Derek Jones, MD
In this presentation, Dr Jones reviews the data on Belotero, a novel therapeutic approach to dermal fillers.
Belotero utilizes CPM Technology. This is the most important difference with regards to Belotero and other dermal fillers. Belotero utilizes CPM Technology, a key differentiator between Belotero and other hyaluronic acid dermal fillers. CPM Gel provides further cross-linking steps resulting in a coherent molecule with different density zones, resulting in a coherent molecule with unique density zones.
What does this mean clinically?
While particulate biphasic fillers may lift and enlarge dermal spaces leaving lumps, Belotero integrates into dermal spaces allowing for smooth transition between treated and untreated areas.
This is important clinically as it is hypothesized that using Belotero may reduce the Tyndall effect.
Belotero US Clinical Study
The Primary Phase was a 24 week initial study in comparison to Zyplast. 118 patients were enrolled and the researchers looked at the treatment of nasolabial folds (NLFs). The open-label extension phase (OLEX) was an extension of the evaluation from 24 weeks to 96 weeks that included 85 patients.
This is important as it was an FDA pivotal trial and Dr Jones encourages everyone to review the pivotal trials on Restylane and Juvederm as well to look at similarities and differences among the fillers.
The mean age on these studies was 52.4 and the subjects were predominantly female.
In order to be eligible for this study, patients had to be a two or a three on the Wrinkle Severity Rating Score (WSRS) and to be deemed a “responder” that had to have at least a one-point improvement on this scale that was persistent.
The results demonstrated that both Belotero and Zyplast performed similarly at week 2, but by week 24 the results greatly improved with the use of Belotero.
Regarding the responder analysis, well over 50% of the subjects had at least a one- point change on the WSRS by week 24 and the percentage of subjects maintaining correction from week two to week 24 was greatly superior for Belotero.
Efficacy measured in GAIS was significantly better with Belotero versus Zyplast. In looking at the Physician’s Preference Assessment, 100% of the physicians preferred Belotero to Zyplast with regards to storage and handling, 67% preferred Belotero regarding the comfort and design of the syringe, and 33% preferred Belotero regarding ease of injection “flow”. Overall, 83% of the physicians preferred Belotero to Zyplast.
Adverse events were very similar to what one would expect with a hyaluronic acid such as erythema, bruising, and swelling. The AEs observed were not statistically significant.
The results of the Primary Phase study conclude that Belotero is superior to Zyplast in the correction of the nasolabial fold when evaluated 12 weeks after treatment. More patients preferred Belotero and the treatments were safe and well tolerated.
Belotero Balance (OLEX)
This was an open-label extension trial consisting of treatment with Belotero on both sides at completion of the 24-week visit (visits at week 32, 48, 72, 96, after the last main study treatment). Patients received touch-up treatments with Belotero in both nasolabial folds at week 24 and could receive an optimal touch-up treatment at week 32 to balance an observed unevenness between the two sides. At each of the visits, adverse events and relevant medication use was noted. The subjects could also receive optimal touch-up injections at week 48 or week 72 if the WSRS on that side is two or three. Subjects who did not receive an optimal touch-up injection at weeks 48 or 72 had the option of receiving a touch-up at week 96.
After repeat treatment, the filler starts to hold and dermatologists can see that with the other fillers as well.
The mean GAIS score, as assessed by the treating physician, was between two (improved) and three (much improved) at all timepoints. The GAIS was greater on the side of the face previously injected with HA in the double-blind trial, indicating greater improvement on that side.
During the OLEX study, there was an injection-free phase of 48 weeks in 80.2% of the patients.
At all time points during the open-label extension the treating investigator assessed improvement by both the WSRS and GAIS on both NLF.
In conclusion, Belotero appears to be a safe and well-tolerated, novel dermal filler.