Single-Arm Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid

Goldberg, David J.; Guana, Adriana; Volk, Andrea V.; Daro-Kaftan, Elizabeth

doi:10.1111/dsu.12164

Cited by 59 publications

(49 citation statements)

References 13 publications

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“…While the structure of the suture itself is designed to serve the mechanical function of supporting tissue, the physiochemical properties of the resident PLLA/PLGA are thought to serve the complementary function of volume restoration through stimulation of collagen. The collagen‐stimulating ability of PLLA is well documented, and there are multiple clinical reports of absorbable suspension suture outcomes that include patient‐ and physician‐reported improvements in volume and contour, as well as improvements in skin quality . Further, a similar product with a PLLA monofilament and PLGA cones (marketed as Silhouette Soft in Europe [Sinclair Pharma]) has been shown to induce type I collagen, effectively doubling the diameter of the PLLA monofilament at 12 months via encapsulation .…”

Section: Introductionmentioning

confidence: 99%

Stimulation of collagenesis by poly‐L‐lactic acid (PLLA) and ‐glycolide polymer (PLGA)‐containing absorbable suspension suture and parallel sustained clinical benefit

Goldberg

2020

J of Cosmetic Dermatology

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Background Though the collagen‐stimulating capacity of poly‐L‐lactic acid (PLLA) is well established, no data are available on collagen stimulation by the PLLA/PLGA within absorbable suspension sutures used for tissue repositioning. Aims To characterize collagen stimulation by absorbable suspension sutures through examination of patient biopsies and assess severity of nasolabial folds (NLF) over time. Patients/Methods Single‐center, open‐label, prospective study of 25 healthy volunteers treated with absorbable suspension sutures for descent of midface tissues. Punch biopsies were collected and evaluated for total collagen content. Subject and investigators evaluated NLF severity using the Nasolabial Fold Wrinkle Assessment Score (NLF‐WAS). Seventeen of 25 patients completed the collagenesis portion of the study. Results Collagen deposition was apparent at day 90 and increased significantly compared with baseline at days 180 and 270 and between days 90 and 180. Subject‐ and investigator‐reported NLF‐WAS were significantly improved at all post‐treatment time points through day 270. Conclusions Absorbable suspension sutures stimulate collagen in areas immediately adjacent to the path of the PLLA/PLGA monofilament and cones, providing mechanistic support for improvement in appearance observed in clinical studies. This neocollagenesis, coupled with repositioning by the suture's cones, makes absorbable suspension sutures a valuable tool for patients seeking facial rejuvenation.

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Section: Introductionmentioning

confidence: 99%

Stimulation of collagenesis by poly‐L‐lactic acid (PLLA) and ‐glycolide polymer (PLGA)‐containing absorbable suspension suture and parallel sustained clinical benefit

Goldberg

2020

J of Cosmetic Dermatology

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“…It is a synthetic polymer similar to absorbable suture material, which stimulates collagen synthesis through a foreign-body reaction. A statistically significant increase in the mean level of collagen was documented 6 months after PLLA injection [16].…”

Section: Poly-l-lactic Acidmentioning

confidence: 81%

“…According to a blinded evaluator, 77 % of subjects at week 8 and 59 % of subjects at week 24 following upper and lower lip injections were considered to have a one-grade or greater change on the 5-point Medicis Lip Fullness Scale. For subjects receiving additional injections for correction of perioral rhytides, there was a statistically significant and clinically meaningful improvement in perioral rhytides as assessed by the blinded evaluator at weeks [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. No serious adverse events occurred.…”

Section: Restylane ò Silkmentioning

confidence: 99%

Dermal Fillers: An Update

2015

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Injection of dermal fillers is the second most frequent nonsurgical cosmetic procedure performed in the USA. Dermal fillers are an option in the treatment of volume deficiency, scars, and rhytides; facial sculpting; facial contouring; and augmentation of specific anatomical sites such as the lips. The number of injectable dermal fillers available on the market increases yearly. Dermatologists and cosmetic surgeons should regularly review treatment options to provide patients with safe and effective filler options. This paper extensively reviews the properties of the available fillers, such as their rheology, longevity, and adverse effects, and how these properties affect the choice of filler agent for a particular patient or a particular site. Also, trends in dermal filler injections are discussed.

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“…Currently, filler injection for skin rejuvenation has become a standard therapeutic method as a noninvasive aesthetic treatment. Although hyaluronic acid is the most commonly used filler material, new biodegradable collagen stimulatory filler materials such as CaHA, PLLA, and PCL have emerged …”

Section: Discussionmentioning

confidence: 99%

“…Although hyaluronic acid is the most commonly used filler material, new biodegradable collagen stimulatory filler materials such as CaHA, PLLA, and PCL have emerged. 6,7 Polydioxanone is a colorless, crystalline, and absorbable polymer that is particularly used in the preparation of surgical sutures. PDO has good flexibility and tensile strength with suitable biocompatibility and minimal inflammation compared to other suture materials.…”

Section: Discussionmentioning

confidence: 99%

Biostimulatory effects of polydioxanone, poly‐d, l lactic acid, and polycaprolactone fillers in mouse model

Kwon

Han

Yeo

et al. 2019

J of Cosmetic Dermatology

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Summary Background Numerous fillers are increasingly used for augmentation of volume loss and relaxation of facial wrinkles. Collagen stimulators are the latest next‐generation dermal fillers that can induce neocollagenesis. To investigate biophysical characteristics, safety, and efficacy of newly developed polydioxanone (PDO) filler in comparison with poly‐l lactic acid (PLLA) and polycaprolactone (PCL) fillers. Methods In vitro assay, morphology of particles, and rheological property of fillers were measured. A total of 24 female hairless mice (SKH1‐Hrhr) were randomly divided into three groups and injected with PDO, PLLA, or PCL fillers. Durability of fillers was assessed at 0, 3 days, and 1, 4, 8, 12 weeks after injection using folliscope and PRIMOS. To determine biocompatibility and neocollagenesis, histologic evaluation was performed at 1, 4, 8, and 12 weeks after injection. Efficacy was also evaluated based on skin surface roughness changes using PRIMOS in a hairless mouse photoaging model. Results In the particle morphology test, PDO microspheres had an irregular surface and were spherical and uniformly sized. PDO filler demonstrated similar neocollagenesis and inflammatory response to other collagen stimulators. PDO filler showed better biodegradability than PLLA and PCL fillers. In the hairless mouse photoaging model, there was a statistically significant decrease in skin surface roughness after PDO filler injection. Conclusions Our data suggest that newly developed collagen stimulating PDO filler might be a safe and effective option for correction of volume loss and rejuvenation of photoaging skin.

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Single-Arm Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid

Abstract: Results of this study in humans found statistically significant stimulation of collagen type I with no or mild inflammatory response after administration of injectable PLLA.

Cited by 59 publications

References 13 publications

Stimulation of collagenesis by poly‐L‐lactic acid (PLLA) and ‐glycolide polymer (PLGA)‐containing absorbable suspension suture and parallel sustained clinical benefit

Stimulation of collagenesis by poly‐L‐lactic acid (PLLA) and ‐glycolide polymer (PLGA)‐containing absorbable suspension suture and parallel sustained clinical benefit

Dermal Fillers: An Update

Biostimulatory effects of polydioxanone, poly‐d, l lactic acid, and polycaprolactone fillers in mouse model

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