Voluma: A Systematic Review of Clinical Experience
September 2015 | Volume 14 | Issue 9 | Original Article | 934 | Copyright © September 2015
Derek Ho BSa and Jared Jagdeo MD MSa,b,c
aDermatology Service, Sacramento VA Medical Center, Mather, CA
bDepartment of Dermatology, University of California Davis, Sacramento, CA
cDepartment of Dermatology, State University of New York Downstate Medical Center, Brooklyn, NY
BACKGROUND: Dermal fillers are important for facial aesthetic enhancement as patients are favoring non-surgical procedures with minimal recovery time. Voluma is a volumizing hyaluronic acid filler, 20 mg/ml HA dermal filler, which was FDA-approved in 2013 as the first dermal filler for treatment of age-related volume loss in the midface.
OBJECTIVE: We sought to systematically review clinical studies and expert opinions of this 20 mg/ml HA dermal filler and to provide evidence-based recommendations and expert opinions.
METHODS AND MATERIALS: A search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts was performed on August 18th 2014.
RESULTS: Thirteen articles met inclusion and were included in our review: clinical trials with this 20 mg/ml HA dermal filler (10) and expert opinions and questionnaire survey studies of experts (3). This 20 mg/ml HA dermal filler has shown consistent, favorable results for treatment of age-related facial volume loss, aesthetic enhancement, and HIV facial lipoatrophy.
CONCLUSION: HA fillers are safe and effective with minimal recovery time and complications. Future studies with longer follow-up period and use of this 20 mg/ml HA dermal filler on areas other than midface may provide additional efficacy and safety outcomes. J Drugs Dermatol
Dermal fillers are increasing in popularity as new filling products are introduced to the market. Fillers allow for non-surgical reduction of facial wrinkles and restoration of facial volume. The FDA classifies these dermal fillers as “devices.” The main ingredient of fillers currently available on the market include hyaluronic acid (HA), poly-L-lactic acid (PLLA), poly[methyl methacrylate] (PMMA), and calcium hydroxylapatite (CaHA). Through research, physicians and scientists have a better understanding of the pathogenesis of skin aging, and treatments for age-related skin changes have moved from a two-dimensional approach with rhytid correction and facial musculature relaxation to a three-dimensional approach with facial volumization.1-3 In 2013, the American Society for Dermatologic Surgery (ASDS) reported 995,000 soft-tissue filler procedures in the United States, an increase of 8.6% from 2012.4
Voluma is a volumizing hyaluronic acid filler, 20 mg/ml HA dermal filler (Juvéderm Voluma®, Allergan Inc., Irvine, CA), which was FDA-approved in 2013 as the first filler approved in the U.S. to improve age-related volume loss in the midface. We sought to systematically review clinical studies and expert opinions of this 20 mg/ml HA dermal filler and to provide evidence-based recommendations and expert opinions.
Literature Search Strategy
Our goal was to analyze all clinical trials conducted with this 20 mg/ml HA filler. A search of the computerized bibliographic databases Medline, Embase, Embal, Biosis, SciSearch, Pascal, HCAPlus, IPA, and Dissertation Abstracts was performed on August 18th 2014. The key term used was “Voluma.” The bibliographies of all relevant articles were checked for additional articles that could not be identified in our search.
Inclusion and Exclusion Criteria
The relevant articles that met the following criteria were selected for inclusion: original clinical research studies and expert's opinion publications that investigated or discussed the use of this 20 mg/ml HA filler. Exclusion criteria included: posters/abstracts, non-patient based studies, English literature review articles, and non-English articles.
Study Selection and Data Extraction
Titles and abstracts from the electronic search were screened, and full-text articles that met the selection criteria were obtained. Information on study design, sample size, treatment regimen, follow-up periods, study outcomes, and adverse events were extracted. Two reviewers (D.H. and J.J.) independently extracted data from eligible studies and any differences were resolved through consensus.
There were a total of 50 articles that populated in our search. Articles that were not identified from the original search but from manual identification from bibliographies were included (1). Excluded articles include: posters/abstracts (3), non-patient