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1.
Aesthet Surg J ; 2024 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-38985546

RESUMO

BACKGROUND: A well-defined jawline improves overall facial aesthetics, thus motivating patients to seek jawline augmentation. OBJECTIVES: This study will evaluate the safety and effectiveness of the hyaluronic acid injectable gel VYC-25L for restoring jawline definition. METHODS: A US multicenter, evaluator-blinded study randomized adults with grade 2 (moderate) or 3 (severe) Allergan Loss of Jawline Definition Scale (ALJDS) scores. Participants were randomized to VYC-25L treatment group or control group at study onset, with 12 months follow-up. The control group had the option to receive treatment after 6 months (primary endpoint completion). Effectiveness measures included month 6 ALJDS responders rate (proportion of participants with ≥1-grade improvement from baseline on both sides), FACE-Q Satisfaction With Lower Face and Jawline scores, and Global Aesthetic Improvement Scale (GAIS) responders (improved/much improved) as assessed by the investigator and participants. Injection site responses (ISRs) and adverse events (AEs) were monitored. RESULTS: At month 6, ALJDS responder rates were 69.0% versus 38.0% in the VYC-25L treatment (n = 157) and control (n = 49) groups, respectively (p = .0001). In the VYC-25L treatment group, FACE-Q scores improved by a mean of 45.9 points versus baseline at month 6 (p < .0001). Furthermore, 88.4% and 89.0% of participants in the VYC-25L treatment group were GAIS responders on month 6 by participant- and investigator-assessment, respectively. Most ISRs were mild or moderate and resolved within 2 weeks. Most treatment-related AEs were mild and resolved within a week. CONCLUSIONS: VYC-25L safely and effectively restores jawline definition through 1 year.

2.
Aesthet Surg J ; 42(11): 1318-1327, 2022 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-35704394

RESUMO

BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.


Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Método Duplo-Cego , Feminino , Testa , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Satisfação Pessoal , Resultado do Tratamento
3.
Dermatol Surg ; 45(12): 1558-1566, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-30829754

RESUMO

BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment. PATIENTS AND METHODS: In this open-label, nonrandomized, multicenter pilot study investigating the use of polymethylmethacrylate for full-face atrophic acne scar correction, 42 adult subjects with a mean age of 43 years were treated and assessed for safety and effectiveness at Months 4 and 7. There were no hypersensitivity reactions to pretreatment skin testing or during scar treatments. RESULTS: At 4 and 7 months after initial treatment, 92% and 95% of subjects, respectively, were responders with ≥1-point improvement on the 5-point Acne Scar Assessment Scale. Subjects reported very high levels of improvement on the Global Aesthetic Improvement Scale (GAIS), with 95% of subjects reporting "improved or better" at 4 months and 90% at 7 months. The outcome of the physician GAIS was also high with 92% of patients classified as "improved or better" at 4 months and 97% at 7 months. There were only 2 device-related adverse events, both mild events related to Bellafill skin test (bruising, ecchymosis). There were no serious adverse events in response to the treatment product in this short-term follow-up study. CONCLUSION: Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.


Assuntos
Acne Vulgar/complicações , Cicatriz/terapia , Colágeno/administração & dosagem , Preenchedores Dérmicos/administração & dosagem , Polimetil Metacrilato/administração & dosagem , Adulto , Atrofia/diagnóstico , Atrofia/etiologia , Atrofia/terapia , Cicatriz/diagnóstico , Cicatriz/etiologia , Colágeno/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Equimose/diagnóstico , Equimose/etiologia , Face , Feminino , Seguimentos , Humanos , Injeções Intralesionais , Masculino , Polimetil Metacrilato/efeitos adversos , Estudo de Prova de Conceito , Índice de Gravidade de Doença , Testes Cutâneos/efeitos adversos , Resultado do Tratamento , Adulto Jovem
4.
Dermatol Surg ; 44(11): 1437-1448, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30096106

RESUMO

BACKGROUND: Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies. OBJECTIVE: Evaluate safety and efficacy of onabotulinumtoxinA for treatment of forehead lines (FHL) distributed between the frontalis (20 U) and glabellar complex (20 U), with or without simultaneous lateral canthal areas (crow's feet lines [CFL], 24 U) treatment. METHODS: Subjects with moderate to severe FHL were randomized (2:2:1) to onabotulinumtoxinA 40 U, onabotulinumtoxinA 64 U, or placebo. After 180 days, subjects could receive up to 2 additional open-label onabotulinumtoxinA 64 U treatments. RESULTS: The intent-to-treat (ITT) population comprised 787 subjects, and the modified ITT (mITT) population (subjects with psychological impact) comprised 568. After 30 days, onabotulinumtoxinA 40 U and 64 U significantly improved investigator- and subject-assessed FHL severity by at least 2 Facial Wrinkle Scale (FWS) grades in 45.6% and 53.0% of ITT subjects, respectively, versus 0.6% receiving placebo (both, p < .0001). Significantly more mITT subjects receiving onabotulinumtoxinA achieved investigator- and subject-assessed FWS ratings of none/mild versus placebo (p < .0001). OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Técnicas Cosméticas , Face , Fármacos Neuromusculares/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Toxinas Botulínicas Tipo A/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/administração & dosagem , Resultado do Tratamento
5.
Aesthet Surg J ; 36(5): 591-7, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26979457

RESUMO

Lateral canthal lines or crow's feet lines (CFL) may be treated with onabotulinumtoxinA. We identified several key concepts important to understanding the use of onabotulinumtoxinA for treatment of moderate-to-severe CFL. To contextualize and integrate data on the recommended dose and injection patterns of onabotulinumtoxinA for treatment of CFL, we summarized data from pivotal clinical studies in the development of onabotulinumtoxinA for treatment of CFL. Data from key studies of onabotulinumtoxinA for CFL are presented. The efficacy and safety of onabotulinumtoxinA treatment of moderate-to-severe CFL were evaluated in 2 randomized, controlled phase 3 studies comprising 1362 patients. The 24U total dose of onabotulinumtoxinA used in these studies was based on a phase 2 dose-ranging trial. Two injection patterns were available to investigators; each involved 3 injection sites per side in the lateral orbicularis oculi muscle. A cross-sectional analysis of photographs from the phase 3 trials provided detailed information on the frequency of 4 distinct CFL patterns. In the primary efficacy analysis for each phase 3 trial, CFL responder rates were significantly greater with onabotulinumtoxinA vs placebo at day 30 (P< .001). Eyelid edema (1%) was the only adverse event reported in ≥ 1% of patients receiving onabotulinumtoxinA, occurring more frequently with onabotulinumtoxinA than with placebo. The studies showed that onabotulinumtoxinA is effective and generally well-tolerated for CFL treatment. Additionally, 2 different injection patterns allow physicians to tailor treatment based on a patient's CFL pattern.


Assuntos
Inibidores da Liberação da Acetilcolina/uso terapêutico , Toxinas Botulínicas Tipo A/uso terapêutico , Técnicas Cosméticas , Músculos Faciais/efeitos dos fármacos , Envelhecimento da Pele/efeitos dos fármacos , Inibidores da Liberação da Acetilcolina/administração & dosagem , Inibidores da Liberação da Acetilcolina/efeitos adversos , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Estudos Transversais , Relação Dose-Resposta a Droga , Humanos , Injeções Intramusculares , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
6.
Dermatol Surg ; 41 Suppl 1: S293-301, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26618456

RESUMO

BACKGROUND: Hyaluronic acid gels are increasingly used for augmentation of the lips. OBJECTIVE: To assess the safety and effectiveness of Juvéderm Ultra XC, a 24 mg/mL hyaluronic acid gel containing 0.3% (wt/wt) lidocaine (HYC-24L), for augmentation of the lips. METHODS: This ongoing, multicenter, single-blind study randomized 213 subjects to the treatment group (n = 157) or concurrent no-treatment control group that received delayed treatment (n = 56). The primary effectiveness endpoint was the responder rate (≥1 point improvement from baseline) based on the blinded evaluating investigator's assessment of the subject's overall lip fullness (or fullness of the eligible lip) using the validated Allergan 5-point Lip Fullness Scale. To meet this endpoint, the treatment group had to have a responder rate ≥60% and significantly greater than the treatment control group at Month 3. RESULTS: The primary endpoint was met, with a 79.1% responder rate for the treatment group and 26.1% for the treatment control group (p < 0.0001). More than half of subjects (56.4%) maintained treatment response for 12 months. Common injection site responses were swelling, bruising, and firmness; most were of mild or moderate severity. CONCLUSION: HYC-24L is safe and effective for aesthetic lip augmentation, with results lasting up to 1 year.


Assuntos
Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Lábio , Satisfação do Paciente , Rejuvenescimento , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Técnicas Cosméticas , Feminino , Seguimentos , Humanos , Injeções Intradérmicas , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Adulto Jovem
7.
Dermatol Surg ; 40(11): 1181-90, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25347451

RESUMO

BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
8.
J Clin Aesthet Dermatol ; 6(11): 32-8, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24307923

RESUMO

OBJECTIVE: To evaluate treating epidermal melasma using a 4% hydroquinone skin care system plus tretinoin 0.05% cream. DESIGN: Multicenter open-label study with all patients receiving above-mentioned treatment for up to 24 weeks. SETTING: Private dermatology and plastic surgery clinics and clinical research facilities. PARTICIPANTS: Thirty-seven adult females with moderate or marked epidermal melasma, melasma pigmentation of mild-to-marked intensity and Fitzpatrick skin type III to VI. MEASUREMENTS: Melasma severity melasma pigmentation intensity melasma improvement, patient satisfaction, quality-of-life measures, erythema, dryness, peeling, burning/stinging. RESULTS: No patient discontinued due to lack of efficacy or treatment-related adverse events. Treatment was associated with a significant reduction from baseline in melasma severity and melasma pigmentation intensity from Week 4 onward (P≤0.001), and 100 percent of patients showed improvement from Week 8 onward. At Week 24, 100 percent of patients were "satisfied" or "very satisfied" with the overall effectiveness of their treatment. Patients' quality of life also improved (e.g., the proportion of patients feeling embarrassed or self-conscious about their skin "a lot" or "very much" declined from 78 percent at baseline to four percent at Week 24). Mean and median scores for erythema, dryness, peeling, and burning/stinging did not exceed trace levels. CONCLUSION: Treating moderate-to-severe melasma using the 4% hydroquinone skin care system plus 0.05% tretinoin can significantly reduce the severity of melasma and the intensity of melasma pigmentation within four weeks. Treatment was generally well tolerated and associated with an improved quality of life and high levels of patient satisfaction.

9.
Aesthet Surg J ; 33(5): 705-12, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23671210

RESUMO

BACKGROUND: A device to assist in the delivery of dermal filler may achieve reductions in patient discomfort and adverse events, as well physician fatigue. It may also increase the accuracy of material placement. OBJECTIVES: The authors assess the safety and performance of the Artiste Assisted Injection System (Nordson Micromedics, St Paul, Minnesota) in normal therapeutic use compared with the standard manual administration of dermal fillers. METHODS: At 3 study sites, a total of 52 patients (48 women and 4 men) received bilateral full-correction injections of dermal fillers into randomized nasolabial folds (NLF). Injection into 1 NLF was made via Artiste, and injection into the other NLF was made via manual delivery. Immediately posttreatment and through 29 days, physician investigators, patients, and blinded evaluators recorded treatment durations and volumes, evaluated designated posttreatment characteristics using questionnaires, and documented adverse events (AE) and differences in cosmetic effects. RESULTS: Mean filler volume was 1.25 mL for the Artiste-treated NLF and 1.29 mL for manually treated NLF. One investigator used significantly less volume with Artiste than with manual injection (0.95 mL vs 1.12 mL; P = .001). Blinded evaluators rated Wrinkle Severity Rating Scale (WSRS) results as "identical" in 81% of patients. Investigator questionnaires showed a clear and statistically significant preference for Artiste over manual injection in all parameters (P < .001). CONCLUSIONS: The Artiste device is a viable option for physicians seeking a continuous-flow, injection-assisted device for ease of treatment, better accuracy, and improved results.


Assuntos
Técnicas Cosméticas/instrumentação , Ácido Hialurônico/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Desenho de Equipamento , Segurança de Equipamentos , Estética , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Sulco Nasogeniano , Segurança do Paciente , Satisfação do Paciente/estatística & dados numéricos , Valores de Referência , Método Simples-Cego , Envelhecimento da Pele/fisiologia , Estatísticas não Paramétricas , Resultado do Tratamento , Adulto Jovem
10.
Dermatol Surg ; 38(7 Pt 1): 1025-31, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22563723

RESUMO

OBJECTIVES: Macular seborrheic keratoses (SK) are common, benign growths. A novel fractionated 1927-nm thulium fiber laser was selected to investigate efficacy and safety in the clearance of macular SK in nonfacial areas at a private dermatologic laser center. STUDY DESIGN: Six subjects (average age 56.8 ± 9.5) with at least four 3-mm or larger macular SK on one extremity, neck, or chest were enrolled and provided informed consent. Subjects received three treatments at 3- to 4-week intervals. Subjects were treated at settings of 10 to 20 mJ with 30% to 55% surface area coverage and four to eight passes at each session. Investigators performed a global extremity SK count, an SK count within a 5- by 5-cm (25 cm(2)) square on transparency mapping, and lesion thickness grading. Side effects were assessed. Patients rated pain using a visual analog scale. RESULTS: At baseline, average global SK count was 43.2 ± 27.3. At 1-month follow-up, 20.7 ± 16.6 lesions remained. At 3- and 6-month follow-up, 17.7 ± 23.8 and 14.7 ± 18.6 lesions remained, respectively. A decrease in thickness and SK counts within the 5- by 5-cm square was also observed. Moderate erythema and mild edema were post-treatment responses. CONCLUSION: Nonablative fractional resurfacing using the 1927-nm thulium fiber laser is a safe and effective treatment modality to decrease nonfacial macular SK.


Assuntos
Ceratose Seborreica/cirurgia , Lasers de Estado Sólido/uso terapêutico , Idoso , Edema/etiologia , Eritema/etiologia , Humanos , Ceratose Seborreica/patologia , Lasers de Estado Sólido/efeitos adversos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Túlio , Resultado do Tratamento
11.
Dermatol Surg ; 38(2): 199-206, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22093448

RESUMO

BACKGROUND: A 1,927-nm wavelength was recently added to the 1,550-nm erbium-doped fiber laser. This wavelength possesses a higher absorption coefficient for water than the 1,550-nm, conferring greater ability to target epidermal processes such as dyschromia. OBJECTIVE: To evaluate the efficacy and safety of a novel 1,927-nm fractional thulium fiber laser in the treatment of melasma. METHODS: Fourteen patients underwent three to four laser treatments (at 4-week intervals) at pulse energies of 10 to 20 mJ and total densities of 252 to 784 microscopic treatment zones per cm(2) (6-8 passes) using a 1,927-nm thulium fiber laser. Three blinded assessors and the patients evaluated clinical improvement of treatment areas at 1-, 3-, and 6-month follow-ups. Side effects were assessed, and pain was scored using a visual analog scale (0-10). RESULTS: A statistically significant 51% reduction in MASI score was observed at 1-month post 3 to 4 laser treatments. A 33% (p = .06) and 34% (p = .07) reduction in Melasma Area and Severity Index score was observed at the 3- and 6-month follow-up visits, respectively. Skin responses observed after treatment were moderate erythema and mild edema. No scarring or postinflammatory hyper- or hypopigmentation was observed. CONCLUSION: The 1,927-nm fractional thulium fiber laser is a safe, effective treatment for melasma.


Assuntos
Terapia a Laser , Lasers de Estado Sólido , Melanose/terapia , Adulto , Feminino , Humanos , Terapia a Laser/efeitos adversos , Masculino , Pessoa de Meia-Idade
12.
Facial Plast Surg Clin North Am ; 19(2): 347-59, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21763995

RESUMO

Nonablative procedures for facial rejuvenation have become increasingly popular. One such method to improve laxity and diminish rhytids is monopolar capacitively coupled radiofrequency (MRF). The authors discuss clinical studies using MRF. The authors also discuss their clinical experiences as well as recommendations for optimal results. MRF using the Thermage CPT system (Solta Medical, Hayward, California) offers minimal downtime with a favorable side-effect profile. Although there are many radiofrequency devices on the market for aesthetic use, MRF has the most clinical trials to date to support its use as an effective, evidence-based modality to improve rhytids and tighten the skin.


Assuntos
Terapia por Estimulação Elétrica/métodos , Rejuvenescimento , Ritidoplastia/métodos , Envelhecimento da Pele , Blefaroplastia/métodos , Terapia Combinada , Contraindicações , Humanos , Terapia a Laser , Fotografação , Complicações Pós-Operatórias , Ritidoplastia/instrumentação
13.
Dermatol Surg ; 37(5): 572-95, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21492309

RESUMO

BACKGROUND: Pigmented lesions include solar lentigines, seborrheic keratoses, dermatosis papulosa nigra, ephelides, café-au-lait macules, nevus spilus, Becker's nevus, postinflammatory hyperpigmentation, melasma, nevocellular nevi, congenital nevi, junctional and compound melanocytic nevi, nevus of Ota and Ito, Hori's nevus, and blue nevi. Advances in laser technology have resulted in the ability to treat pigmented lesions with greater safety and efficacy. OBJECTIVE: To review the literature on the use of cutaneous laser treatments for pigmented lesions using Medline. RESULTS: The literature cited the use of various lasers to treat pigmented lesions, including argon, carbon dioxide, erbium-doped yttrium aluminum garnet, Q-switched, long-pulsed ruby, alexandrite, diode, and fractional lasers. For each lesion, we describe the efficacy of laser treatments, treatment intervals, and settings used for a variety of diagnoses. CONCLUSION: The treatment of pigmented lesions continues to evolve as new laser technology emerges and improvements in existing devices are made. The ability to treat pigmented lesions with greater efficacy and safety has resulted from recent advances in laser technology.


Assuntos
Terapia a Laser/métodos , Transtornos da Pigmentação/cirurgia , Humanos , Cuidados Intraoperatórios
14.
J Drugs Dermatol ; 10(2): 165-70, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21283921

RESUMO

OBJECTIVE: Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5% cream using two two-week or three-week cycles of daily dosing. METHODS: Adults with five to 20 baseline actinic keratoses who achieved complete clearance at the eight-week post-treatment visit in four phase 3 placebo-controlled treatment studies were followed for an additional 12 months. RESULTS: For imiquimod 3.75% and 2.5% cream, respectively, complete clearance was sustained for 12 months in 17/42 (40.5%) and 13/39 (33.3%) subjects from the two-week cycle studies, and in 23/48 (47.9%) and 16/37 (43.2%) subjects from the three-week cycle studies. There were no safety concerns during the follow-up. CONCLUSION: In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new) was sustained in ≥ 40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.


Assuntos
Aminoquinolinas/administração & dosagem , Ceratose Actínica/tratamento farmacológico , Adulto , Aminoquinolinas/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Face , Humanos , Imiquimode , Masculino , Couro Cabeludo , Fatores de Tempo , Resultado do Tratamento
15.
Dermatol Surg ; 37(3): 342-8, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21342312

RESUMO

BACKGROUND: A 1,927-nm wavelength was recently added to the 1,550-nm erbium-doped fiber laser. This wavelength possesses a higher absorption coefficient for water than the 1,550-nm, conferring greater ability to target epidermal processes. OBJECTIVE: To evaluate the efficacy and safety of a novel 1,927-nm fractional thulium fiber laser in the treatment of nonfacial photodamage. METHODS: Nine participants with nonfacial photodamage underwent three laser treatments (at 3- to 4-week intervals) at pulse energies of 10 to 20 mJ and 30% to 55% surface area coverage (4-8 passes) with a 1,927-nm thulium fiber laser. A blinded assessor and participants evaluated clinical improvement of treatment areas at 1-month follow-up using a quartile grading scale (0-4). RESULTS: Nine participants with a total of 12 treatment areas completed three treatments and the 1-month follow-up visit. At follow-up, a blinded assessor rated mean improvement in photodamage as 3.25 ± 1.0 and lentigines as 3.33 ± 0.9 on a scale of 0 to 4 (0=none, 1=1-25%, 2=26-50%, 3=51-75%, and 4=76-100% improvement). Skin responses observed after treatment were moderate erythema, mild edema, itching, and desquamation. No scarring or postinflammatory hyper- or hypopigmentation was observed. CONCLUSION: The 1,927-nm fractional thulium fiber laser is a safe, effective treatment for nonfacial photodamage. Dr. Polder is a principal investigator and Dr. Suzanne Bruce is a consultant for Solta Medical.


Assuntos
Terapia a Laser/métodos , Lasers , Envelhecimento da Pele/efeitos da radiação , Túlio , Idoso , Fracionamento da Dose de Radiação , Feminino , Seguimentos , Humanos , Lasers/efeitos adversos , Masculino , Pessoa de Meia-Idade , Fibras Ópticas , Projetos Piloto , Resultado do Tratamento
16.
Dermatol Surg ; 36 Suppl 3: 1819-29, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20969659

RESUMO

OBJECTIVE: To evaluate the safety and efficacy of a 2.5% polyacrylamide hydrogel in the aesthetic enhancement of nasolabial folds. METHODS AND MATERIALS: The safety and efficacy of a polyacrylamide hydrogel were compared with those of nonanimal stabilized hyaluronic acid (NASHA) in 315 subjects in a double-blind, randomized, multicenter, noninferiority trial with a 12-month follow-up. The primary efficacy end point was mean change in Wrinkle Assessment Scale (WAS) scores at 6 months. The primary safety end point was rate of serious adverse events (AEs) through 12 months after treatment. RESULTS: Polyacrylamide hydrogel was as effective as NASHA, and effectiveness persisted throughout the 12-month follow-up. Treatment-related AEs occurred with equal incidence; most were mild to moderate, transient, and related to injection procedure. One serious AE (infection) was thought to be related to treatment with polyacrylamide hydrogel; it resolved within 5 days after appropriate treatment. CONCLUSION: This 2.5% polyacrylamide hydrogel offers promise as a long-lasting soft tissue filler. It is well tolerated, as effective as NASHA in correction of nasolabial folds, and persistent. Longer evaluation is required to evaluate longer-term safety and demonstrate duration of effect beyond 12 months. This


Assuntos
Resinas Acrílicas/administração & dosagem , Próteses e Implantes/normas , Ritidoplastia/normas , Envelhecimento da Pele/efeitos dos fármacos , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
17.
J Drugs Dermatol ; 9(6): 607-13, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20645521

RESUMO

Rosacea is a leading reason why people seek the care of a dermatologist, accounting for nearly 7 million office visits annually. Pharmacologic treatments include both topical and oral medications, which are increasingly being used in combination, especially at the outset of therapy. This exploratory study assesses the safety, effectiveness and speed of onset of two common topical agents for the treatment of rosacea--azelaic acid gel (AzA) 15% and metronidazole gel 1%--used in conjunction with anti-inflammatory dose doxycycline (40 mg once daily). Men and women (n = 207) with mild-to-moderate papulopustular rosacea were enrolled and randomized to receive either AzA gel 15% twice daily plus doxycycline 40 mg once daily (AzA group) or metronidazole gel 1% once daily plus doxycycline 40 mg once daily (Metro group) for 12 weeks. Both regimens were safe, efficacious and well tolerated. Efficacy parameters revealed a possible trend toward greater and earlier benefit with the AzA-based regimen than with the metronidazole-based regimen. These findings warrant further investigation in a sufficiently powered study.


Assuntos
Ácidos Dicarboxílicos/administração & dosagem , Doxiciclina/administração & dosagem , Metronidazol/administração & dosagem , Rosácea/tratamento farmacológico , Administração Oral , Administração Tópica , Adulto , Idoso , Ácidos Dicarboxílicos/efeitos adversos , Doxiciclina/efeitos adversos , Quimioterapia Combinada , Feminino , Géis , Humanos , Masculino , Metronidazol/efeitos adversos , Pessoa de Meia-Idade
18.
J Am Acad Dermatol ; 59(4): 569-76, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18707799

RESUMO

BACKGROUND: The use of light-emitting diode light offers practical advantages in photodynamic therapy (PDT) with topical methyl-aminolevulinate (MAL) for management of actinic keratoses (AK). OBJECTIVE: We sought to evaluate the efficacy of MAL PDT using red light-emitting diode light. METHODS: We conducted a multicenter, double-blind, randomized study. A total of 49 patients with 363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47 patients with 360 AK lesions had vehicle cream similarly applied. The lesions were then illuminated (630 nm, light dose 37 J/cm2) with repeated treatment 1 week later. Complete lesion and patient (all lesions showing complete response) response rates were evaluated 3 months after last treatment. RESULTS: MAL PDT was superior (P<.0001) to vehicle PDT with respect to lesion complete response (86.2% vs 52.2%, odds ratio 6.9 [95% confidence interval 4.7-10.3]) and patient complete response (59.2% vs 14.9%, odds ratio 13.2 [95% confidence interval 4.1-43.1]). LIMITATIONS: The study population may not be representative of all patients with AK. CONCLUSION: MAL PDT using red light-emitting diode light is an appropriate treatment alternative for multiple AK lesions.


Assuntos
Ácido Aminolevulínico/análogos & derivados , Ceratose/tratamento farmacológico , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/administração & dosagem , Administração Tópica , Adulto , Idoso , Idoso de 80 Anos ou mais , Ácido Aminolevulínico/administração & dosagem , Método Duplo-Cego , Dermatoses Faciais/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dermatoses do Couro Cabeludo/tratamento farmacológico , Resultado do Tratamento
19.
J Drugs Dermatol ; 7(2 Suppl): s23-7, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18404868

RESUMO

The dermatologist has a variety of tools for improving the appearance of aging skin. These include injectable botulinum toxins and dermal fillers, laser treatments, chemical peels, and various topical agents, including cosmeceuticals. A combined approach using more than one facial rejuvenation tool is considered ideal for many patients, as it targets the various areas of the face and numerous dynamic and static changes associated with aging. A topical cosmeceutical regimen, such as one containing tretinoin and hydroquinone, can enhance the effects of facial rejuvenation procedures and encourage patients to adopt a daily cleansing and rejuvenation regimen that they can continue after the procedure to help maintain the aesthetic effects.


Assuntos
Técnicas Cosméticas , Rejuvenescimento , Envelhecimento da Pele/efeitos dos fármacos , Administração Tópica , Antioxidantes/administração & dosagem , Antioxidantes/uso terapêutico , Toxinas Botulínicas Tipo A/administração & dosagem , Combinação de Medicamentos , Estética , Face , Humanos , Hidroquinonas/administração & dosagem , Hidroquinonas/uso terapêutico , Ceratolíticos/administração & dosagem , Ceratolíticos/uso terapêutico , Terapia a Laser , Pele/efeitos dos fármacos , Tretinoína/administração & dosagem , Tretinoína/uso terapêutico
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