What are the most important results of this study?
In my opinion there are predominantly three points of interest: Most importantly we know that this monophasic filler is a safe product. As the correction of wrinkles by injection of HA-based fillers is an optional medical procedure and not a live-saving treatment safety is a really important issue. In treatments the like first and foremoste we have to follow the motto: no harm.
A second really important result is that this treatment has a proven efficacy. In many other products we do not have any clinical studies. Here we know we have a reliable product.
Last but not least a comparison with a previously undertaken study[1] onh two competing dermal filler showed that the cohesive monophasic HA-bsaed filler is superior to the biphasic product and to collagen preparations.
Do you have an explanation for the long lasting treatment effect ?
It is certainly not the tale about the isovolumetric degradation. At the moment we do have only poor knowledge about the biodegradation of dermal fillers in-vivo. Most of our data are results from in-vitro-studies. Therefore I can only give you my personal explaination which is in part a hypothesis and not established knowledge. Injecting any kind of filler material you have to take into account that part of it, especially of products containing particles, solid or gel-like, is migrating. Strictly speaking this is a loss of material at the site of implantation and not biodegradation in the sense of enzymatic breakdown or lysis. As a result of migration or dislocation resp. the total amount of filler substance at the injection site is reduced during the entire observation time.
The remainder undergoes biodegradation, if possible. How this is accomplished on a molecular basis is not well understood in most biodegradable filler materials. My personal opinion in the case of HA and its derivatives is, that the material is degraded by macrophages and cells of the immune system or RHS wether inside the cells or at the cell surface.
My explanation
for the longevity of the cohesive monophasic product is, that the material is
anchored in the tissue. As even finest fissures are filled with the cohesive
material it is indented in the the tissue. Migration is less probable and we
do exspect more of the injected material keeping its position instead of
filling distant organs as a consequence of migration.
In the most used
particulated biphasic fillers the medium size of the particle is 700 microns.
This is the mean value but, a Gaussian distribution provided, there are lots of
much smaller particles who are phagocytized when smaller than 20 microns or
shifted to the lymph vessels and lymph nodes by the mimic motions in the face.
Once in the lymph vessels they are true rolling stones. May be they fill the
lung but not the face and fortunately not on a long term.Additional we have
gravitation forces acting on the particles which bias the migration down and
backwards. Therefore I think that enhancement of duration of the therapeutic
effect of the monophasic cohesive gel is the real benefit of the CPM-technology
– an appropriate injection technique provided. On the base of case reports and
histological findings this is my personal explaination for the superior results
of the CPM-material.
It certainly is.
This comparison is valid, because the design of the present study is very
similar to the study by Narins and coworkers. There was not only the same
primary endpoint but also the patients and the nasolabial folds at baseline
were similar. The only meaningful difference between these studies was the
fact, that in the preceeding study two touch-up treatments were allowed.
If you take a
close look at the results of both studies, you notice that the monophasic
filler is superior to the other. With a single treatment we achieved a better
effect compared to the competing products, where more than a third of patients
got touch-up-treatments
How was the tolerability in these studies?
You have to
discriminate between side effects due to the product itsself and side effects
due to the implantation procedure, e.g. bleeding, swelling or erythema. But
even if you take this into account, the monophasic filler was better tolerated.
There were more side-effects immediately after implantation in the preceeding
study on a statistical base. Most patients in the study assessed the
tolerability as good or very good.
Case Report:
Correction of Nasolabial folds with a monophasic filler
A 42 year old
woman presented to the clinic with the wish for the correction of her
nasolabial folds. The otherwise healthy patient had a history of Nickel
allergy.
Before treatment
the investigator rated her nasolabial-folds to be SRS-grade 4 (Fig). A topical
preparation of a local anaesthetic (EmlaTM)) was applied to the
injection site before implantation to minimize pain during the procedure. The
investigator injected the material via Stratum Technique.
Immediately after
the procedure investigator and patients assessed that the folds had “very much
improved”. Fig. 2 shows a marked improvement of the nasolabial folds The
investigator rated the SRS-Score 2 after treatment.
The patient came
to a control visit after 15 days. All further presentations on day 29, 82, 166
and 251 showed that the treatment effect was still evident, even 166 (Fig.3 )
and 251 (Fig. 4) days after the initial treatment. At each visit the SRS-value
was rated 2 by the investigator.
On every visit
investigator and patient had the opinion the folds had much improved
The treatment was
also judged by a blinded reviewer according to photo-documentations. In his
opinion, the SRS-values at baseline were even 5. On the other visits he rated
them to be 2, which comes to an improvement in the SRS-scale of 3 points.
Noticeable was
the long filling state of the nasolabial fold. The investigator judged the
filling state to be 100% even at day 166 after implantation and 92% at the end
of the follow-up treatment period.
Tolerability was
fairly good. There were only mild side effects related to the injection like
erythema, swelling and haematoma which resolved within a week.
The patient seeks
no further treatment at the moment, because she is very content with the
present situation.
This case report
shows that in selected patients the treatment effect of a monophasic filler on
the basis of hyaluronic acid can last up to nine month.
Figures:
Fig. 6: Portrait Dr. Reinmüller
Fig. 6: Portrait Dr. Reinmüller
Fig. 7 :
Patient before treatment : Although the volunteer is only 42 years of age,
there are pronounced and deep nasolabialfolds.
Fig. 7: Patient
immediately after treatment. Folds are fare less evident.
Fig. 8. Patient
on day 166: Filling state was still rated 100% after this time.
Fig. 9 Patient on
day 251: The treatment effect is still evident. The patient sees no need for a
further treatment at the moment.
[1] Rhoda S. Narins, et al. A randomized
doubleblind multicenter comparison of the efficacy and tolerability of Restylane
versus Zyplast for the correction of the nasolabial folds. Dermatol Surg
2003 ; 29 :588-595
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