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Split-Face, Randomized, Placebo-Controlled, Double-Blind Study to Investigate Passive Versus Active Dermal Filler Administration

Background QueryHyaluronic acid (HA) is a large polymer increasingly used as dermal filler. HA does not permeate through healthy skin and is administered using various injection techniques. As HA procedures become more popular, the number of complications in facial rejuvenation procedures is likely...

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Published in:Aesthetic plastic surgery 2018-12, Vol.42 (6), p.1655-1663
Main Authors: Freire dos Santos, Mário Jorge, Carvalho, Ricardo, Arnaut, Luis G.
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creator Freire dos Santos, Mário Jorge
Carvalho, Ricardo
Arnaut, Luis G.
description Background QueryHyaluronic acid (HA) is a large polymer increasingly used as dermal filler. HA does not permeate through healthy skin and is administered using various injection techniques. As HA procedures become more popular, the number of complications in facial rejuvenation procedures is likely to increase. Alternative methods may be necessary to satisfy the increasing demand for HA procedures. High-frequency high-intensity ultrasound is a painless and noninvasive method to deliver large molecules to the skin that is expected to deliver HA with visible results. Objective Assess facial rejuvenation with HA delivered with high-frequency high-intensity ultrasound. Methods Fifteen women (mean age 55) willing to participate in a randomized, double-blind, face-split trial with HA and placebo formulations in different sides of the face, were subject to five treatment sessions with high-frequency high-intensity ultrasound. Photographs taken before the procedure and after the last procedure were evaluated by a panel of five experts, blind to which side was treated with the HA or with the placebo. Results The expert panel identified a noticeable facial rejuvenation in the HA side relative to the placebo with a very statistically significant difference between the two sides ( p  
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HA does not permeate through healthy skin and is administered using various injection techniques. As HA procedures become more popular, the number of complications in facial rejuvenation procedures is likely to increase. Alternative methods may be necessary to satisfy the increasing demand for HA procedures. High-frequency high-intensity ultrasound is a painless and noninvasive method to deliver large molecules to the skin that is expected to deliver HA with visible results. Objective Assess facial rejuvenation with HA delivered with high-frequency high-intensity ultrasound. Methods Fifteen women (mean age 55) willing to participate in a randomized, double-blind, face-split trial with HA and placebo formulations in different sides of the face, were subject to five treatment sessions with high-frequency high-intensity ultrasound. Photographs taken before the procedure and after the last procedure were evaluated by a panel of five experts, blind to which side was treated with the HA or with the placebo. Results The expert panel identified a noticeable facial rejuvenation in the HA side relative to the placebo with a very statistically significant difference between the two sides ( p  &lt; 0.0001). Conclusions Administration of HA with high-frequency high-intensity ultrasound is safe and leads to unambiguous facial rejuvenation. Level of Evidence I This journal requires that authors assign a level of evidence to each article. 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All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-620b4cc640852c0718446e2b38feebdc7240b334184b755c66c99340856a23a03</citedby><cites>FETCH-LOGICAL-c372t-620b4cc640852c0718446e2b38feebdc7240b334184b755c66c99340856a23a03</cites><orcidid>0000-0002-3223-4819</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30076447$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Freire dos Santos, Mário Jorge</creatorcontrib><creatorcontrib>Carvalho, Ricardo</creatorcontrib><creatorcontrib>Arnaut, Luis G.</creatorcontrib><title>Split-Face, Randomized, Placebo-Controlled, Double-Blind Study to Investigate Passive Versus Active Dermal Filler Administration</title><title>Aesthetic plastic surgery</title><addtitle>Aesth Plast Surg</addtitle><addtitle>Aesthetic Plast Surg</addtitle><description>Background QueryHyaluronic acid (HA) is a large polymer increasingly used as dermal filler. HA does not permeate through healthy skin and is administered using various injection techniques. As HA procedures become more popular, the number of complications in facial rejuvenation procedures is likely to increase. Alternative methods may be necessary to satisfy the increasing demand for HA procedures. High-frequency high-intensity ultrasound is a painless and noninvasive method to deliver large molecules to the skin that is expected to deliver HA with visible results. Objective Assess facial rejuvenation with HA delivered with high-frequency high-intensity ultrasound. Methods Fifteen women (mean age 55) willing to participate in a randomized, double-blind, face-split trial with HA and placebo formulations in different sides of the face, were subject to five treatment sessions with high-frequency high-intensity ultrasound. Photographs taken before the procedure and after the last procedure were evaluated by a panel of five experts, blind to which side was treated with the HA or with the placebo. Results The expert panel identified a noticeable facial rejuvenation in the HA side relative to the placebo with a very statistically significant difference between the two sides ( p  &lt; 0.0001). Conclusions Administration of HA with high-frequency high-intensity ultrasound is safe and leads to unambiguous facial rejuvenation. Level of Evidence I This journal requires that authors assign a level of evidence to each article. 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subjects Adult
Cosmetic Techniques
Dermal fillers
Dermal Fillers - administration & dosage
Double-Blind Method
Double-blind studies
Esthetics
Female
Humans
Hyaluronic Acid - administration & dosage
Injections, Subcutaneous
Male
Medicine
Medicine & Public Health
Middle Aged
Original Article
Otorhinolaryngology
Patient Satisfaction - statistics & numerical data
Plastic Surgery
Rejuvenation - physiology
Risk Assessment
Ultrasonic imaging
Ultrasonography
title Split-Face, Randomized, Placebo-Controlled, Double-Blind Study to Investigate Passive Versus Active Dermal Filler Administration
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