Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.

4 Large controlled trial

What this means for you: this demonstrably works.

Type of study: controlled trial
Studied in: people
Participants: 149
Published: 2008 in Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
Cited: 14 times by other research
Who paid: Not declared. PubMed carries no conflict-of-interest statement for most articles; that is not the same as independent.
Source: PubMed 18547179 · doi 10.1111/j.1524-4725.2008.34240.x

The plain-language write-up of this study is still being written. Below is the abstract exactly as the researchers published it.

Abstract by the researchers — original text

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 & MATERIALS: 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. CONCLUSION: 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.