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Erschienen in: Aesthetic Plastic Surgery 6/2018

03.08.2018 | Original Article

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

verfasst von: Mário Jorge Freire dos Santos, Ricardo Carvalho, Luis G. Arnaut

Erschienen in: Aesthetic Plastic Surgery | Ausgabe 6/2018

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Abstract

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 < 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. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.​springer.​com/​00266.
Literatur
1.
Zurück zum Zitat Stern R, Maibach HI (2008) Hyaluronan in skin: aspects of aging and its pharmacologic modulation. Clin Dermatol 26:106–122CrossRef Stern R, Maibach HI (2008) Hyaluronan in skin: aspects of aging and its pharmacologic modulation. Clin Dermatol 26:106–122CrossRef
2.
Zurück zum Zitat Meyer LJM, Stern R (1994) Age-dependent changes of hyalutonan in human skin. J Invest Dermatol 102:385–389CrossRef Meyer LJM, Stern R (1994) Age-dependent changes of hyalutonan in human skin. J Invest Dermatol 102:385–389CrossRef
3.
Zurück zum Zitat Oh J-H, Kim YK, Jung J-Y, J-e Shin, Kim KH, Cho KH et al (2011) Intrinsic aging- and photoaging-dependent level changes of glycosaminoglycans and their correlation with water content in human skin. J Dermatol Sci 62:192–201CrossRef Oh J-H, Kim YK, Jung J-Y, J-e Shin, Kim KH, Cho KH et al (2011) Intrinsic aging- and photoaging-dependent level changes of glycosaminoglycans and their correlation with water content in human skin. J Dermatol Sci 62:192–201CrossRef
4.
Zurück zum Zitat Sakai S, Yasuda R, Sayo T, Ishikawa O, Inoue S (2000) Hyaluronan exists in the normal stratum corneum. J Invest Dermatol 114:1184–1187CrossRef Sakai S, Yasuda R, Sayo T, Ishikawa O, Inoue S (2000) Hyaluronan exists in the normal stratum corneum. J Invest Dermatol 114:1184–1187CrossRef
5.
Zurück zum Zitat Chiang YZ, Pierone G, Al-Niaimi F (2017) Dermal fillers: pathophysiology, prevention and treatment of complications. J Eur Acad Dermatol Venereol 31:405–413CrossRef Chiang YZ, Pierone G, Al-Niaimi F (2017) Dermal fillers: pathophysiology, prevention and treatment of complications. J Eur Acad Dermatol Venereol 31:405–413CrossRef
6.
Zurück zum Zitat Lee J-H, Kim S-H, Park E-S (2017) The efficacy and safety of HA IDF plus (with lidocaine) versus HA IDF (without lidocaine) in nasolabial folds injection: a randomized, multicenter, double-blind, split-face study. Aesth Plast Surg 41:422–428CrossRef Lee J-H, Kim S-H, Park E-S (2017) The efficacy and safety of HA IDF plus (with lidocaine) versus HA IDF (without lidocaine) in nasolabial folds injection: a randomized, multicenter, double-blind, split-face study. Aesth Plast Surg 41:422–428CrossRef
7.
Zurück zum Zitat Succi IB, da Silva RT, Orofino-Costa R (2012) Rejuvenation of periorbital area: treatment with an injectable nonanimal non-crosslinked glycerol added hyaluronic acid preparation. Dermatol Surg 38:192–198CrossRef Succi IB, da Silva RT, Orofino-Costa R (2012) Rejuvenation of periorbital area: treatment with an injectable nonanimal non-crosslinked glycerol added hyaluronic acid preparation. Dermatol Surg 38:192–198CrossRef
8.
Zurück zum Zitat Pugh WJ, Roberts MS, Hadgraft J (1996) Epidermal permeability—penetrant structure relationships: 3. The effect of hydrogen bonding interactions and molecular size on diffusion across the stratum corneum. Int J Pharm 138:149–165CrossRef Pugh WJ, Roberts MS, Hadgraft J (1996) Epidermal permeability—penetrant structure relationships: 3. The effect of hydrogen bonding interactions and molecular size on diffusion across the stratum corneum. Int J Pharm 138:149–165CrossRef
9.
Zurück zum Zitat Magnusson BM, Anissimov YG, Cross SE, Roberts MS (2004) Molecular size as the main determinant of solute maximum fux across the skin. J Invest Dermatol 122:993–999CrossRef Magnusson BM, Anissimov YG, Cross SE, Roberts MS (2004) Molecular size as the main determinant of solute maximum fux across the skin. J Invest Dermatol 122:993–999CrossRef
10.
Zurück zum Zitat Dragicevic N, Maibach HI (2017) Preface. In: Dragicevic N, Maibach HI (eds) Physical methods in penetration enhancement. Spinger, Heidelberg, p vCrossRef Dragicevic N, Maibach HI (2017) Preface. In: Dragicevic N, Maibach HI (eds) Physical methods in penetration enhancement. Spinger, Heidelberg, p vCrossRef
11.
Zurück zum Zitat Sa GFF, Serpa C, Arnaut LG (2013) Stratum corneum permeabilization with photoacoustic waves generated by piezophotonic materials. J Control Resease 167:290–300CrossRef Sa GFF, Serpa C, Arnaut LG (2013) Stratum corneum permeabilization with photoacoustic waves generated by piezophotonic materials. J Control Resease 167:290–300CrossRef
12.
Zurück zum Zitat Sa GFF, Serpa C, Arnaut LG (2017) Photoacoustic waves as a skin permeation enhancement method. In: Dragicevic-Curic N, Maibach HI (eds) Physical methods in penetration enhancement. Springer, Heidelberg, pp 175–191CrossRef Sa GFF, Serpa C, Arnaut LG (2017) Photoacoustic waves as a skin permeation enhancement method. In: Dragicevic-Curic N, Maibach HI (eds) Physical methods in penetration enhancement. Springer, Heidelberg, pp 175–191CrossRef
13.
Zurück zum Zitat Bommannan D, Menon GK, Okuyama H, Elias PM, Guy RH (1992) Sonophoresis. II. Examination of the mechanism(s) of ultrasound-enhanced transdermal drug delivery. Pharm Res 9:1043–1047CrossRef Bommannan D, Menon GK, Okuyama H, Elias PM, Guy RH (1992) Sonophoresis. II. Examination of the mechanism(s) of ultrasound-enhanced transdermal drug delivery. Pharm Res 9:1043–1047CrossRef
14.
Zurück zum Zitat Park HK, Kim E, Kim J, Ro Y, Ko J (2015) High-intensity focused ultrasound for the treatment of wrinkles and skin laxity in seven different facial areas. Ann Dermatol 27:688–693CrossRef Park HK, Kim E, Kim J, Ro Y, Ko J (2015) High-intensity focused ultrasound for the treatment of wrinkles and skin laxity in seven different facial areas. Ann Dermatol 27:688–693CrossRef
Metadaten
Titel
Split-Face, Randomized, Placebo-Controlled, Double-Blind Study to Investigate Passive Versus Active Dermal Filler Administration
verfasst von
Mário Jorge Freire dos Santos
Ricardo Carvalho
Luis G. Arnaut
Publikationsdatum
03.08.2018
Verlag
Springer US
Erschienen in
Aesthetic Plastic Surgery / Ausgabe 6/2018
Print ISSN: 0364-216X
Elektronische ISSN: 1432-5241
DOI
https://doi.org/10.1007/s00266-018-1208-9

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