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1.
J Cosmet Dermatol ; 22(7): 1969-1972, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36760160

ABSTRACT

INTRODUCTION: Aesthetic medicine is characterized by the efficacy and safety of treatments. Although sometimes adverse events could be occurred, in this case vascular occlusion is the most serious of them. The tissue is deprived of oxygen and there is a possibility of necrosis, so it is necessary to remove the tissue filler and promote oxygenation. OBJECTIVE: We propose the hyperbaric oxygenation treatment to oxygenate the tissue after vascular occlusion generated by a tissue filler such as Hyaluronic Acid. RESULTS: We show how hyperbaric oxygenation treatment is an adjuvant therapy after vascular occlusion, improving tissue regeneration and prevent or limit scars or sequelae. CONCLUSION: Hyperbaric oxygenation treatment is a safe and effective method to treat vascular accident, improving tissue oxygenation in early cases and improving tissue regeneration in cases with necrosis.


Subject(s)
Dermal Fillers , Hyperbaric Oxygenation , Humans , Hyperbaric Oxygenation/adverse effects , Wound Healing , Hyaluronic Acid/adverse effects , Cicatrix/etiology , Necrosis/chemically induced , Dermal Fillers/adverse effects
2.
BMJ Case Rep ; 15(7)2022 Jul 07.
Article in English | MEDLINE | ID: mdl-35798493

ABSTRACT

Vascular compromise and resulting ischaemic injury are known rare complications of cosmetic filler injections. Most hyaluronic acid vascular compromises present early and can be treated effectively by hyaluronidase. Here we present a case of ischaemic wound and mucosal necrosis after cosmetic facial hyaluronic acid injection that appeared within hours of injection but was not diagnosed and treated for 5 days. At day 5, the patient was treated with hyaluronidase injection immediately followed by 14 sessions of daily hyperbaric oxygen therapy (HBOT). Despite the delayed treatment, the patient had essentially complete recovery and the hyperbaric therapy was overall well-tolerated. Our case report suggests that hyaluronidase injection with concurrent daily HBOT sessions may be effective to allow recovery from late-presenting filler ischaemic complication. Furthermore, given the safety profile of HBOT, we suggest a more deliberate approach to this modality as a therapeutic adjunct by cosmetic practitioners when similar complications arise.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Hyperbaric Oxygenation , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Humans , Hyaluronic Acid/adverse effects , Hyaluronoglucosaminidase , Injections, Subcutaneous , Ischemia/chemically induced , Ischemia/therapy
3.
J Drugs Dermatol ; 21(5): 481-487, 2022 May 01.
Article in English | MEDLINE | ID: mdl-35533030

ABSTRACT

BACKGROUND: Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks. METHODS: A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting. RESULTS: Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity. CONCLUSION: CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Calcium , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Durapatite/adverse effects , Humans , Hyaluronic Acid , Lidocaine/adverse effects , Nasolabial Fold , Treatment Outcome
5.
J Plast Reconstr Aesthet Surg ; 74(7): 1610-1614, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34024740

ABSTRACT

Hyaluronidase is a family of enzymes that degrade hyaluronic acid (HA). It is found to increase vascular permeability and temporarily disrupt the extracellular matrix, promoting diffusion of substances through tissues. Alongside its applications in ophthalmology, obstetrics and gynaecology, musculoskeletal medicine, radiology and drug and fluid administration, hyaluronidase has a number of roles in the field of plastic surgery. The popularity of HA fillers in recent years has led to an increase in the usage of hyaluronidase in the treatment of filler-related complications. The purpose of this article is to review the current and future uses of hyaluronidase within the field of plastic surgery. Hyaluronidase is used as an adjunct to local anaesthetics in skin infiltration, skin graft harvesting, tumescent analgesia, managing complications of dermal fillers, treatment of extravasation injury, prevention and management of oedema, treatment of ganglion and management of scars. However, it has some limitations. Hyaluronidase is known to interact with a number of common medications. Several case reports also highlight the risk of allergic reaction to the substance. Although rare and usually mild, hyaluronidase has the potential to cause anaphylaxis. Other adverse effects include bruising and swelling. Overall, hyaluronidase appears to be a very safe, cheap and effective medication for a variety of uses in the field of plastic surgery and beyond.


Subject(s)
Adjuvants, Anesthesia , Anesthesia, Local/methods , Cicatrix/drug therapy , Dermal Fillers/adverse effects , Hyaluronic Acid/adverse effects , Hyaluronoglucosaminidase/therapeutic use , Plastic Surgery Procedures , Dermal Fillers/metabolism , Drug Hypersensitivity/etiology , Humans , Hyaluronic Acid/metabolism , Hyaluronoglucosaminidase/adverse effects , Hyaluronoglucosaminidase/metabolism
6.
J Am Pharm Assoc (2003) ; 61(4): e324-e331, 2021.
Article in English | MEDLINE | ID: mdl-33810997

ABSTRACT

BACKGROUND: This report presents the case of a patient who developed a nonthrombotic embolus attributed to a polyalkylimide dermal filler, and it also charts pharmacotherapeutic strategies for polyalkylimide complications reported in the literature. CASE SUMMARY: A 31-year-old female presented to a community teaching hospital with dyspnea, hemoptysis, and fever. A thorough history revealed that the patient received intragluteal injections of a polyalkylimide dermal filler (Bio-Alcamid) 4 days before hospitalization, although it was initially and incorrectly diagnosed as silicone embolism syndrome. High-dose intravenous steroids and antibiotics were ineffective, and the patient was transferred to a higher level of care for surgical management. Therein, the patient developed additional complications, including multiple thromboembolic events and the need for long-term enteral nutrition. After a 63-day stay in the intensive care unit and a 13-day stay in an inpatient postacute facility, the patient's postdischarge care transitions included 3 subsequent emergency department visits related to enteral feeding tube malfunction. PRACTICE IMPLICATIONS: Polyalkylimide is a hydrogel polymer derived from acrylic acid that is used as a dermal filler. Postinjection complications include dermal filler migration and abscess formation. Surgical resection of the filler and prophylactic antibiotics have, anecdotally, been used with success. Comparatively, silicone dermal filler complications may be treated with high-dose intravenous corticosteroids. Although silicone and polyalkylimide are both classified as permanent dermal fillers, the management of their complications differs, especially with regard to medications. This case underscores the necessity for clinicians to accurately identify the type of dermal filler used in order to recommend effective medication management to treat complications. Unlike silicone dermal filler treatment, corticosteroids may actually exacerbate polyalkylimide dermal filler complications. Beta-lactam antibiotics for at least 14 days may be reasonable to treat the cutaneous infectious complications arising from polyalkylimide dermal filler use.


Subject(s)
Dermal Fillers , Pulmonary Embolism/chemically induced , Adult , Aftercare , Dermal Fillers/adverse effects , Female , Humans , Medication Therapy Management , Patient Discharge , Polymers
10.
J Cosmet Dermatol ; 19(6): 1307-1310, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32281282

ABSTRACT

Hyaluronic acid filler injection is commonly used for aesthetic purposes. However, many clinicians neglect the possibility of developing vascular occlusion and its devastating sequelae. Besides visual loss after iatrogenic ophthalmic artery occlusion, ophthalmoplegia without blindness is rare but may occur. Here, we report a 23-year-old woman with ptosis, lateral deviation of the right eye, and skin necrosis after hyaluronic acid filler injection. After hyaluronidase injection and steroid pulse therapy, ptosis and eye movement were completely restored. Skin necrosis was treated with a human epithelial growth factor ointment, followed by Nd:YAG laser. Complete healing with minimal scar was achieved.


Subject(s)
Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Hyaluronic Acid/adverse effects , Ophthalmoplegia/etiology , Skin/pathology , Dermal Fillers/administration & dosage , Diffusion Magnetic Resonance Imaging , Face , Female , Humans , Hyaluronic Acid/administration & dosage , Lasers, Solid-State , Low-Level Light Therapy , Necrosis/etiology , Necrosis/therapy , Oculomotor Muscles/diagnostic imaging , Oculomotor Muscles/drug effects , Ophthalmoplegia/therapy , Treatment Outcome , Young Adult
11.
J Cosmet Dermatol ; 19(11): 2845-2858, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32185876

ABSTRACT

BACKGROUND: Inadvertent intra-arterial injection of dermal fillers including calcium hydroxylapatite (CaHA) can result in serious adverse events including soft tissue necrosis, permanent scarring, visual impairment, and blindness. When intra-arterial injection occurs, immediate action is required for optimal outcomes, but the infrequency of this event means that many physicians may never have experienced this scenario. The aim of this document is to provide evidence-based and expert opinion recommendations for the recognition and management of vascular compromise following inadvertent injection of CaHA. METHODS: An international group of experts with experience in injection of CaHA and management of vascular complications was convened to develop a consensus on the optimal management of vascular compromise following intra-arterial CaHA injection. The consensus members were asked to provide preventative advice for the avoidance of intravascular injection and to produce a treatment protocol for acute and delayed presentation. To ensure all relevant treatment options were included, the recommendations were supplemented with a PubMed search of the literature. RESULTS: For prevention of intra-arterial CaHA injection, consensus members outlined the importance of a thorough knowledge of facial vascular anatomy and patient history, as well as highlighting potential risk zones and optimal injection techniques. Individual sections document how to recognize the symptoms of vascular occlusion leading to vision loss and tissue necrosis as well as detailed treatment protocols for the management of these events. For impending tissue necrosis, recommendations are provided for early and delayed presentations with treatment protocols for acute and follow-up treatment. A separate section details the treatment options for open and closed wounds. CONCLUSIONS: All physicians should be prepared for the eventuality of intra-arterial injection of a dermal filler, despite its rarity. These consensus recommendations combine advice from aesthetic experts with the latest reports from the published literature to provide an up-to-date office-based protocol for the prevention and treatment of complications arising from intra-arterial CaHA injection.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Calcium , Consensus , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Durapatite/adverse effects , Humans
12.
J Cosmet Dermatol ; 19(3): 596-604, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31347766

ABSTRACT

BACKGROUND: In this study, a physical properties test and preclinical evaluation were performed on two polycaprolactone (PCL)-based dermal filler formulas. OBJECTIVE: This study was performed to compare the rheological characteristics, preclinical efficacy, and safety of a new PCL filler, SF-01, with a licensed PCL filler. METHODS: First, the viscoelasticity of the PCL filler was evaluated. Next, hairless mice were injected with fillers and evaluated for efficacy with a folliscope and PRIMOSLITE . Histological evaluation was conducted for 6 months to evaluate safety. RESULTS: In this evaluation, SF-01 was superior to a licensed PCL filler in initial volume increase rate and in vivo durability, and the migration of the injected filler was not confirmed. The elasticity (G*, G') and viscosity (G'') are also expected to be lower than those of a licensed PCL filler, thereby resulting in less foreign body sensation in the living body. CONCLUSION: SF-01 (porous PCL microsphere-based dermal filler) has been confirmed to be superior in durability and shape retention compared to the licensed PCL filler (nonporous PCL microsphere-based dermal filler), and the in vivo safety is equivalent.


Subject(s)
Cosmetic Techniques/adverse effects , Dermal Fillers/administration & dosage , Microspheres , Polyesters/administration & dosage , Skin/drug effects , Animals , Collagen/analysis , Collagen/metabolism , Dermal Fillers/adverse effects , Dermal Fillers/chemistry , Drug Evaluation, Preclinical , Elasticity , Injections, Subcutaneous , Mice , Mice, Hairless , Models, Animal , Polyesters/adverse effects , Polyesters/chemistry , Porosity , Rheology , Skin/chemistry , Skin/metabolism , Viscosity
14.
Aesthetic Plast Surg ; 43(4): 1061-1070, 2019 08.
Article in English | MEDLINE | ID: mdl-31073742

ABSTRACT

BACKGROUND: Facial aging is a process that involves many different changes. Therefore, in many patients, it may be necessary to perform a combined treatment. Botulinum toxin A and dermal fillers are the two most popular nonsurgical cosmetic procedures performed globally to treat age-associated changes. However, there are not many studies reporting the concomitant use of dermal fillers and laser technology for facial rejuvenation. This review aims to assess the concomitant use of dermal hyaluronic acid (HA) fillers and laser technology for facial rejuvenation. METHODS: The present updated consensus recommendations are based on the experience and opinions of the authors and on a literature search. RESULTS: If a combined procedure (HA and light treatments) is to be performed, on the same day, the panel recommends starting always with the light treatments, avoiding skin manipulations after having injected HA. To customize the therapeutic management, it is crucial to establish a precise diagnosis of the photodamage and loss of volumes suffered by the patients. CONCLUSIONS: The currently available scientific evidence about the combined use of HA fillers and laser-radiofrequency-intense pulsed light (laser/RF/IPL) is limited and encompasses mainly small and nonrandomized studies. Nevertheless, most of these studies found that, on average, the concomitant use (same day) of laser and HA fillers for facial rejuvenation represents an effective and safe strategy which improves clinical results and patient's satisfaction. Future well-designed clinical studies are needed regarding the effectiveness and safety of combination filler/laser treatments. LEVEL OF EVIDENCE IV: 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 .


Subject(s)
Dermal Fillers/administration & dosage , Hyaluronic Acid/administration & dosage , Low-Level Light Therapy/methods , Skin Aging/drug effects , Skin Aging/radiation effects , Aged , Combined Modality Therapy , Dermal Fillers/adverse effects , Esthetics , Face , Female , Humans , Injections, Subcutaneous , Middle Aged , Patient Satisfaction , Rejuvenation , Risk Assessment , Treatment Outcome
15.
J Cosmet Dermatol ; 18(3): 747-754, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31074085

ABSTRACT

INTRODUCTION: The purpose of this manuscript is to investigate the treatment of skin soft tissue embolization or vascular occlusion after the injection of hyaluronic acid (HA) for Injection Rhinoplasty (IR) in Asians with a special interest in the time occurrence of the occlusion. METHODS: A total of 35 cases were evaluated after receiving HA injections for IR who presented with a vascular occlusive event. They were divided into three stages based on the time to embolization. Immediate, ≤5 hours; early, ≤3 days; and late, >3 days. There were two cases of immediate, 28 deemed early, and five late. Methods to prevent tissue necrosis are reviewed in the manuscript based on these stages. RESULTS: Skin color gradually recovered to normal after 11 treatments in 11 patients with mild embolization. No ischemic aggravation or skin necrosis was observed in 19 patients with moderate embolization; red scarring was seen in two and hypertrophic scar with uneven skin color in one patient. The five patients in the severe category had longer healing, more red scars, and more hypertrophic scarring. CONCLUSION: The treatment of skin soft tissue embolization or vascular occlusion after HA IR in Asians can be effected by identifying the stage and degree of embolization and treating appropriately with the outlines presented in this manuscript.


Subject(s)
Cicatrix, Hypertrophic/therapy , Dermal Fillers/adverse effects , Embolism/therapy , Hyaluronic Acid/adverse effects , Rhinoplasty/adverse effects , Adult , Anti-Inflammatory Agents/administration & dosage , Asian People , Cicatrix, Hypertrophic/etiology , Dermal Fillers/administration & dosage , Embolism/etiology , Female , Humans , Hyaluronic Acid/administration & dosage , Hyaluronoglucosaminidase/administration & dosage , Injections, Subcutaneous/adverse effects , Lasers, Dye/therapeutic use , Low-Level Light Therapy/instrumentation , Low-Level Light Therapy/methods , Male , Massage , Necrosis/etiology , Necrosis/therapy , Rhinoplasty/methods , Skin/pathology , Time Factors , Vasodilator Agents/administration & dosage , Young Adult
16.
Undersea Hyperb Med ; 46(2): 207-210, 2019.
Article in English | MEDLINE | ID: mdl-31051067

ABSTRACT

Dermal injection of fillers is a popular and relatively safe aesthetic procedure. Severe complications are rare, but they do occur. One of the most threatening complications after dermal filler injection is skin necrosis due to vascular occlusion. Different treatment options are available, including the use of hyperbaric oxygen (HBO2) therapy. A 46-year-old female received facial dermal filler injections with calcium hydroxylapatite at an aesthetic clinic. A few days after injection she developed a burning pain, numbness of the skin and white discoloration in the injected area. Two days after injection treatment was started with hyaluronidase and warm compresses. In addition, the patient received prednisolone, sildenafil and nifedipine. After the start of these treatments, the pain, numbness and discoloration of the skin persisted. Because of dermal ischemia and to improve healing she was referred for HBO2. Treatment consisted of 10 sessions of 100% oxygen for 90 minutes in a multiplace chamber at 2.5 atmospheres absolute pressure. During HBO2 the discoloration resolved, pain and numbness disappeared, and the tissue healed completely. After a six-month follow-up she had an excellent cosmetic outcome. Given the pathophysiologic mechanisms of vascular complications after dermal filler injection, HBO2 should be considered when treating these complications.


Subject(s)
Biocompatible Materials/adverse effects , Dermal Fillers/adverse effects , Face/blood supply , Hyperbaric Oxygenation , Ischemia/therapy , Skin/blood supply , Female , Humans , Ischemia/etiology , Middle Aged , Photography
17.
J Cosmet Dermatol ; 18(4): 1002-1008, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30985064

ABSTRACT

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.


Subject(s)
Dermal Fillers/administration & dosage , Rejuvenation , Skin Aging/drug effects , Skin/drug effects , Animals , Collagen/metabolism , Dermal Fillers/adverse effects , Drug Evaluation, Preclinical , Female , Injections, Subcutaneous , Materials Testing , Mice , Mice, Hairless , Microspheres , Models, Animal , Polydioxanone/administration & dosage , Polydioxanone/adverse effects , Polyesters/administration & dosage , Polyesters/adverse effects , Random Allocation , Skin/metabolism , Skin/radiation effects , Skin Aging/radiation effects , Ultraviolet Rays/adverse effects
18.
J Drugs Dermatol ; 17(11): 1184 -1185, 2018 11 01.
Article in English | MEDLINE | ID: mdl-30500137

ABSTRACT

Bruising after dermal filler and neuromodulator injections is a common side effect and can have durations of 1 to 2 weeks. While it ultimately resolves, faster resolution can produce better outcomes for patients and also make patients more likely to return for future treatments. We report the successful reduction in bruising following injections of fillers with an intense pulsed light source. We also documented the onset of action of bruising resolution with serial photographs. Resolution started within the first hour of treatment and continued rapidly over 48 hours. This is the first-time reported study of resolution of bruising from injectables with intense pulsed light. Patient satisfaction is improved when such adverse events are minimized.


Subject(s)
Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Ecchymosis/therapy , Intense Pulsed Light Therapy/methods , Rejuvenation , Dermal Fillers/administration & dosage , Ecchymosis/diagnostic imaging , Ecchymosis/etiology , Humans , Injections, Subcutaneous/adverse effects , Intense Pulsed Light Therapy/adverse effects , Intense Pulsed Light Therapy/instrumentation , Lasers, Dye/adverse effects , Low-Level Light Therapy/adverse effects , Low-Level Light Therapy/instrumentation , Low-Level Light Therapy/methods , Patient Satisfaction , Photography , Skin Aging , Treatment Outcome
19.
Dermatol Ther ; 31(6): e12721, 2018 11.
Article in English | MEDLINE | ID: mdl-30394647

ABSTRACT

Fillers have become popular worldwide as the demand for enhancements in rejuvenating effects and esthetic improvements is continually increasing. With broader applications and the increasing number of cosmetic procedures using fillers, more filler-related complications are being reported. These filler-related complications range from mild bruising to severe vascular complications. Because of the severe and irreversible outcomes of vascular complications, treatment protocols for such complications are being investigated and updated actively. However, not much attention is paid to mild bruises that develop after filler injections. Simple observation is the treatment of choice for bruises in current filler complication protocols. In the present study, the possible effect of a pulsed-dye laser (PDL) on bruises is reported, with a case report of a female patient who received PDL treatment for a bruise that developed after a filler injection.


Subject(s)
Contusions/radiotherapy , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Hyaluronic Acid/adverse effects , Lasers, Dye/therapeutic use , Low-Level Light Therapy/instrumentation , Adult , Contusions/diagnosis , Contusions/etiology , Dermal Fillers/administration & dosage , Female , Humans , Hyaluronic Acid/administration & dosage , Injections, Intradermal , Treatment Outcome
20.
J Drugs Dermatol ; 17(9): 999-1004, 2018 Sep 01.
Article in English | MEDLINE | ID: mdl-30235388

ABSTRACT

INTRODUCTION: Lip plumpers are topical agents that offer immediate, but temporary, volumization of the lips. While these products are becoming increasingly popular and are available at multiple retailers, there is a lack of clinical studies to evaluate the efficacy, longevity, and safety of the lip plumping products. METHODS: This is a prospective, single center, clinical trial to evaluate the duration, efficacy, and safety of a lip plumping agent in two clinical visits. Lip volume and adverse event were assessed by two clinicians at various time points: 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours. RESULTS: Twenty-two subjects were enrolled in the study, and eighteen completed the study. Investigator assessments of global improvement 15 minutes after application of the lip plumping product demonstrated improvement in lip fullness in 100% of the subjects (18/18), and 1 hour post-application 67% (12/18) showed an improvement in lip fullness that was statistically significant compared to the 2-hour assessment (P less than 0.05). Subject evaluations noted improvement in lip fullness 15 minutes post-application in 94.4% (17/18) of subjects, and 1 hour post-application, 89% (16/18) of the subjects who completed the trial noted some improvement in the volume of their lips that was statistically significant compared to the 2-hour post-application time point (P less than 0.0001). Subjects noted that they did experience a tingling and heat sensation, but a majority noted that that this sensation lasted less than 15 minutes. DISCUSSION: Our study demonstrated that the lip plumping product increased lip volume in almost all patients 15 minutes post-application and showed a continued improvement in lip fullness per investigator assessments 1 hour after application. Adverse events of a tingling or heat sensation were expected and observed as the topical product contained capsaicin, cinnamon, and menthol, all of which can induce this sensation by the release of substance P. J Drugs Dermatol. 2018;17(9):999-1004.


Subject(s)
Dermal Fillers/therapeutic use , Lip , Skin Aging , Viscoelastic Substances/therapeutic use , Administration, Cutaneous , Adult , Capsaicin/chemistry , Cinnamomum zeylanicum/chemistry , Cosmetic Techniques , Dermal Fillers/administration & dosage , Dermal Fillers/adverse effects , Drug Compounding , Female , Humans , Male , Menthol/chemistry , Middle Aged , Prospective Studies , Treatment Outcome , Viscoelastic Substances/administration & dosage , Viscoelastic Substances/adverse effects , Young Adult
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