BEER 2020

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Downloadedfromhttp://journals.lww.com/dermatologicsurgerybyBhDMf5ePHKbH4TTImqenVAaoM33QR5KTJ7TqdanMKYGiOX/xf9t16PKXWxQEzRLsirVjY849Y90=on03/02/2020
Hyaluronic Acid Soft Tissue Filler for the Treatment of The
Hypoplastic Chin: An Observational Study
Kenneth Beer, MD, PA,* Anthony Stonehouse, PhD,† and Monica Dunn, RN, BSN*
BACKGROUND The hypoplastic chin is associated with facial unattractiveness.
OBJECTIVE To evaluate safety and efficacy of JUVÉDERM Voluma XC Injectable Gel (hyaluronic acid filler,
HAF) for treatment of hypoplastic chin.
METHODS This was a one-year, open-label, single-center study.
RESULTS Thirty subjects received HAF injections of which 24 subjects (80%) completed the study. Mean
facial angle significantly improved at all time points compared with baseline, improving by 1.83� (95% con-
fidence interval, 0.91, 2.75; preproduction of this article is prohibited.
http://links.lww.com/DSS/A216
http://links.lww.com/DSS/A217
Secondary efficacy measures included subject respon-
ses to satisfaction with lower face and jawline, satis-
faction with overall facial appearance, and appraisal
of area under chin modules of the FACE-Q question-
naire.8–10 FACE-Q questionnaire responses for satis-
faction with lower face and jawline, and satisfaction
with overall facial appearance were dichotomized
from original outcomes of “somewhat satisfied” and
“very satisfied” to “satisfied,” and “somewhat dis-
satisfied” and“very dissatisfied” to“dissatisfied.”The
FACE-Q questionnaire responses for appraisal of area
under chinwere dichotomized fromoriginal outcomes
of “not at all bothered” and “a little bothered” to “not
bothered,” and “moderately bothered” and
“extremely bothered” to “bothered.”
The investigator-rated GAIS score was also used as a
secondary efficacy measure. The 5-point GAIS was
scored based on the investigator’s assessment of the
subject’s level of improvement at follow-up visits
compared with pretreatment. The GAIS was scored
as22 (much worse appearance), 21 (worse appear-
ance), 0 (no change), 1 (improved appearance), and 2
(much improved appearance).
Safety
During the study, treatment-related adverse events
(TRAEs) were assessed by the investigator using the
following severity classification: mild (awareness of
sign or symptom, but easily tolerated); moderate
(discomfort enough to cause interference with usual
activity); and severe (incapacitating with inability to
work or dousual activity). In addition, the investigator
assessed the relationship of TRAEs to device or pro-
cedure. Specifically, the investigator determined
whether there was a reasonable possibility that the
TRAE was caused by the device, or the procedure
(regardless of any potential relationship to device).
Serious adverse events were defined as an adverse event
which (1) lead to death; (2) lead to serious deterioration
of subject health resulting in (a) life-threatening illness
or injury, or (b) permanent impairment of a body
structure or a body function, or (c) in-subject or pro-
longed hospitalization, or (d) medical or surgical
intervention to prevent life-threatening illness or injury
or permanent impairment to a body structure or a body
function; and (3) lead to fetal distress, fetal death, or a
congenital abnormality or birth defect.
Subjects were given a diary card containing a post-
injection site reaction questionnaire, which they com-
pleted and returned to the clinic 30 days after treatment.
Figure 2. Facial angle is defined as the angle between the
glabella, subnasale and pogonion integumental landmarks.
Integumental landmarks: (A) subnasale, (B) superior labial
sulcus, (C) labrale superius, (D) labrale inferius, (E) inferior
labial sulcus, (F) menton, (G) frontal point. Subnasale (A) is
the point where the maxillary lip and the nasal septum form
a definite angle. If the depression is a gentle curve, the
subnasale is interpreted as the most concave point in this
area as measured by a line angle 45� from the nasal floor.
Superior labial sulcus (B) is the deepest point on the upper
lip as determined by a line drawn from the subnasale
inclined, so that it forms a tangent with the labrale superius.
Inferior labial sulcus (E) is the most concave point as mea-
sured by a line tangent to the menton and labrale inferius.
Menton (F) is the most anterior point of the chin, as mea-
sured by a perpendicular dropped from the nasal floor. The
hypoplastic chin is defined as a facial angle of5A,C–E).
The secondary efficacy measure of subject satisfaction
with their overall facial appearancewas assessed using
HAF FOR HYPOPLAST IC CH IN
DERMATOLOG IC SURGERY4
© 2020 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
http://links.lww.com/DSS/A218
http://links.lww.com/DSS/A218
http://links.lww.com/DSS/A217
http://links.lww.com/DSS/A217
10 survey questions: “How symmetric your face
looks?,” “How balanced your face looks?,” “How
well-proportioned your face looks?,” “How your face
looks at the end of your day?,” “How fresh your face
looks?,” “How rested your face looks?,” “How your
profile (side view) looks?,” “How your face looks in
photos?,” “How your face looks when you first wake-
up?,” and “How your face looks under bright lights?”
The percentage of subjects who were satisfied (survey
responses: “somewhat satisfied” or “very satisfied”)
increased postbaseline for all questions, however,
satisfaction significantly increased at Months 1, 2, 4,
6, and 12, for all survey questions except “How
symmetric your face looks?” (Significantly increased
atMonths 4 and 6), “Howbalanced your face looks?”
(Significantly increased at Month 4), “How well-
proportioned your face looks?” (Significantly
increased at Months 1, 4, and 12), “How rested your
face looks?” (Significantly increased atMonths 1, 2, 4,
and 6), “How your face looks in photos?” (Signifi-
cantly increased atMonths 1, 2, 4, and 12), and “How
your face looks when you first wake-up?” (No sig-
nificant increase at any time point) (Figure 6A–J).
The secondary efficacy measure of how bothered
subjects were by the area under their chinwas assessed
using 5 survey questions: “How the area under your
chin looks in profile (side view)?,” “Loose skin and fat
under your chin?,” “Sagging of the skin and fat under
your chin?,” “Lack of contour (outline) under your
chin?,” and “Fullness under your chin (e.g., double
chin)?” The percentage of subjects who were not
bothered (survey responses: “not at all bothered” or
“a little bothered”) increased postbaseline for all
questions, and significantly increased for “Fullness
under your chin (e.g., double chin)?” at all time points,
“How the area under your chin looks in profile (side
view)?” and “Lack of contour (outline) under your
chin?” atMonths 1, 2, 4, and 12, and “Loose skin and
fat under your chin?” at Months 2 and 12 (Figure
7A,B,D,E). There was no significant increase of being
not bothered by “Sagging of the skin and fat under
your chin?” at any time point (Figure 7C).
The secondary efficacy measure of GAIS was assessed
by the principal investigator, and the rating of
“improved” increased from baseline at all time points,
whereas the rating of “much improved” significantly
increased from baseline at all time points (Figure 8).
Evaluation of Safety
A total of 24 subjects (80%) completed the 12-month
study, with 2 subjects (6.7%) being lost to follow-up,
and 4 subjects (13.3%) being lost for other reasons (3
Figure 4. Photographs of a subject at baseline and Month 1 show change in facial angle (mean change at 1 month was 3.19�
[95% CI, 2.57–3.82; pMost injection-related events lasted less than
7 days; however, 2 subjects experienced lumps/bumps
which lasted for longer than 30 days.
Few subjects experienced sequelae, with 4 subjects
being “a little bothered” by parts of their face not
looking smooth, and only single subjects being “a little
bothered” and “a lot bothered” by obvious or
noticeable scars by the final 12 months visit.
Conclusions
The safe and effective treatment of the hypoplastic
chin is currently an unmet need, as existing treatment
approaches (surgery, implants, and early generation
fillers) are associated with bone erosion, migration,
and infections, and overall seem to be less safe and
effective than volumizing injectable fillers such as
HAF.2–5
In this completed one-year open-label study, HAF
injection for hypoplastic chin was shown for the first
time to significantly improve facial angle at all time
points compared with baseline (1.83� [95% CI,
0.91–2.75; pA, Kraemer J, et al. Volumizing
with a 20-mg/mL smooth, highly cohesive, viscous hyaluronic acid filler
and its role in facial rejuvenation therapy. Dermatol Surg 2010;
36(Suppl 3):1886–92.
14. Bechara FG, Gambichler T, Brockmeyer NH, Sand M, et al. Hyaluronic
acid new formulation: experience in HIV-associated facial lipoatrophy.
Dermatology 2008;217:244–9.
15. Fischer TC. A European evaluation of cosmetic treatment of facial
volume loss with Juvederm Voluma in patients previously treated with
Restylane Sub-Q. J Cosmet Dermatol 2010;9:291–6.
16. Callan P, Goodman GJ, Carlisle I, Liew S, et al. Efficacy and safety of a
hyaluronic acid filler in subjects treated for correction of midface
volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol
2013;6:81–9.
Address correspondence and reprint requests to: Kenneth
R. Beer, MD, PA, 1500 North Dixie Hwy, Suite 305, West
Palm Beach, FL 33401, or e-mail:
mdunn@beerdermatology.com
BEER ET AL
00 : 0 0 :MONTH 202 0 11
© 2020 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
https://www.accessdata.fda.gov/cdrh_docs/pdf11/p110033c.pdf
http://qportfolio.org/face-q/aesthetics/
http://qportfolio.org/face-q/aesthetics/
mailto:mdunn@beerdermatology.com