Princess Volume Plus Lidocaine May be Effective, Safe in Midface Volume Deficit Surgery

Patients who received Princess Volume Plus Lidocaine injections to correct midface volume deficit (MVD) found the treatment to be efficacious and safe, and those with moderate or severe MVD had sustained long-term aesthetic improvement, according to study findings published in the Aesthetic Surgery Journal.

Authors of an open-label prospective postmarketing study sought to assess safety, efficacy, patient satisfaction, and long-term performance associated with the use of Princess Volume Plus Lidocaine (PVPL) (Croma-Pharma GmbH, Leobendorf, Austria), a hyaluronic acid-based dermal filler, in patients with MVD.

The PRIMAvera study (ClinicalTrials.gov Identifier: NCT03532126) was a multicenter, prospective, interventional, open-label, noncomparative postapproval study conducted from March 2018 to June 2020 at 4 European clinical sites. It included 91 individuals with moderate or severe MVD, defined as a score of 2 or 3 out of 5 on the Midface Volume Deficit Severity Scale (MVDSS), who were assessed by investigators and the independent contracted photography reviewer.

The majority of study participants had grade 3 MVDSS (severe) at baseline. Among the participants, the median age was 57 years (range 30-82), 99% of participants were White, and 82% were women. One of the 4 centers included a subcohort of 10 patients with HIV drug-related facial lipoatrophy (FLA).

All were injected with PVPL on day 0 (baseline). Planned follow-up assessments occurred at weeks 2, 4, 12, 24, 36, and 52, and continued for a period of 3 years. A touch-up treatment was possible at week 2 if deemed appropriate (ie, if the investigator decided that the initial treatment had not achieved the optimal result). A total of 70 participants received touch-up treatment. The mean total volume of PVPL injected at day 0 was 4.000 mL for all participants. The mean PVPL volume injected at week 2 was 1.877 mL in the main group of participants and 3.580 mL and 3.444 mL, respectively, in the HIV subgroup with FLA. Mean and median follow-up duration in the main group and the HIV subgroup was 332.7 days and 330.0 days, respectively.

At week 4, based on at least 3 facial photographs (frontal view, left oblique, right oblique), investigators noted that 100% of participants had improved by at least 1 grade on the MVDSS compared with baseline (P <.05). At week 4, improvement by 2 grades on the MVDSS compared with baseline was observed in 65.4% of participants in the main study group and in 100% of participants in the HIV subgroup (P <.05; with 60% of those in the HIV group showing an improvement by 3 grades). At week 12, all participants maintained the MVDSS improvement of at least 1 grade, but the treatment effect gradually declined over the remaining follow-up visits.

Improvements of at least 2 grades on the MVDSS were observed in approximately half (48.3%) of the entire study cohort up to week 52, with greater improvements seen among participants in the HIV subgroup.

At week 52, 77% of participants had visible improvements as assessed by the investigators and contracted reviewer. The treatment effect continued for 386 days (median) based on the Global Aesthetic Improvement Scale and on post hoc survival analysis performed by a contracted investigator.

Regardless of the volume of PVPL injected at baseline, the effects of treatment lasted longer in severe cases. All participants but 2 had dropped out of the study after 18 months. Investigators noted that the probability of treatment effects lasting after 400 days was not above 50% and the probability of treatment effects lasting after 550 days was approximately 25%.

Self-reported questionnaires were used to assess participant satisfaction. At week 4, approximately 25% of participants reported being satisfied and 71% reported being very satisfied. Satisfaction percentages decreased at all follow-up assessments. At week 52, approximately 78% of study participants remained pleased with their treatment results: 28% of participants reported being satisfied and 50% reported being very satisfied. At month 15, 3 of 4 remaining participants reported being satisfied or very satisfied. At month 18, the 3 remaining participants were satisfied or very satisfied with their treatment.

In the main study group, 36% of participants reported adverse effects (AEs), and 5% reported serious adverse effects (SAEs). SAEs were considered unrelated to treatment. In the subgroup of participants with HIV, 100% reported AEs and 10% reported SAEs. AEs among the study participants included infections (35 events), nasopharyngitis (23 events), tooth extraction (2 events), and other AEs. Injection-site hematoma was reported by approximately 37% of participants, injection site pain by 23%, and injection site swelling by 10%.

Study limitations include high participation drop-out at week 52, undocumented PVPL volume injected in each subregion of the midface, no randomized control group, and unreported confounders (such as specific patient and procedural characteristics, and medical history).

“Princess Volume Plus Lidocaine was perceived as safe and effective by subjects/investigators, with a long-term aesthetic improvement in moderate and severe cases,” the authors concluded. They wrote, “In summary, hyaluronic acid-lidocaine dermal filler adverse effects are mild and temporary, which was confirmed with our PVPL study,” and added that PVPL was well tolerated, “in line with comparable study results of similar products currently marketed for this indication.”

Disclosure: This research was supported by Croma Pharma GmbH, Leobendorf, Austria. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.