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Prospective, Split-Face, Randomized, Long-Term Blinded Objective Comparison of the Performance and Tolerability of Two New Hyaluronic Acid Fillers
- Source :
- Dermatologic Surgery. 43:1448-1457
- Publication Year :
- 2017
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2017.
-
Abstract
- There are requirements for long-term, objective comparisons of hyaluronic acid (HA) dermal fillers.To compare efficacy and tolerability of ART FILLER Universal (AFU) and ART FILLER Fine lines (AFFL) with the existing HA fillers for the treatment of nasolabial folds and crow's feet.Prospective, randomized, rater- and patient-blind, split-face comparison of AFU with JUVEDERM Ultra 3 (JUV) and AFFL with FIRST LINES PureSense (FLPS). The severity of nasolabial folds and crow's feet was assessed by independent blinded evaluators using the Lemperle scale at baseline, day (D) 30/D45, D90, and D180. Tolerability, Global Aesthetic Improvement Scale (GAIS), wrinkle volumes, and skin thickness and density were also measured at D30/D45, D90, and D180.At D30 and D180 respectively, 61 and 57 patients were assessed. Scores for nasolabial folds and crow's feet showed statistically significant improvements at D30, D90, and D180. AFU and AFFL were noninferior to JUV and FLPS, respectively. Most patients showed GAIS improvements, maintained until at least D180 and significant increases of collagen synthesis in crow's feet and nasolabial folds. Treatments were well tolerated.AFU and AFFL are noninferior to comparators. The methodology used represents a novel approach to augment existing clinical assessment of HA fillers.
- Subjects :
- Adult
Male
Filler (packaging)
Nasolabial Fold
Injections, Subcutaneous
Dentistry
Cosmetic Techniques
Dermatology
Eye
law.invention
030207 dermatology & venereal diseases
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
law
Dermal Fillers
Hyaluronic acid
Humans
Medicine
Single-Blind Method
Prospective Studies
Hyaluronic Acid
Aged
Skin
business.industry
General Medicine
Middle Aged
Nasolabial fold
Skin Aging
medicine.anatomical_structure
chemistry
Tolerability
030220 oncology & carcinogenesis
Female
Surgery
business
Subjects
Details
- ISSN :
- 15244725 and 10760512
- Volume :
- 43
- Database :
- OpenAIRE
- Journal :
- Dermatologic Surgery
- Accession number :
- edsair.doi.dedup.....5169df0c3bf71c7bdf38d827e99a258a
- Full Text :
- https://doi.org/10.1097/dss.0000000000001193