An 18-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Moderate Nasolabial Folds.
BACKGROUND
Hyaluronic acid (HA) filler injection is a popular nonsurgical aesthetic procedure.


OBJECTIVE
To compare the effectiveness and safety of 2 hyaluronic acid fillers (HAEC and HARES) for treatment of moderate nasolabial folds (NLFs).


METHODS
This was an evaluator- and subject-blinded split-face study. HAEC or HARES was randomly assigned to the left or right NLF at baseline. Retreatment was performed after 9 months; follow-up extended to 18 months after baseline (9 months after retreatment). Effectiveness assessments included the Wrinkle Severity Rating Scale (WSRS) and subject preference. Safety assessments included adverse events (AEs) and local tolerability symptoms recorded by subjects during 3 weeks after treatment.


RESULTS
HAEC was noninferior to HARES measured as mean change from baseline in WSRS score at 6 months. Mean WSRS score change from baseline was similar between products up to 18 months. A majority of subjects (>70%) were still responders at 18 months (after retreatment at 9 months). The volume required at retreatment was approximately two-thirds of that at baseline. There was no difference in subject preference between products. Both fillers were well tolerated and associated with few treatment-related AEs.


CONCLUSIONS
HAEC and HARES were effective and well tolerated for treatment of moderate NLFs.
*RZANY & HUND, Privatpraxis, Berlin, Germany; †Department of Dermatology and Allergology, HSK Wiesbaden, Lehrkrankenhaus der Universität Mainz, Wiesbaden, Germany; ‡Department of Dermatology, Cannes Hospital, Cannes, France; §Centre dermato-chirurgical et médecine de la nutrition, Bordeaux, France; ‖Dermatologische Praxis, Wuppertal, Germany; ¶CPCAD, Hôpital l'Archet 2, Nice, France; #Gemeinschaftspraxis für Dermatologie, Mahlow, Germany; **Praxis Dr. med. Boris Sommer, Frankfurt, Germany; ††Galderma, Uppsala, Sweden; ‡‡Department of Dermatology, Klinikum Darmstadt, Darmstadt, Germany.
Berthold
B
Rzany
Christiane
C
Bayerl
Isaac
I
Bodokh
Dominique
D
Boineau
Thomas
T
Dirschka
Catherine
C
Queille-Roussel
Michael
M
Sebastian
Boris
B
Sommer
Carolina
C
Edwartz
Maurizio
M
Podda
D000328:Adult; D000368:Aged; D000067548:Dermal Fillers / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D057240:Patient Preference; D019233:Retreatment; D015595:Skin Aging; D013997:Time Factors; D016896:Treatment Outcome
D000067548:Dermal Fillers; D006820:Hyaluronic Acid