hard to Mold) to 10 (Not Malleable/Hard to Mold).
Figure 8
Figure 8
Physician rating of need for massage with the HA dermal filler.
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