Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion
April 2024 | Volume 23 | Issue 4 | 255 | Copyright © April 2024
Published online March 20, 2024
Andreas Nikolis MD PhDa,b, Shannon Humphrey MDc, Jason K. Rivers MDd,e, Vince Bertucci MDf, Nowell Solish MDg,h, William McGillivray MDi, Kristy Bailey MDj, Nathan Rosen MDk, Andrei Metelitsa MDl,m, Annika Rugheimer MScn, Felipe Weinberg MDo, Inna Prygova MDn, Torun Bromee PhDn
aVictoria Park Medispas, Montreal, Quebec, Canada
bDivision of plastic surgery, McGill University, Montreal, Quebec, Canada
cThe Centre for Clinical Trials Inc., Vancouver, British Columbia, Canada
dPacific Derm, Vancouver, British Columbia, Canada
eDepartment of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada
fBertucci MedSpa, Woodbridge, Ontario, Canada
gSweat Clinics of Canada, Toronto, Ontario, Canada
hUniversity of Toronto, Toronto, Ontario, Canada
iDr. William McGillivray Inc., Vancouver, British Columbia, Canada
jFCP Dermatology, Toronto, Ontario, Canada
kDermetics, Burlington, Ontario, Canada
lBeacon Dermatology, Calgary, Alberta, Canada
mDivision of Dermatology, University of Calgary, Calgary, Alberta, Canada
nGalderma, Uppsala, Sweden
oGalderma, Dallas, TX
Abstract
Background: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.
Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.
Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported.
Conclusions: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months.
J Drugs Dermatol. 2024;23(4):255-261. doi:10.36849/JDD.8145
INTRODUCTION
The shape, projection, and profile of the chin are important components of facial attractiveness in both men and women. Chin retrusion may be perceived as less attractive and associated with a desire for chin correction or elongation.
1 Procedures for enhancing chin appearance include surgical procedures, such as permanent alloplast implants (eg, silicone), bony osteotomy, autologous fat transplant, and non-surgical alternatives, such as different types of dermal fillers (eg, silicone, calcium hydroxylapatite, and hyaluronic acid (HA) fillers).
2-4 For patients seeking a minimally invasive and reversible option, HA fillers have shown high patient satisfaction and low risk of severe complications.
5 In addition to a favorable safety profile, filler treatments offer fast recovery
3,6 and the flexibility to tailor treatments to meet individual needs, including changes in appearance due to aging. Even though the global market offers a wide variety of HA fillers with different physicochemical and rheological characteristics, there remains a need for a strong/firm HA injectable that mimics the natural shape of the bony chin.
NASHA technology utilizes minimal modification and mild processing that preserves the long natural HA chains, resulting in strong/firm products with high G' (an indicator of strength/firmness). The NASHA products are
