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BACKGROUND: Regenerative aesthetics has garnered significant attention. In this toolkit, exosomes are small extracellular vesicles derived from various sources such as platelets. OBJECTIVE: To characterize the cosmetic effect and tolerability of topical human platelet-derived extract (HPE), Intense Serum (Rion Aesthetics, Inc., Rochester, MN), on facial skin rejuvenation after 12 weeks of twice daily use without any confounding aesthetic procedures. MATERIALS AND METHODS: This prospective, single-arm, non-randomized, evaluator-blinded clinical study evaluated subjects at baseline and 12 weeks using participant questionnaires and photo-documentation with Canfield VISIA-CR 3D PRIMOS. The histological evaluation included Masson's Trichrome for collagen and Verhoeff-Van Gieson staining for elastin. Electron microscopy characterized collagen bundle thickness. RESULTS: Fifty-six participants (mean age: 54 years old) were enrolled. Following topical HPE use, 87.3% of subjects reported improvement in facial skin aging including sustained pigment reduction and improvement in luminosity and color evenness at 12 weeks (P≤0.001). Histology revealed a significant increase in collagen fibril thickness at 12 weeks (P≤0.0001). No serious adverse effects. CONCLUSION: This study demonstrates improvement in facial skin health after topical HPE use, supported by collagen and elastin formation in the dermis. The product is well-tolerated, and participants were satisfied with the overall cosmetic outcome. J Drugs Dermatol. 2024;23(9):735-740. doi:10.36849/JDD.8162.
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Plaquetas , Colágeno , Elastina , Face , Rejuvenescimento , Envelhecimento da Pele , Humanos , Pessoa de Meia-Idade , Envelhecimento da Pele/efeitos dos fármacos , Feminino , Estudos Prospectivos , Colágeno/metabolismo , Masculino , Plaquetas/efeitos dos fármacos , Adulto , Idoso , Administração Cutânea , Resultado do Tratamento , Técnicas Cosméticas/efeitos adversos , Pele/efeitos dos fármacos , Pele/patologia , Método Simples-CegoRESUMO
INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12. CONCLUSIONS: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04214639 and NCT04214652.
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BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Adulto , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Testa , Humanos , Resultado do TratamentoRESUMO
Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.Erratum published for this article here.
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Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15 To receive a CME certificate of participation, you should: â¢Read the entire publication, including the CME information. â¢Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.
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Toxinas Botulínicas Tipo A/administração & dosagem , Consenso , Técnicas Cosméticas/normas , Face/anatomia & histologia , Toxinas Botulínicas Tipo A/efeitos adversos , Congressos como Assunto , Técnicas Cosméticas/efeitos adversos , Estética , Músculos Faciais/efeitos dos fármacos , Músculos Faciais/inervação , Feminino , Humanos , Injeções Intramusculares/efeitos adversos , Injeções Intramusculares/métodos , Injeções Intramusculares/normas , Masculino , Planejamento de Assistência ao Paciente/normas , Satisfação do Paciente , Rejuvenescimento , Fatores Sexuais , Envelhecimento da Pele , Sociedades Médicas/normas , Cirurgia Plástica/normas , Resultado do Tratamento , Estados UnidosRESUMO
Correction to the supplement, Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update (J Drugs Dermatol. 2020; 19:4 Supp 1).
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Alopecia , Finasterida , Inibidores de 5-alfa Redutase , Administração Oral , Feminino , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need. OBJECTIVE: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK). METHODS: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later. RESULTS: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106. LIMITATIONS: The optimal number of treatment sessions was not evaluated. CONCLUSION: Application of HP40 was well tolerated and effective in the removal of SKs.
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Peróxido de Hidrogênio/uso terapêutico , Ceratose Seborreica/diagnóstico , Ceratose Seborreica/tratamento farmacológico , Administração Tópica , Adulto , Idoso , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Medição de Risco , Resultado do Tratamento , Estados UnidosRESUMO
Skin aging is continuously influenced by various internal and external factors such as the biologic progression of cells, ultraviolet (UV) radiation, tobacco, nutritional deficiencies, and hormonal imbalances that lead to the degradation of skin cells. Through the degradation of skin cells, free radicals and inflammation weaken repair mechanisms and result in collagen and elastic fiber breakdown. The appearance of aging skin is highlighted by skin roughness, wrinkling, pigmentation change, telangiectasias, loss of elasticity, and decreased firmness, all of which are accelerated by these internal and external factors. Throughout the years, nutraceuticals have been studied to delay and fight against these internal and external factors, many of which are found in foods and byproducts consumed naturally. The aim of this review is to aid dermatologists in understanding the mechanism of action of popular nutraceuticals and their possible efficacy in antiaging and skin health.
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The importance of training in minimally invasive cosmetic procedures is essential to insure safe outcomes for patients. Board certification in the appropriate specialty is one way to improve aesthetic outcomes. Meetings that consider appropriate residency training for admission can help achieve this goal.
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*Proceedings from a recent cosmetic dermatology conference, Cosmetic Bootcamp, Aspen, CO.
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Toxinas Botulínicas Tipo A/administração & dosagem , Congressos como Assunto , Técnicas Cosméticas , Uso Off-Label , Envelhecimento da Pele/efeitos dos fármacos , Colorado , Congressos como Assunto/tendências , Técnicas Cosméticas/tendências , Humanos , Envelhecimento da Pele/patologiaRESUMO
Cosmetic patients are looking for a more youthful appearance without spending a lot of money, feeling any pain, or experiencing any postprocedure downtime. New cosmeceutical therapies can be used adjuvant to chemical peels, lasers, and injectables, making antiaging regimens less painful and requiring less postprocedural healing time. Adjunctive agents can be used to enhance chemical peels and decrease postinflammatory hyperpigmentation (PIH). Topical retinoids used prior to ablative laser treatments can aid in faster postprocedure healing and reepithelialization. Cosmeceuticals that contain both antioxidants and anti-inflammatories can help reduce postprocedure inflammation. Acetyl hexapeptide-3 is an effective topical agent for decreasing wrinkles and can be used as an adjunct to intramuscular botulinum neurotoxin, which may reduce the number of injections needed. Topical hyaluronic acid also would help patients who are averse to needles or are just starting to get wrinkles and are looking for noninvasive therapy. This article reviews combinations of cosmeceuticals with cosmetic procedures that dermatologists may want to consider discussing with their cosmetic patients.
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Fármacos Dermatológicos/administração & dosagem , Terapia com Luz de Baixa Intensidade , Envelhecimento da Pele , Terapia Combinada , Técnicas Cosméticas , Humanos , RejuvenescimentoRESUMO
Cosmeceuticals are topically applied products that are more than merely cosmetic, yet are not true drugs that have undergone rigorous placebo controlled studies for safety and efficacy. There are many review articles that outline the theoretical biologic and clinical actions of these cosmeceuticals and their various ingredients. This article reviews how to incorporate various cosmeceuticals into the treatment regime of patients, depending on the diagnosis and therapies chosen. The practical application of when, why, and on whom to use different products will enable dermatologists to improve the methodology of product selection and, ultimately, improve patient's clinical results.
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OBJECTIVES: To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA). MATERIALS AND METHODS: Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months. RESULTS: Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events. CONCLUSION: This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.
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Anestésicos Locais/uso terapêutico , Materiais Biocompatíveis , Técnicas Cosméticas , Ácido Hialurônico , Lidocaína/uso terapêutico , Adulto , Idoso , Anestésicos Locais/administração & dosagem , Anestésicos Locais/química , Materiais Biocompatíveis/administração & dosagem , Materiais Biocompatíveis/efeitos adversos , Materiais Biocompatíveis/química , Contusões/prevenção & controle , Método Duplo-Cego , Eritema/prevenção & controle , Feminino , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Ácido Hialurônico/química , Injeções , Lidocaína/administração & dosagem , Lidocaína/química , Masculino , Pessoa de Meia-Idade , Dor/induzido quimicamente , Dor/prevenção & controle , Estudos Prospectivos , Resultado do TratamentoRESUMO
The types and number of dermal fillers have evolved, allowing clinicians to select the most appropriate agent for each specific use. Filler properties differ both between and among classes, so clinicians must have a thorough understanding of these properties and the best techniques to use to provide the most satisfactory outcomes. This article reviews and highlights the key properties of different types of fillers, technical aspects of their use, safety considerations and the importance of patient factors in treatment selection. Making the right treatment choices must involve all of these issues to optimize aesthetic outcomes and patient satisfaction. The authors illustrate how to make the best choices through a series of case examples using a variety of filler types. Although most fillers can provide acceptable outcomes when used appropriately, the hyaluronic acids have become the most frequently used products because of their physicochemical properties and clinical benefits.
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Materiais Biocompatíveis/uso terapêutico , Técnicas Cosméticas , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Materiais Biocompatíveis/administração & dosagem , Materiais Biocompatíveis/efeitos adversos , Colágeno/administração & dosagem , Colágeno/efeitos adversos , Colágeno/uso terapêutico , Técnicas Cosméticas/efeitos adversos , Feminino , Humanos , Ácido Hialurônico/administração & dosagem , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do TratamentoRESUMO
Cosmeceuticals are topically applied products that are more than merely cosmetic, yet are not true drugs that have undergone rigorous placebo controlled studies for safety and efficacy. There are many review articles that outline the theoretical biologic and clinical actions of these cosmeceuticals and their various ingredients. This article reviews how to incorporate various cosmeceuticals into the treatment regime of patients, depending on the diagnosis and therapies chosen. The practical application of when, why, and on whom to use different products will enable dermatologists to improve the methodology of product selection and, ultimately, improve patient's clinical results.