| A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds. | |
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MedLine Citation:
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PMID: 18086061 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Non-animal-stabilized hyaluronic acid (NASHA) offers longer-lasting cosmetic improvement and reduced risk of hypersensitivity and requires less injection volume than bovine collagen-derived dermal fillers. Porcine collagen-derived Dermicol-P35 has low immunogenicity and has the potential to provide durability at least equivalent to that of NASHA. OBJECTIVE: The objective was to evaluate the efficacy and safety of Dermicol-P35 and NASHA for correction of nasolabial folds (NLFs). METHODS AND MATERIALS: A total of 149 subjects with moderate NLFs were randomized to receive Dermicol-P35 and NASHA on contralateral sides of the face. If needed, subjects could receive a repeat injection 2 weeks later to obtain an optimal cosmetic result (OCR). RESULTS: Significant (p<.001) improvement in the Modified Fitzpatrick Wrinkle Scale scores relative to screening was observed after treatment with Dermicol-P35 and NASHA. Relative to the OCR visit, mean scores increased (p<.001) over time, but there were no significant differences between treatments (+0.39 and +0.37 at 6 months; p=.626). Greater proportions of subjects experienced swelling, bruising, and pain at the NASHA site. Several subjects had more induration at the Dermicol-P35 site. There was no evidence of any adverse immunologic effect. CONCLUSION: The effectiveness of Dermicol-P35 is maintained for at least 6 months and is equivalent to NASHA for the correction of NLFs. |
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Authors:
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Rhoda S Narins; Fredric S Brandt; Z Paul Lorenc; Corey S Maas; Gary D Monheit; Stacy R Smith; Sandi McIntyre |
Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] Volume: 33 Suppl 2 ISSN: 1524-4725 ISO Abbreviation: Dermatol Surg Publication Date: 2007 Dec |
Date Detail:
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Created Date: 2007-12-18 Completed Date: 2008-01-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9504371 Medline TA: Dermatol Surg Country: United States |
Other Details:
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Languages: eng Pagination: S213-21; discussion S221 Citation Subset: IM |
Affiliation:
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Dermatology Surgery and Laser Center, White Plains, New York 10604, USA. rsnmd@worldnet.att.net |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Analysis of Variance Biocompatible Materials / administration & dosage* Collagen / therapeutic use* Cosmetic Techniques Face* Female Gels Humans Hyaluronic Acid / administration & dosage*, analogs & derivatives Injections Male Statistics, Nonparametric Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Biocompatible Materials; 0/Gels; 0/Restylane; 9004-61-9/Hyaluronic Acid; 9007-34-5/Collagen |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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