Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.
BACKGROUND
The porcine collagen-derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.).


METHODS
Subjects with moderate to deep nasolabial wrinkles (n=149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR.


RESULTS
Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced.


CONCLUSIONS
The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non-touch-up subjects.
Dermatology Surgery and Laser Center of NY, White Plains, New York 10604, USA. rsnmd@worldnet.att.net
Rhoda S
RS
Narins
Fredric S
FS
Brandt
Z Paul
ZP
Lorenc
Corey S
CS
Maas
Gary D
GD
Monheit
Stacy R
SR
Smith
D000328:Adult; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D003094:Collagen / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D003357:Cosmetic Techniques / Q000009:adverse effects; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D012266:Ribose / Q000737:chemistry; D016037:Single-Blind Method; D015595:Skin Aging; D013997:Time Factors; D016896:Treatment Outcome
D001672:Biocompatible Materials; D012266:Ribose; D006820:Hyaluronic Acid; D003094:Collagen; C445361:Restylane