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Sculptra®—History and how it is best used today
Abstract
Introduction
Sculptra® is an injectable biostimulatory soft tissue filler containing microparticles of poly‐L‐lactic acid (PLLA) that is FDA‐approved for the correction of HIV‐associated facial lipoatrophy and nasolabial fold contour deficiencies and other facial wrinkles in immunocompetent patients. Injectable PLLA has been shown to provide gradual improvement in cutaneous thickness by inciting a subclinical inflammatory response that stimulates increased collagen deposition in the dermis, with results lasting up to 2 years.
Discussion
The utilization of Sculptra® in aesthetics has expanded to many off‐label indications including panfacial revolumization, improvement in skin quality, and use in various non‐facial sites such as the neck/décolleté, abdomen, arms, hands, thighs, and gluteal area. Clinical experience and scientific investigation have driven changes in the way PLLA is used. Simpler methods of product preparation, improved injection techniques, and attention to appropriate patient selection have led to improved outcomes and ease of use.
Conclusion
PLLA's long safety history and ability to produce subtle yet significant results through a biostimulatory mechanism make it an attractive and versatile option for cutaneous volume augmentation.
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The number of aesthetic procedures performed worldwide continues to grow together with an increase in the population seeking the restoration or preservation of a youthful appearance. Requests for non-surgical body rejuvenation are increasing. Patients are looking for safe and effective minimally invasive aesthetic procedures. Soft-tissue dermal fillers can meet these expectations. Based on the beneficial outcomes of these treatments in many facial areas, a new trend is developing to target body areas. Different dermal fillers are available and include collagen stimulators initially developed to restore facial volume. Furthermore, they are associated with long-lasting efficiency, a high level of patient satisfaction and a good safety profile, with mainly minor adverse events reported. In appropriate conditions of use, they are now used for body rejuvenation in clinical practice. Their use is expanding and allows addressing various issues including volume loss, skin laxity, cellulite, striae distensae and wrinkles. This review focuses on poly-L-lactic acid (PLLA), used in the first collagen stimulator and one of the most investigated in facial and in off-facial body applications. The available published data, although still limited, are presented by body area, neck and chest, buttocks, abdomen, upper arms, thighs, knees, and hands. Key features of the concerned zones and the main clinical signs affecting the body part as well as the injection modalities are provided along with the aesthetic results. This represents the state of the art on which to base further developments necessary for optimal and safe outcomes of treatment with the PLLA-based collagen stimulators and others in this class for body rejuvenation.
Background:
There is a significant emphasis on minimally invasive whole-body rejuvenation throughout the world. Recently, gluteal aesthetics have become an increasingly common patient concern. Although the application of poly-L-lactic acid (PLLA) to the face is already well known, there are relatively fewer publications on its use in other corporeal regions. This study aims to extend previous findings by evaluating the efficacy and safety of PLLA in the treatment of contour (including lifting) deformities of the buttock region.
Methods:
This was a prospective, multicenter (3 sites), single cohort, open-label clinical trial. Thirty female subjects were treated with PLLA in the bilateral buttocks, with three treatment sessions, each spaced one month apart and followed for six months after completion of the treatment regimen. At each visit, various safety and clinical efficacy parameters were collected, these included: Global Assessment of Improvement Scale (GAIS), subject satisfaction, skin hydration, elasticity, scaliness, roughness, and 3-dimensional imagery.
Results:
Six months following the last treatment, 84.00% of patients were rated as having “improved” or more on the physician assessed GAIS, accompanied by a 96.00% patient satisfaction rate. Approximately three vials of PLLA, per buttock and treatment were used. There were no serious adverse events throughout the duration of the trial, nor adverse events related to the investigational device. The most common subject-reported adverse events included pain during treatment (Mean: 70.97%) and bruising (Mean: 28.80%). Objective improvements were persistent after treatment in measurements of skin elasticity (improved 63.5% - 82.5% from weeks 16-32), hydration (increased ~11 Corneometer® units by week 16), roughness (decreased 36.95% at week 32), and scaliness (desquamation; decreased 60.41% at week 32).
Conclusions:
PLLA is safe and effective for the indication of buttock contouring and improving parameters of skin health. PLLA can provide long-lasting effects with a high level of patient and physician satisfaction. J Drugs Dermatol. 2022;21(3):304-308. doi:10.36849/JDD.5924.
Injectable poly-L-lactic acid (PLLA) is a biodegradable synthetic polymer that stimulates collagen production, leading to gradual volume restoration. The treatment of sagging skin in body areas is still a big challenge, as there are few aesthetic procedures aiming to improve it. This article provides recommendations on the use of PLLA in the treatment of skin laxity in off-face areas, as the neck, décolletage, arms, abdomen, buttocks, and thighs, including the patient selection, product preparation, and injection techniques. The use of PLLA is a promising method for the treatment of skin laxity in corporal areas, improving body contour and appearance. Further investigation is needed to better understand the efficacy and durability of PLLA in non-facial indications and to provide the best evidence for optimal patient outcomes.
J Drugs Dermatol. 2019;18(9):929-935.
The authors present a reproducible and effective technique utilizing poly-L-lactic acid for panfacial revolumization. The variable dilution ratios, reconstitution times, injection techniques and rates of nodule formation with poly-L-lactic acid can be intimidating to even experienced injectors. While there is no single cookie-cutter approach to facial volumization, this 6-step "Precise Sculpt" technique can be used as a template to reliably achieve optimal results while minimizing the risk of adverse events. J Drugs Dermatol. 2016;15(12):1550-1556.
Granulomatous reactions to poly-l-lactic acid (PLLA)-based filler have been described previously. Neither the biological background of these partly late-onset reactions or the desired augmenting effect of PLLA has been studied to date. Histological studies have revealed foreign body reactions and foreign body giant cell formation.
The aim of this study was to increase our knowledge about the biological mechanisms behind the augmenting effect of PLLA-based filler.
We characterised the cell infiltrate and collagen type of PLLA-treated tissue by immunofluorescence staining. The expression of genes related to collagen metabolism was determined.
CD68(+) macrophages were found next to PLLA. CD90(+) fibroblasts were found alongside. αSMA-positive structures indicated myofibroblasts and neovascularisation. Substantial collagen type III deposition was detected next to PLLA particles and collagen type I was found at the periphery of PLLA encapsulations. mRNA expression for collagen type I and III transcripts, as well as for TGFβ1 and TIMP1, was upregulated significantly.
PLLA-induced augmentation is most likely based on capsule formation orchestrating macrophages, (myo-)fibroblasts, and collagen type I and III fibres. We observed considerably slower degradation of PLLA particles than described previously. Thus PLLA particles were still retrievable 28 months after subcutaneous application.
Copyright © 2015 Japanese Society for Investigative Dermatology. Published by Elsevier Ireland Ltd. All rights reserved.
Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device.
We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles.
In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms.
Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13.
Mostly white women and subjects with Fitzpatrick skin types II and III were included.
Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.
Background
Patients with connective tissue disease (CTD) often suffer from facial cutaneous defects and resultant facial asymmetry. Unfortunately, these issues have been known to be difficult-to-treat, and concern exists regarding the use of cosmetic procedures in this patient population due to the theoretical risk of disease flare-up or reactivation. Injectable poly-L-lactic acid (PLLA) is one type of filler that has been used to treat skin atrophy in patients with morphea and lupus erythematous panniculitis. However, overall, there is a dearth in literature regarding the safety and efficacy of PLLA filler in patients with CTDs.
Aims
This case series intends to evaluate the safety and efficacy of PLLA filler in treating facial atrophy in patients with CTDs.
Patients/Methods
Three patients underwent various treatment courses involving the use of PLLA filler to treat facial atrophy.
Results
Two patients demonstrated significant improvement in facial atrophy following their treatment course. No patient experienced reactivation or exacerbation of their CTD following PLLA injection.
Conclusion
PLLA filler appears to have good viability as a safe and potentially effective treatment for facial atrophy in patients with CTDs.
Background:
Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications.
Objective:
The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women.
Methods:
31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings.
Results:
At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred.
Conclusion:
Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5380.
INTRODUCTION
Clinical data on body contouring with injectable poly‐L‐lactic acid are sparsely reported in published literature. This study describes the lead author’s clinical experience using injectable poly‐L‐lactic acid for body contouring in various anatomic locations.
METHODS
20 consecutive patients undergoing body contouring treatments with poly‐L‐lactic acid were prospectively followed. All treatments were performed at a single clinic between February 2017 and February 2019. Treatment details such as reconstitution, injection volume, and dosage were documented. Treatment response was assessed independently by patients and the treating physician. Adverse events were recorded.
RESULTS
Twenty patients (85% women) received injectable poly‐L‐lactic acid for body contouring treatments such as buttocks volumization, cellulite, and skin quality treatment. In most patients (65%), poly‐L‐lactic acid was administered to correct post‐surgical soft tissue deformities. Overall, patients had a mean of 5.1 treatment sessions in a mean of 1.4 anatomic locations. The most commonly treated anatomic locations were buttocks (58% of treatment sessions), thighs (20%), and abdomen (9%). Dosage and injection volume varied between patients depending on anatomic location and desired outcome. Most treatment sessions (86%) resulted in improvement of the treated area. Adverse events included bruising, edema, numbness, and tenderness. Nodule formation was recorded for one patient (5%).
CONCLUSION
According to the lead author’s clinical experience, poly‐L‐lactic acid injection is well tolerated and can achieve good aesthetic outcomes when used for body contouring in appropriate patients. Preliminary data suggests that poly‐L‐lactic acid injection may be a viable nonsurgical technique for correcting post‐surgical soft tissue deformities.
Background:
Dermal fillers such as hyaluronic acid, poly-l-lactic acid, and polymethyl-methacrylate are often used to treat cutaneous defects such as lipoatrophy. However, concern exists regarding their use in patients with a connective tissue disease (CTD) because of a theoretical risk of disease reactivation or exacerbation. Evidence regarding their use in patients with CTD also remains limited.
Objective:
This review intends to summarize and evaluate the available literature regarding the use of dermal fillers in patients with CTD.
Materials and methods:
A literature search until May 2020 was conducted through PubMed, Ovid MEDLINE, and Ovid Embase to identify articles discussing the treatment of cutaneous defects secondary to CTD. Articles discussing the use of autologous fat transfer alone were excluded.
Results:
Twenty-three articles were reviewed. The amount of available evidence varies between the type of CTD and type of filler with morphea having the most published evidence out of the CTDs discussed and hyaluronic acid having the most published evidence out of the fillers discussed. Most studies demonstrated positive results with no report of disease reactivation or exacerbation.
Conclusion:
Despite limited available evidence, dermal fillers seem to be safe as an adjunctive treatment for cutaneous defects in patients with CTD.
Background:
Poly-L-lactic acid (PLLA) is a biodegradable, synthetic polymer that stimulates collagen production and can improve skin quality, volume, and thickness. The current reconstitution procedure for Sculptra, a PLLA-containing injectable device involves 2 hours standing time before use.
Objective:
To evaluate and validate an immediate-use procedure for reconstituting a PLLA-containing injectable device.
Methods and materials:
Three batches of the product were shaken for 1 minute immediately after reconstitution with 8 mL of sterile water. Different physicochemical tests including viscosity, concentration of excipients (sodium carboxymethylcellulose and mannitol), pH, and particle size distribution were performed for standing times 0, 2, 24, and 72 hours after immediate shaking, and compared with the standard 2 hours standing time before shaking. The recovery and stability of optional addition of 1 mL of 2% lidocaine hydrochloride was also assessed.
Results:
All physiochemical parameters evaluated were equivalent, regardless of reconstitution procedure, showing that shaking vigorously for 1 minute dissolves the excipients of the product properly without a required standing time and with no impact to the PLLA particles. There were no differences in lidocaine hydrochloride content of suspensions after 0 and 72 hours.
Conclusion:
The PLLA-containing product can be used immediately after reconstitution including vigorous shaking, as shown from physicochemical analyses. Optional addition of lidocaine hydrochloride is feasible. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5228.
Lupus erythematosus panniculitis (LEP), also referred to as lupus profundus, is an inflammatory disease that affects 2% to 3% of individuals with LE and can lead to cosmetic disfigurement due to significant lipoa- trophy affecting the face, upper arms, hips, and trunk. We report on the successful treatment of facial lipoa- trophy secondary to LEP, in a patient with treated and quiescent disease, using poly-L-lactic acid (PLLA) monotherapy achieving cosmetic improvement and demonstrating safety of PLLA use in the setting of connective tissue disease (CTD).
Unstructured abstract:
Morphea and systemic sclerosis are inflammatory, sclerosing disorders. Morphea primarily affects the dermis and subcutaneous fat, while systemic sclerosis typically involves the skin and internal organs. Functional impairment and cosmetic disfigurement are common in both diseases. Treatment options to mitigate disease progression remain limited.1,2 Both functional impairment and cosmetic deficits negatively impact quality of life and psychological well-being in this patient population.
Background:
There is a growing demand for procedures to treat cellulite. Subcision™ is widely used for cellulite correction, and injectable poly-L-lactic acid (PLLA) has been shown to be an effective option for various body conditions.
Aims:
Present the results of combining Subcision™ plus PLLA, in the same session, in patients with cellulite and flaccidity.
Patients/methods:
Twenty-four women underwent Subcision™ followed by PLLA injections. An expert panel of dermatologists evaluated before and after photographs according to Global Aesthetic Improvement Scale (GAIS). Patients also answered a satisfaction questionnaire.
Results:
The author describes the results, as well as number of sessions and dose used. The most frequent GAIS score was "great improvement." No nodules or granulomas appeared in the treated areas.
Conclusion:
The combination of Subcision™ plus PLLA, in the same treatment session, promotes safe and desirable results for cellulite associated with flaccidity.
Parry−Romberg syndrome (PRS), also known as “progressive facial hemiatrophy”, is a rare degenerative condition of the face. It is characterized by progressive but self‐limiting unilateral wasting of facial skin, including subcutaneous fat, muscle, and, in some cases, bone. Cosmetic correction of hemiatrophy is usually delayed until its progression has become obvious.1 Different treatment modalities, including free tissue transfer, pedicled flaps, and autologous tissue grafts,1,2 have been attempted with various results.
Background:
Poly-L-lactic acid (PLLA) is an injectable filler used for restoring facial fat volume loss.
Objective:
To evaluate the effect of repeated PLLA injections on skin quality.
Methods:
Forty healthy women were enrolled in this randomized, controlled, double-blind, multicenter study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections, into both sides of the face. Follow-up visits were at 6, 9, and 12 after the last treatment. Assessments included biophysical measuring instruments, live ratings, patient questionnaires, and rating of standardized pictures by a blinded evaluator.
Results:
At the 12-month follow-up, there was a statistically significant increase of skin elasticity and hydration in PLLA-treated subjects and a decrease in transepidermal water loss in both groups. Pigmentation, erythema, and pore size were significantly decreased, whereas radiance and smoothness were significantly increased at 12 months per blinded investigator rating in this group. No treatment-related adverse events occurred.
Conclusion:
Repeated PLLA treatments may improve skin quality in a time-dependent manner.
Background:
Perioral rhytides are a common complaint among dermatologic patients and can be notoriously stubborn and resistant to therapy.
Objective:
We aimed to assess the safety of fractional ablative laser-assisted delivery of topical poly-L-lactic acid (PLLA) suspension in the treatment of upper cutaneous lip rhytides.
Materials and methods:
Prospective, single-arm, rater-blinded trial. Ten subjects with moderate to severe upper lip rhytides underwent 3 bimonthly treatments of low-density fractional carbon dioxide laser followed by topical application of PLLA suspension. Wrinkle severity before and after treatment was analyzed using computer-generated analyses. Blinded raters and subjects assessed improvement of wrinkles after treatment using the Global Aesthetic Improvement Scale (GAIS) (scores ranging from -3 to 3). Adverse events were recorded at each visit.
Results:
Treatments were well tolerated. Other than expected post-laser erythema, no unanticipated adverse events were noted. After 3 treatments, the severity of upper lip wrinkles decreased by an average of 47% (p < .05) as calculated by computer-generated image analyses. Blinded raters and subjects rated wrinkles as much improved after 3 treatments (score of 2 on the GAIS).
Conclusion:
Laser-assisted delivery of PLLA is a safe and possibly effective treatment for upper lip rhytides.
Poly-L-lactic acid (PLLA) is a synthetic, biocompatible, biodegradable polymer. For soft-tissue augmentation, the size and chemical attributes of the PLLA microparticles are central to this agent’s ability to promote a subclinical inflammatory response that stimulates deposition of collagen in the extracellular matrix. The resultant restoration of facial volume occurs in a controlled, predictable manner and is long lasting. The unique physiochemical and biostimulatory properties of PLLA differentiate it from other available treatments and are the foundation of the unique treatment methodology required for optimal results.
p>Injectable soft-tissue augmentation agents have become popular alternatives to surgical procedures for the aging face and body. In contrast to temporary, space-occupying replacement fillers such as collagen-based and hyaluronic acid products, poly-l-lactic acid (PLLA) has been demonstrated to gradually promotes deposition of collagen via a biostimulatory response, with therapeutic effects lasting approximately two years. In 2004, the FDA approved its use for rejuvenation of facial contours secondary to lipoatrophy associated with antiretroviral therapy for HIV infection. By 2009 PLLA was FDA-approved for the correction of nasolabial fold contour deficiencies and other lines and wrinkles. There have since been limited but promising results with off-label use of PLLA for nonfacial volumization as well, including the hands, neck/décolleté, abdomen, and gluteal area. The objective of this article is to review clinical evidence, current trends, and technical considerations for the use of PLLA for nonfacial, body rejuvenation.
J Drugs Dermatol. 2017;16(5):489-494.
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BACKGROUND AND OBJECTIVE: Acne scars may negatively impact quality of life. The purpose of this study was to collect preliminary data on the efficacy and safety of injectable poly-L-lactic acid (PLLA, Sculptra, Dermik Laboratories) for the treatment of acne scars.
METHODS: Twenty subjects aged 42.4±10.7 years (10 men, 10 women) with facial scars resulting from moderate to severe acne or varicella participated in this single-center, open-label prospective study. The primary end point was the resolution of the acne or varicella scars. Secondary end points were the physician and subject assessments of scar improvement. PLLA reconstituted with 5 mL of sterile water was injected serially at or near the sites of the acne scars without topical anesthesia.
RESULTS: Investigator-assessed reductions in acne scar size and severity were significant (p<.0001) during the course of seven treatments. Subject-rated reduction in scar severity was also significant (p=.0078). Subject satisfaction with treatment trended toward an increase with each treatment session and approached significance (p=.0899). Adverse events were limited to depression (n=1) not related to the treatment.
CONCLUSION: Injectable PLLA as used in this investigation appears to correct the types of acne scars treated in this study without serious adverse effects.
A survey of Sculptra® Aesthetic injectors was conducted to understand how the product is being currently reconstituted and injected. Questions were asked of injectors to understand their reasons for choice and volume of diluent(s), additions, and time for the reconstitution process. These results are discussed in the context of the past history of the product over the last decade, with a focus on adverse events such as papules and nodules.
J Drugs Dermatol. 2016;15(6):759-762.
Background:
Laser-assisted drug delivery (LADD) is an evolving new therapy with many possible applications as a highly targeted customizable method for distribution of drugs within the skin. LADD offers the advantages of accessibility, noninvasiveness, compliance, safety, and effectiveness.
Objective:
To review the available literature regarding LADD.
Methods:
A MEDLINE search was performed on LADD from 1989 to 2015, and the results are summarized. Practical applications of these procedures are also discussed.
Results:
Reports of the use of ablative, nonablative, and fractional lasers as a means to increase cutaneous permeation of the topical application of medications and cosmeceuticals were found. The focus of the review was to demonstrate the variety of topical treatments that have been used with the LADD method and the multitude of future studies needed to fully characterize the best application of this evolving technology.
Conclusion:
The most comprehensive review in the literature to date on LADD is provided. Further studies are needed to fully evaluate the safety, dosing, side effects, and results.
Hill and valley scarring is 1 of 3 atrophic scar types that occur as a result of acne, becoming more apparent with facial skin aging. Treatment includes resurfacing techniques and the use of injectable fillers. Poly-L-lactic acid is an injectable collagen builder that has been used for the treatment of HIV-associated lipodystrophy and cosmetic enhancement.
To determine the degree of correction attainable with poly-L-lactic acid and safety findings for the treatment of hill and valley acne scarring.
Poly-L-lactic acid was injected over 3 to 4 serial treatments at 4-week intervals in 22 subjects in this single-arm, unblinded, open-label Phase II study. Efficacy was determined by physician, blinded evaluator, and subject assessment of scar improvement using Likert scales, comparing photographs taken by 3 camera systems at treatment visits 2 to 4 and follow-up to baseline. Subjects also assessed treatment satisfaction.
Percentage of patients with much to excellent improvement using the most sensitive camera system (VISIA-CR) ranged from 45.5% to 68.2%. Subject treatment satisfaction scores increased by 44%. One patient experienced a palpable nonvisible nodule. No subjects discontinued treatment.
Injectable poly-L-lactic acid facilitated improvement in hill and valley acne scarring and was well tolerated.
Background: In the absence of currently available therapy to manage facial lipoatrophy, strategies used to compensate for facial fat loss warrant clinical evaluation. Methods: The goal of this open-label, single-arm, pilot study was to evaluate the efficacy and safety of facial injections of poly-L-lactic acid (PLA) (New-Fill)® in HIV-infected patients with severe facial lipoatrophy. Patients received four sets of injection at day 0 and then every 2 weeks for 6 weeks. Patients were evaluated by clinical examination, facial ultrasonography, and photography at screening and at weeks 6, 24, 48, 72, and 96. Results: Fifty patients were enrolled. At entry, the median facial fat thickness was equal to zero (range, 0.0–2.1 mm). The median total cutaneous thickness (TCT) increased significantly from baseline : +5.1 mm (range, 2.2–8.6 mm) at week 6, +6.4 mm (range, 3.1–9.1 mm) at week 24, +7.2 mm (range, 4.2–9.6 mm) at week 48, +7.2 mm (range, 3.5–9.6 mm) at week 72 and +6.8 mm (range, 3.9–10.1 mm) at week 96 (P < 0.001). The proportion of patients with TCT > 10 mm was observed in 19% at week 6, 41% at week 24, 61% at week 48, 52% at week 72 and 43% at week 96. In 22 (44%) patients, palpable but non-visible subcutaneous micronodules were observed with a spontaneous resolution in six patients at week 96. Conclusion: The benefit of PLA for the correction of the facial lipoatrophy in HIV-infected patients was clearly demonstrated, with an evident aesthetic and quality of life improvement. The efficacy, safety profile, and the simplicity of the injection schedule of PLA make this filling material a potentially attractive treatment.
Over the last few years, there have been a number of important changes in how we appreciate and understand the aging face. Volume loss is now recognized as a major component of facial aging. Treatment options that replace lost volume are increasingly used for recontouring and rejuvenation of the aging face. In this review we present and discuss the European Expert Group recommendations on the ideal use of the unique collagen stimulator, poly-L-lactic acid (PLLA, Sculptra®, Sinclair Pharmaceuticals) for facial rejuvenation lasting up to 25 months. Optimal results are achieved based on a detailed knowledge of facial anatomy, correct treatment procedure, specifically the right dilution, the correct injection technique, as well as appropriate patient aftercare. PLLA is an effective and safe collagen stimulator that treats the whole face. PLLA is simple to use, provides the foundation for facial rejuvenation, is easy to combine with other treatments, and gives long-lasting effects with a high level of patient satisfaction.
J Drugs Dermatol. 2014;13(9):1057-1066.
Background:
Atrophic scars represent a loss of collagen and a challenging reconstructive dilemma with disappointing traditional treatments.
Objective:
To study the safety and efficacy of the treatment of atrophic scars using an ablative fractionated CO2 laser and topical poly-L-lactic acid (PLLA) immediately after to improve atrophic scars.
Materials and methods:
This was an uncontrolled, institutional review board-approved, prospective study evaluating the treatment of atrophic scars. Four blinded dermatologists evaluated a total of 20 photographs taken at baseline and 3 months after the laser and PLLA treatments using the Modified Manchester Scar Scale. Four criteria were evaluated: (1) overall improvement, (2) improvement in scar atrophy, (3) improvement in scar color/dyschromia mismatch, and (4) improvement in scar contour.
Results:
All 4 observers accurately identified 76 of the 80 "before" and "after" photographs. Therefore, the blinded evaluating physicians agreed that at the 3-month follow-up visit, 95% of the scars had improved. Each criterion demonstrated an average improvement of at least 33%.
Conclusion:
The combination of using an ablative fractional CO2 laser and PLLA in the treatment of atrophic scars has a synergistic effect on their inherent properties in up-regulating new collagen synthesis to improve atrophic scars.
Poly-L-lactic acid (PLLA) was approved for use in Europe in 1999. In the United States, it was approved by the Food and Drug Administration in 2004 for the treatment of facial lipoatrophy associated with human immunodeficiency virus, and in 2009 for cosmetic indications in immune-competent patients. The need for consistent, effective PLLA usage recommendations is heightened by an increased consumer demand for soft tissue augmentation and a shift toward a younger demographic. Over the past 14 years, considerable experience has been gained with this agent, and we have come to better understand the clinical, technical, and mechanistic aspects of PLLA use that need to be considered to optimize patient outcomes. These consensus recommendations regarding patient selection, proper preparation and storage, optimal injection techniques, and other practical considerations reflect the body of evidence in the medical literature, as well as the collective experience of this author group.
J Drugs Dermatol. 2014;13(suppl 4):s44-s51.
Unlabelled:
With the recognition of the key role of volume loss in the facial aging process, injectable dermal fillers and volumizers have become increasingly important treatment options for recontouring and rejuvenating the aging face. While replacement fillers effectively correct individual lines and wrinkles, volumizing agents that replace collagen provide a longer-lasting, volume-based alternative. Poly-L-lactic acid (PLLA) has been shown to increase dermal thickness and volume for up to 2 years and beyond. Although early clinical use of this agent in patients with HIV-associated facial lipoatrophy was associated with a significant rate of nodule or papule formation, subsequent experience has helped define the proper reconstitution volumes and injection techniques for optimizing results and minimizing nodule/papule formation. While injectable PLLA has been used successfully for rejuvenation of most facial areas, increasing experience suggests that it is a versatile agent capable of providing aesthetic enhancement in multiple areas of the body, including the dorsum of the hands, the décolleté, the neck, the buttocks, the medial ankles, and acne scars. Although the current published experience in these areas is limited, further studies and clinical use of injectable PLLA will clarify the potential of this agent as a minimally invasive alternative and/or adjunct to surgery for restoring volume loss in multiple anatomic areas.
Level of evidence v:
This journal requires that authors assign a level of evidence to each article.
Loss of facial volume due to skeletal resorption and facial fat redistribution is considered a primary cause for increased skin folding and sagging associated with aging. The objective of this review is to examine how use of injectable poly-L-lactic acid (PLLA) for correction of human immunodeficiency virus (HIV)-associated facial lipoatrophy supports wider use in treating aging-related facial changes given its approval for aesthetic use. A literature review of studies evaluating injectable PLLA for the treatment of HIV-associated or aging-related contour deficiencies was conducted via MEDLINE, supplemented by the author's clinical experience. In clinical trials of HIV-related facial lipoatrophy, injectable PLLA increased dermal thickness for up to 96 weeks. Another study showed significant improvements in aging-related nasolabial fold wrinkles that lasted up to 25 months. Understanding differences in the use of injectable PLLA between patients with HIV and those with aging-related facial changes will help physicians optimize patient treatment.
Sculptra (Sanofi-Aventis, Bridgewater, NJ) was approved by the U.S. Food Drug Administration (FDA) for use in HIV-related lipoatrophy in 2004 and received FDA approval for cosmetic use as Sculptra Aesthetic in July 2009. The authors have experience with this product in both applications. The purpose of this article is to share their methodology. Both soft-tissue and supraperiosteal injections will be illustrated and discussed in detail. Much progress has been made in the last decade in understanding of volume changes in all structural layers of the face, and this will be briefly reviewed as it is pertinent to the methodology. Equally important is the issue of patient selection. Ultimately, the quality of the result, and the time and amount of product that it takes to achieve that result, is contingent on the quality of tissues with which one starts. A very lipoatrophic patient, or an elderly patient with advanced volume loss and poor skin integrity is more difficult to correct-requiring more product and more treatment sessions (with any product) than that needed for a younger or plumper face.
Poly-L-lactic acid, a synthetic biodegradable polymer, is available as an injectable intradermal implant for use in the correction and restoration of the signs of facial lipoatrophy in patients with HIV infection.
In a 96-week noncomparative study in HIV-infected patients with severe facial lipoatrophy, 41% of patients treated with intradermal poly-L-lactic acid injections had a total cutaneous thickness of >10mm at the nasogenian fold at week 24. Poly-L-lactic acid was injected into multiple sites of each cheek at baseline and at weeks 2, 4, and 6.
Significant (p < 0.001) increases from baseline in total cutaneous thickness were reported at all evaluation timepoints up to 96 weeks after the start of treatment.
In a randomized, nonblind study, significant (p < 0.001) increases from baseline in dermal thickness were observed at week 24 in HIV-infected patients with facial lipoatrophy who received immediate or deferred (by 12 weeks) treatment with poly-L-lactic acid, administered by injection into multiple intradermal sites every 2 weeks (three injection sessions in total)
Improvements in depression and anxiety scores, patient visual analog scale assessments, and photographic assessments were also reported in patients treated with poly-L-lactic acid in the immediate versus deferred treatment trial.
Poly-L-lactic acid was generally well tolerated. No serious adverse events were reported.
In August 2004, the US Food and Drug Administration approved a poly-L-lactic acid (PLLA)-based injectable medical device for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. As a result, the properties of the PLLA microparticles have received considerable interest from the medical community. Polylactides have a long-standing history of safe use in medical applications, such as pins, plates, screws, intra-bone and soft-tissue implants, and as vectors for sustained release of bioactive compounds. The L-isomer of polylactic acid is a biodegradable, biocompatible, biologically inert, synthetic polymer. Putatively, PLLA microparticles initiate neocollagenesis as a result of a normal foreign-body reaction to their presence. The build-up of collagen over time creates volume at the site of injection, while the PLLA microparticles are metabolized to carbon dioxide and water and expelled through the respiratory system.
Acne scars may negatively impact quality of life. The purpose of this study was to collect preliminary data on the efficacy and safety of injectable poly-L-lactic acid (PLLA, Sculptra, Dermik Laboratories) for the treatment of acne scars.
Twenty subjects aged 42.4+/-10.7 years (10 men, 10 women) with facial scars resulting from moderate to severe acne or varicella participated in this single-center, open-label prospective study. The primary end point was the resolution of the acne or varicella scars. Secondary end points were the physician and subject assessments of scar improvement. PLLA reconstituted with 5 mL of sterile water was injected serially at or near the sites of the acne scars without topical anesthesia.
Investigator-assessed reductions in acne scar size and severity were significant (p<.0001) during the course of seven treatments. Subject-rated reduction in scar severity was also significant (p=.0078). Subject satisfaction with treatment trended toward an increase with each treatment session and approached significance (p=.0899). Adverse events were limited to depression (n=1) not related to the treatment.
Injectable PLLA as used in this investigation appears to correct the types of acne scars treated in this study without serious adverse effects.