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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. Commentary

Identifieur interne : 000F64 ( Main/Merge ); précédent : 000F63; suivant : 000F65

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. Commentary

Auteurs : Rhoda S. Narins [États-Unis] ; Fredric S. Brandt [États-Unis] ; Z. Paul Lorenc [États-Unis] ; Corey S. Maas [États-Unis] ; Gary D. Monheit [États-Unis] ; R. Smith [États-Unis] ; Sandi Mcintyre [États-Unis] ; Lisa Donofrio

Source :

Dermatologic surgery [ 1076-0512 ] ; 2007.

RBID : Pascal:08-0100894

Descripteurs français

Pascal (Inist)
- Chirurgie, Essai clinique, Randomisation, Etude multicentrique, Sécurité, Toxicité, Efficacité, Animal, Acide hyaluronique, Correction, Nasolabial, Plissement, Dermatologie, Antirhumatismal, Cicatrisant, Traitement.
Wicri :
- topic : Chirurgie.

English descriptors

KwdEn :
- Animal, Antirheumatic agent, Clinical trial, Corrections, Dermatology, Efficiency, Fold, Healing agent, Hyaluronic acid, Multicenter study, Nasolabial, Randomization, Safety, Surgery, Toxicity, Treatment.

Abstract

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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Pascal:08-0100894

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<author><name sortKey="Narins, Rhoda S" sort="Narins, Rhoda S" uniqKey="Narins R" first="Rhoda S." last="Narins">Rhoda S. Narins</name>
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<country>États-Unis</country>
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<author><name sortKey="Brandt, Fredric S" sort="Brandt, Fredric S" uniqKey="Brandt F" first="Fredric S." last="Brandt">Fredric S. Brandt</name>
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<author><name sortKey="Smith, R" sort="Smith, R" uniqKey="Smith R" first="R." last="Smith">R. Smith</name>
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<author><name sortKey="Mcintyre, Sandi" sort="Mcintyre, Sandi" uniqKey="Mcintyre S" first="Sandi" last="Mcintyre">Sandi Mcintyre</name>
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<author><name sortKey="Donofrio, Lisa" sort="Donofrio, Lisa" uniqKey="Donofrio L" first="Lisa" last="Donofrio">Lisa Donofrio</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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. Commentary</title>
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<author><name sortKey="Brandt, Fredric S" sort="Brandt, Fredric S" uniqKey="Brandt F" first="Fredric S." last="Brandt">Fredric S. Brandt</name>
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<author><name sortKey="Lorenc, Z Paul" sort="Lorenc, Z Paul" uniqKey="Lorenc Z" first="Z. Paul" last="Lorenc">Z. Paul Lorenc</name>
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<author><name sortKey="Maas, Corey S" sort="Maas, Corey S" uniqKey="Maas C" first="Corey S." last="Maas">Corey S. Maas</name>
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<author><name sortKey="Monheit, Gary D" sort="Monheit, Gary D" uniqKey="Monheit G" first="Gary D." last="Monheit">Gary D. Monheit</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Therapeutics Clinical Research</s1>
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<sZ>5 aut.</sZ>
</inist:fA14>
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</placeName>
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<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
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<placeName><region type="state">Alabama</region>
</placeName>
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</author>
<author><name sortKey="Mcintyre, Sandi" sort="Mcintyre, Sandi" uniqKey="Mcintyre S" first="Sandi" last="Mcintyre">Sandi Mcintyre</name>
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<sZ>7 aut.</sZ>
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<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Donofrio, Lisa" sort="Donofrio, Lisa" uniqKey="Donofrio L" first="Lisa" last="Donofrio">Lisa Donofrio</name>
</author>
</analytic>
<series><title level="j" type="main">Dermatologic surgery</title>
<title level="j" type="abbreviated">Dermatol. surg.</title>
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<seriesStmt><title level="j" type="main">Dermatologic surgery</title>
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<idno type="ISSN">1076-0512</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Animal</term>
<term>Antirheumatic agent</term>
<term>Clinical trial</term>
<term>Corrections</term>
<term>Dermatology</term>
<term>Efficiency</term>
<term>Fold</term>
<term>Healing agent</term>
<term>Hyaluronic acid</term>
<term>Multicenter study</term>
<term>Nasolabial</term>
<term>Randomization</term>
<term>Safety</term>
<term>Surgery</term>
<term>Toxicity</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Chirurgie</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Etude multicentrique</term>
<term>Sécurité</term>
<term>Toxicité</term>
<term>Efficacité</term>
<term>Animal</term>
<term>Acide hyaluronique</term>
<term>Correction</term>
<term>Nasolabial</term>
<term>Plissement</term>
<term>Dermatologie</term>
<term>Antirhumatismal</term>
<term>Cicatrisant</term>
<term>Traitement</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Chirurgie</term>
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
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<tree><noCountry><name sortKey="Donofrio, Lisa" sort="Donofrio, Lisa" uniqKey="Donofrio L" first="Lisa" last="Donofrio">Lisa Donofrio</name>
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<country name="États-Unis"><region name="État de New York"><name sortKey="Narins, Rhoda S" sort="Narins, Rhoda S" uniqKey="Narins R" first="Rhoda S." last="Narins">Rhoda S. Narins</name>
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<name sortKey="Brandt, Fredric S" sort="Brandt, Fredric S" uniqKey="Brandt F" first="Fredric S." last="Brandt">Fredric S. Brandt</name>
<name sortKey="Lorenc, Z Paul" sort="Lorenc, Z Paul" uniqKey="Lorenc Z" first="Z. Paul" last="Lorenc">Z. Paul Lorenc</name>
<name sortKey="Maas, Corey S" sort="Maas, Corey S" uniqKey="Maas C" first="Corey S." last="Maas">Corey S. Maas</name>
<name sortKey="Mcintyre, Sandi" sort="Mcintyre, Sandi" uniqKey="Mcintyre S" first="Sandi" last="Mcintyre">Sandi Mcintyre</name>
<name sortKey="Monheit, Gary D" sort="Monheit, Gary D" uniqKey="Monheit G" first="Gary D." last="Monheit">Gary D. Monheit</name>
<name sortKey="Smith, R" sort="Smith, R" uniqKey="Smith R" first="R." last="Smith">R. Smith</name>
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</record>

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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. Commentary

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. Commentary

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri