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1.
Am J Clin Dermatol ; 20(4): 593-604, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31111409

RESUMO

BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%). OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294). METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children's Dermatology Life Quality Index. RESULTS: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children's Dermatology Life Quality Index. CONCLUSIONS: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged. TRIAL REGISTRY: Clinicaltrials.gov NCT02553798.


Assuntos
Antagonistas Colinérgicos/administração & dosagem , Glicopirrolato/administração & dosagem , Hiperidrose/tratamento farmacológico , Índice de Gravidade de Doença , Administração Cutânea , Adolescente , Adulto , Axila , Criança , Antagonistas Colinérgicos/efeitos adversos , Método Duplo-Cego , Feminino , Seguimentos , Glicopirrolato/efeitos adversos , Humanos , Masculino , Qualidade de Vida , Sudorese/efeitos dos fármacos , Resultado do Tratamento , Adulto Jovem
2.
Am J Clin Dermatol ; 20(1): 135-145, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30378087

RESUMO

BACKGROUND: Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years. GT was evaluated for primary axillary hyperhidrosis in replicate, randomized, double-blind, vehicle-controlled, phase III trials. GT reduced sweating severity and production versus vehicle and was generally well tolerated. OBJECTIVE: Our objective was to evaluate patient-reported outcomes (PROs) from these trials. METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis ≥ 6 months, gravimetrically measured sweat production ≥ 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD) Item 2 severity score ≥ 4, and Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 3 were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. The 4-item ASDD, 6 Weekly Impact (WI) items, Patient Global Impression of Change (PGIC), HDSS, and Dermatology Life Quality Index (DLQI) were utilized. RESULTS: In the pooled population, 463 patients were randomized to GT and 234 to vehicle; 426 (92.0%) and 225 (96.2%) completed the trials. At baseline, most patients considered their axillary sweating to be at least moderate in severity, impact, and bothersomeness (ASDD items 2, 3, and 4, respectively). Improvement was substantially greater for GT than for vehicle at every study week, and, at week 4, ASDD scores improved from baseline by 62.6 versus 34.0% (severity), 65.5 versus 40.3% (impact), and 65.4 versus 39.0% (bothersomeness). Improvements favoring GT versus vehicle also occurred for WI items, PGIC, HDSS, and DLQI. CONCLUSIONS: PRO results demonstrated that GT reduced the disease burden of primary axillary hyperhidrosis. TRIAL REGISTRATION: Clinicaltrials.gov; ATMOS-1 (NCT02530281), ATMOS-2 (NCT02530294).


Assuntos
Antagonistas Colinérgicos/uso terapêutico , Glicopirrolato/uso terapêutico , Hiperidrose/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Adolescente , Adulto , Axila , Criança , Antagonistas Colinérgicos/farmacologia , Método Duplo-Cego , Feminino , Glicopirrolato/farmacologia , Humanos , Hiperidrose/diagnóstico , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Índice de Gravidade de Doença , Sudorese/efeitos dos fármacos , Resultado do Tratamento , Adulto Jovem
3.
J Am Acad Dermatol ; 80(1): 128-138.e2, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30003988

RESUMO

BACKGROUND: Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis. OBJECTIVE: Assess the efficacy and safety of GT for primary axillary hyperhidrosis. METHODS: ATMOS-1 and ATMOS-2 were replicate randomized, double-blind, vehicle-controlled, 4-week phase 3 trials. Patients were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. Coprimary endpoints were responder rate (≥4-point improvement from baseline) on item 2 (severity of sweating) of the Axillary Sweating Daily Diary (ASDD), which is a newly developed patient-reported outcome measure, and absolute change from baseline in axillary gravimetric sweat production at week 4. Safety evaluation included treatment-emergent adverse events. RESULTS: Pooled data, which are consistent with the individual trial results, show that significantly more GT-treated patients achieved an ASDD-Item 2 response than did those treated with vehicle (59.5% vs 27.6%), and they had reduced sweat production from baseline (-107.6 mg/5 min vs -92.1 mg/5 min) at week 4 (P < .001 for both coprimary end points). Most treatment-emergent adverse events were mild or moderate and infrequently led to discontinuation. LIMITATIONS: Short trial duration and inherent challenges in gravimetrically assessing sweat production. CONCLUSIONS: GT applied topically on a daily basis over 4 weeks reduced the severity of sweating as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in patients with primary axillary hyperhidrosis.


Assuntos
Antagonistas Colinérgicos/uso terapêutico , Glicopirrolato/uso terapêutico , Hiperidrose/tratamento farmacológico , Administração Tópica , Adulto , Axila , Antagonistas Colinérgicos/administração & dosagem , Método Duplo-Cego , Feminino , Glicopirrolato/administração & dosagem , Humanos , Masculino
4.
Dermatol Surg ; 43(11): 1321-1331, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28614091

RESUMO

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Fármacos Neuromusculares/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Toxinas Botulínicas Tipo A/administração & dosagem , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/administração & dosagem , Resultado do Tratamento
5.
J Clin Aesthet Dermatol ; 9(8): 12-8, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27672413

RESUMO

OBJECTIVE: To compare efficacy, tolerability, and safety of two concentrations of topical SB204 and vehicle twice daily for 12 weeks in the treatment of acne vulgaris. DESIGN: Randomized, double-blind, placebo-controlled, three-arm, Phase 2 study. SETTING: Dominican Republic, Panama, and Honduras. PARTICIPANTS: Subjects with acne, age 12 to 40, with 25 to 70 noninflammatory lesions, 20 to 40 inflammatory lesions, and a baseline Investigator's Global Assessment score of mild, moderate, or severe. MEASUREMENTS: The primary efficacy assessment was the absolute change in noninflammatory lesion counts. Other assessments included inflammatory lesion counts, success on dichotomized Investigator's Global Assessment, reported adverse events, physical examinations, laboratory testing, and tolerability. RESULTS: One hundred fifty-three subjects were randomized to vehicle (n=52), SB204 1% (n=51), or SB204 4% (n=50). When compared to vehicle, subjects treated with SB204 1% and SB204 4% had significantly greater mean percent reduction in noninflammatory lesions from baseline and subjects treated with SB204 4% had a significantly greater mean percent reduction in inflammatory lesion count from baseline at Week 12. There were no significant differences in the IGA success rates between groups. Both concentrations of SB204 were safe and well-tolerated. CONCLUSIONS: When compared to vehicle, both SB204 1% and SB204 4% significantly decreased the percentage of noninflammatory lesions and SB204 4% also significantly decreased the percentage of inflammatory lesions in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 1% and SB204 4% was safe and well-tolerated. Registry: clinicaltrials.gov (NCT01844752).

6.
J Allergy Clin Immunol ; 132(6): 1295-302, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23998657

RESUMO

BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS: BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS: One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS: These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting ß2-agonists.


Assuntos
Asma/terapia , Terapia por Estimulação Elétrica/métodos , Corticosteroides/uso terapêutico , Agonistas Adrenérgicos beta/uso terapêutico , Adulto , Asma/epidemiologia , Progressão da Doença , Resistência a Medicamentos , Serviços Médicos de Emergência/estatística & dados numéricos , Feminino , Seguimentos , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
7.
J Drugs Dermatol ; 12(7): 758-63, 2013 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-23884486

RESUMO

BACKGROUND: Itraconazole, approved for treatment of toenail fungal infection onychomycosis, provides antifungal activity at a dosage requiring once-daily (QD) administration of 2 100-mg capsules for 12 weeks. Utilizing the Meltrex® technology delivery system, a novel 200-mg formulation of itraconazole was developed delivering the same dosage as 2 capsules in a single tablet. METHODS: This phase 3, randomized, placebo-controlled trial investigated the noninferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsules dosed QD for 12 weeks, with a 40-week follow-up period. Clinical Cure (Investigator's Global Assessment plus mycological examination) was the primary outcome measure and Clinical Improvement was a secondary endpoint. Safety and efficacy of itraconazole 200-mg tablets were also compared with placebo. RESULTS: Significantly more patients in the intent-to-treat per-protocol populations on itraconazole (200-mg tablet or 2 100-mg capsules) achieved Complete Cure and Clinical Improvement compared with placebo. For both endpoints, itraconazole 200-mg tablet QD was noninferior to itraconazole 100-mg capsules and superior to placebo. All treatment groups demonstrated a similar safety profile with no new safety signals identified. LIMITATIONS: Absolute patient blinding was not possible; the number of tablets versus capsules differed, and the appearance of the active drugs could not be masked. However, efficacy was based on objective assessments from blinded investigators. CONCLUSIONS: Once-daily itraconazole 200-mg was well-tolerated, and may be an effective alternative to 2 itraconazole 100-mg capsules for the treatment of toenail onychomycosis. The convenience of a simpler dosing regimen may improve patient compliance


Assuntos
Antifúngicos/uso terapêutico , Dermatoses do Pé/tratamento farmacológico , Itraconazol/uso terapêutico , Onicomicose/tratamento farmacológico , Adulto , Antifúngicos/administração & dosagem , Antifúngicos/efeitos adversos , Cápsulas , Esquema de Medicação , Sistemas de Liberação de Medicamentos , Feminino , Seguimentos , Dermatoses do Pé/microbiologia , Dermatoses do Pé/patologia , Humanos , Itraconazol/administração & dosagem , Itraconazol/efeitos adversos , Masculino , Pessoa de Meia-Idade , Onicomicose/patologia , Método Simples-Cego , Comprimidos , Resultado do Tratamento
8.
Lancet Respir Med ; 1(3): 233-40, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-24429129

RESUMO

BACKGROUND: Few treatment options exist for patients with severe emphysema. We assessed the clinical benefits and safety of lung volume reduction coils (LVRCs) for the treatment of patients with severe emphysema with hyperinflation. METHODS: In a randomised study, we recruited patients with severe emphysema (aged ≥35 years) from three centres in the UK. Using a computer-generated randomisation sequence, we randomly allocated patients in a one-to-one ratio (block sizes of four and stratified by centre) to either LVRC treatment (treatment group) or best medical care (usual care group). The primary endpoint was the difference in response in the St George's Respiratory Questionnaire (SGRQ) between treatment and usual care groups at 90 days after final treatment (by intention-to-treat analysis). The trial is registered with ClinicalTrials.gov, number NCT01334307. FINDINGS: Between Jan 27, 2010, to Oct 25, 2011, we recruited and randomly allocated 47 patients: 23 to treatment and 24 to usual care (23 patients in each group were included in the intention-to-treat analysis). SGRQ response at 90 days after final treatment was greater in the treatment group than it was in the usual care group (between-group difference in change from baseline -8·36 points [95% CI -16·24 to -0·47]; p=0·04). We detected no between-group difference in serious adverse events. INTERPRETATION: Our findings suggest that treatment with endobronchial coils can improve quality of life for patients with severe emphysema and hyperinflation. FUNDING: PneumRx.


Assuntos
Broncoscopia , Pneumonectomia , Enfisema Pulmonar , Idoso , Antropometria , Broncoscopia/efeitos adversos , Broncoscopia/métodos , Teste de Esforço/métodos , Feminino , Fluoroscopia/métodos , Humanos , Pulmão/diagnóstico por imagem , Pulmão/fisiopatologia , Pulmão/cirurgia , Masculino , Pessoa de Meia-Idade , Pneumonectomia/efeitos adversos , Pneumonectomia/métodos , Enfisema Pulmonar/diagnóstico , Enfisema Pulmonar/fisiopatologia , Enfisema Pulmonar/psicologia , Enfisema Pulmonar/cirurgia , Qualidade de Vida , Recuperação de Função Fisiológica , Testes de Função Respiratória/métodos , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento
9.
Cephalalgia ; 30(11): 1336-45, 2010 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-20959428

RESUMO

OBJECTIVE: This study assessed the efficacy of diclofenac potassium for oral solution, a novel water-soluble buffered powder formulation, versus placebo for the acute treatment of migraine. Diclofenac potassium for oral solution has a time to maximum plasma concentration (Tmax) of 15 minutes, suggesting the potential for a rapid onset of therapeutic effects. METHODS: This was a randomized, double-blind, parallel-group, placebo-controlled study conducted in 23 US centers. Adult sufferers with an established migraine diagnosis according to the International Classification of Headache Disorders, second edition (ICHD-II), treated one moderate or severe attack with 50 mg diclofenac potassium for oral solution (dissolved in approximately 2 ounces of water; N=343) or matching placebo (N=347). Four co-primary endpoints included the percentage of subjects who at two hours post-treatment reported no headache pain, no nausea, no photophobia and/or no phonophobia. RESULTS: Significantly more subjects treated with diclofenac potassium for oral solution (N=343) achieved a two-hour pain-free response (25% vs. 10%, p<.001), no nausea (65% vs. 53%; p=.002), no photophobia (41% vs. 27%; p<.001) and no phonophobia (44% vs. 27%; p<.001) compared to placebo. Pain intensity differences between treatments were significantly lower in the diclofenac potassium oral solution group, starting at 30 minutes post-treatment (p=.013) with significant differences at all time points thereafter (p<.001). Twenty-four-hour sustained pain-free response favored diclofenac potassium oral solution treatment versus placebo (19% vs. 7%, p<.0001). The most common adverse event considered to be treatment related was nausea (diclofenac potassium for oral solution [4.6%]; placebo [4.3%]). CONCLUSIONS: This study shows that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute T(max) associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Diclofenaco/administração & dosagem , Transtornos de Enxaqueca/tratamento farmacológico , Administração Oral , Adolescente , Adulto , Idoso , Anti-Inflamatórios não Esteroides/efeitos adversos , Diclofenaco/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pós , Resultado do Tratamento , Adulto Jovem
10.
Am J Health Behav ; 34(1): 101-9, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-19663757

RESUMO

OBJECTIVE: To evaluate the safety and efficacy of sublingual lobeline sulfate for smoking cessation. METHODS: A multicenter (3 sites), double-blind, parallel, placebo-controlled, phase 3 smoking cessation trial of sublingual formulation of lobeline sulfate. A total of 750 smokers (250 per site) were randomized to either treatment (lobeline sulfate) or placebo with individual smoking cessation counseling lasting up to approximately 10 minutes. RESULTS: Efficacy revealed no statistical significance (P = 0.62) for lobeline sulfate as a smoking cessation aid. CONCLUSION: Sublingual formulation of lobeline sulfate does not appear to be an effective smoking cessation aid.


Assuntos
Aconselhamento , Lobelina/administração & dosagem , Agonistas Nicotínicos/administração & dosagem , Abandono do Hábito de Fumar/métodos , Fumar/tratamento farmacológico , Administração Sublingual , Adolescente , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Lobelina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Agonistas Nicotínicos/efeitos adversos , Abandono do Hábito de Fumar/psicologia , Resultado do Tratamento , Adulto Jovem
11.
Am J Respir Crit Care Med ; 181(2): 116-24, 2010 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-19815809

RESUMO

RATIONALE: Bronchial thermoplasty (BT) is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle. OBJECTIVES: To evaluate the effectiveness and safety of BT versus a sham procedure in subjects with severe asthma who remain symptomatic despite treatment with high-dose inhaled corticosteroids and long-acting beta(2)-agonists. METHODS: A total of 288 adult subjects (Intent-to-Treat [ITT]) randomized to BT or sham control underwent three bronchoscopy procedures. Primary outcome was the difference in Asthma Quality of Life Questionnaire (AQLQ) scores from baseline to average of 6, 9, and 12 months (integrated AQLQ). Adverse events and health care use were collected to assess safety. Statistical design and analysis of the primary endpoint was Bayesian. Target posterior probability of superiority (PPS) of BT over sham was 95%, except for the primary endpoint (96.4%). MEASUREMENTS AND MAIN RESULTS: The improvement from baseline in the integrated AQLQ score was superior in the BT group compared with sham (BT, 1.35 +/- 1.10; sham, 1.16 +/- 1.23 [PPS, 96.0% ITT and 97.9% per protocol]). Seventy-nine percent of BT and 64% of sham subjects achieved changes in AQLQ of 0.5 or greater (PPS, 99.6%). Six percent more BT subjects were hospitalized in the treatment period (up to 6 wk after BT). In the posttreatment period (6-52 wk after BT), the BT group experienced fewer severe exacerbations, emergency department (ED) visits, and days missed from work/school compared with the sham group (PPS, 95.5, 99.9, and 99.3%, respectively). CONCLUSIONS: BT in subjects with severe asthma improves asthma-specific quality of life with a reduction in severe exacerbations and healthcare use in the posttreatment period. Clinical trial registered with www.clinialtrials.gov (NCT00231114).


Assuntos
Asma/cirurgia , Brônquios/cirurgia , Hiper-Reatividade Brônquica/cirurgia , Broncoscopia , Eletrocoagulação , Adolescente , Adulto , Idoso , Asma/diagnóstico , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/diagnóstico , Qualidade de Vida , Adulto Jovem
12.
J Am Acad Dermatol ; 61(6): 971-6, 2009 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19828211

RESUMO

BACKGROUND: Pramiconazole is a broad-spectrum triazole antifungal with potential for oral treatment of pityriasis versicolor. OBJECTIVE: We sought to assess the efficacy and tolerability of 5 doses of pramiconazole relative to placebo. METHODS: This was a randomized, multicenter, double-blind, placebo-controlled, 28-day, dose-finding study. A total of 147 patients were randomized to treatment with placebo or one of 5 doses of pramiconazole; treatment lasted for 3 consecutive days. Efficacy was based on mycological response, severity of clinical signs and symptoms, and the Investigator Global Assessment of lesion clearance. RESULTS: A statistically significant (P < .001) dose-dependent effect was observed. When compared with placebo, a significant response (P < .05) was obtained for all but the lowest single dose of pramiconazole. There were no serious, treatment-related adverse events or other safety concerns. LIMITATIONS: The follow-up period was limited to 1 month after treatment onset. CONCLUSIONS: Pramiconazole is a well-tolerated and effective treatment for pityriasis versicolor and the most effective treatment regimen in this study included 200 or 400 mg taken once, and 200 mg taken once daily for 2 or 3 days.


Assuntos
Imidazóis/administração & dosagem , Tinha Versicolor/tratamento farmacológico , Triazóis/administração & dosagem , Administração Oral , Adulto , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Imidazóis/efeitos adversos , Masculino , Triazóis/efeitos adversos
13.
Pediatrics ; 124(3): e389-95, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-19706558

RESUMO

OBJECTIVE: Studies compared spinosad creme rinse and permethrin lice treatment under "actual-use" conditions for pediculosis capitis (head lice). SUBJECTS AND MATERIALS: Two phase-3, multicenter, randomized, evaluator/investigator-blinded studies compared 0.9% spinosad without nit-combing to 1% permethrin with combing (according to product instructions) in 1038 males and females aged > or =6 months. Spinosad-with-combing groups were included for descriptive, noninferential purposes only. Within 391 households, youngest members having > or =3 live lice were designated primary participants. All household members with lice received the same treatment. Participants administered product 1 to 2 times during the 21-day home-use period on the basis of complete lice eradication after a single use or the presence of lice requiring a second treatment. Scalp evaluations were performed at baseline, day 7, and day 14 (and day 21 for participants treated twice). The primary end point was the proportion of lice-free primary participants 14 days after last treatment. RESULTS: A total of 84.6% (study 1) and 86.7% (study 2) of spinosad-treated participants were lice free versus 44.9% and 42.9% permethrin-treated participants (P < .001). Most spinosad-treated participants required 1 application, whereas most permethrin-treated participants required 2 applications. Few adverse events were reported, but those occurring were mild to moderate, including eye irritation (permethrin), ocular hyperemia, and application-site erythema/irritation (both medications). No laboratory measure changed significantly. CONCLUSIONS: Spinosad, which did not require nit combing, was significantly more effective than permethrin in 2 studies reflecting actual-use conditions, and most spinosad-treated participants required only 1 application. Spinosad is a more convenient and effective treatment for pediculosis capitis.


Assuntos
Inseticidas/uso terapêutico , Infestações por Piolhos/tratamento farmacológico , Macrolídeos/uso terapêutico , Permetrina/uso terapêutico , Dermatoses do Couro Cabeludo/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Combinação de Medicamentos , Feminino , Humanos , Lactente , Inseticidas/efeitos adversos , Macrolídeos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Permetrina/efeitos adversos , Método Simples-Cego , Adulto Jovem
14.
Cutis ; 83(3): 146-54, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19363908

RESUMO

Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (P<.001) and noninflammatory (P<.001) lesion counts over 12 weeks. Treatment success rate (global severity score, 0 or 1) was significantly greater in the tretinoin gel 0.05% group compared with the vehicle group (P<.001). The efficacy rate of tretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(P<.001). Thus, tretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.


Assuntos
Acne Vulgar/tratamento farmacológico , Fármacos Dermatológicos/uso terapêutico , Tretinoína/uso terapêutico , Administração Tópica , Adolescente , Adulto , Idoso , Criança , Ensaios Clínicos Fase III como Assunto , Fármacos Dermatológicos/administração & dosagem , Feminino , Géis , Humanos , Masculino , Microesferas , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Tretinoína/administração & dosagem
15.
Cutis ; 79(6): 475-82, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17713152

RESUMO

Seborrheic dermatitis traditionally has been treated with topical steroids. In current practice, however, antifungal agents such as ketoconazole often are used because Malassezia yeasts are thought to play a role in the disease pathogenesis. Ketoconazole gel 2% has been developed for the once-daily treatment of seborrheic dermatitis. This gel is almost invisible after application, unlike ketoconazole cream, and may offer advantages in patient acceptance and adherence to treatment. Three randomized, double-blinded, vehicle-controlled, multicenter, parallel-group phase 3 studies evaluated the efficacy and tolerability of ketoconazole gel 2% compared with a vehicle gel in more than 900 subjects with moderate to severe seborrheic dermatitis who applied treatment for 14 days and were followed for an additional 14 days. Two of these studies also compared a combination gel containing ketoconazole 2% and desonide 0.05%, each active gel individually, and a vehicle control. Subjects were considered effectively treated if the erythema and scaling as well as investigator global assessment (IGA) scores decreased to 0 (or 1 if the baseline score was > or =3) by day 28. Pooled data from these studies showed that the proportion of effectively treated subjects was significantly greater in the ketoconazole gel 2% treatment group compared with the vehicle group (P < .001). The comparison of the combination gel to its individual components revealed that the efficacy of ketoconazole alone was comparable to the combination gel as well as desonide gel alone for up to 2 weeks after the end of treatment. These data suggest that once-daily ketoconazole gel 2% is an effective treatment for seborrheic dermatitis and a viable alternative to the ketoconazole cream 2% formulation.


Assuntos
Antifúngicos/administração & dosagem , Dermatite Seborreica/tratamento farmacológico , Cetoconazol/administração & dosagem , Administração Tópica , Ensaios Clínicos Fase III como Assunto , Dermatite Seborreica/microbiologia , Dermatite Seborreica/patologia , Géis , Humanos , Resultado do Tratamento
16.
Cutis ; 77(2): 113-20, 2006 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16570675

RESUMO

Diaper dermatitis (DD) complicated by candidiasis is a common problem in diaper-wearing infants and children. We report a double-blind, vehicle-controlled, parallel-group study evaluating the efficacy and safety of a low concentration of miconazole nitrate in a zinc oxide/petrolatum ointment for the treatment of DD complicated by candidiasis. Patients (N=330) who had DD with a severity score of 3 or higher were enrolled. Those patients with a baseline potassium hydroxide (KOH) preparation and a baseline culture specimen that both tested positive for Candida were retained for efficacy analysis (n=236). Miconazole nitrate 0.25% ointment or a zinc oxide/petrolatum vehicle control were applied to all clinically affected areas of patients with DD for 7 days at each diaper change and after bathing. A follow-up test-of-cure visit was conducted at day 14. Among the patients completing the study, the overall rate of cure (clinical cure plus microbiologic cure) was 23% for the miconazole nitrate group and 10% for the vehicle control group (P=.005); the rate of clinical cure (complete rash clearance, DD severity score=0 at day 14) was 38% for the miconazole nitrate group and 11% for the vehicle control group (P<.001); and the rate of microbiologic cure (no culture growth of Candida) was 50% for the miconazole nitrate group and 23% for the vehicle control group. The vehicle control resulted in mild improvement at day 3 but little or no subsequent improvement. The discontinuation rate due to clinical failure was substantially lower for the miconazole nitrate group (4%) than the vehicle control group (47%). The mean DD severity index score for the miconazole nitrate group was significantly lower from day 3 through day 14 compared with that of the vehicle control group (P<.001). Adverse events were assessed as either unlikely to be related to study medication or unrelated to study medication. By including only those patients with microbiologically confirmed Candida infection, the study population may not be fully indicative of patients treated for DD in routine clinical practice. Our data show that miconazole nitrate 0.25% ointment was well tolerated and significantly more effective than the zinc oxide/petrolatum vehicle control for treatment of DD complicated by candidiasis.


Assuntos
Antifúngicos/administração & dosagem , Candidíase Cutânea/tratamento farmacológico , Dermatite das Fraldas/tratamento farmacológico , Miconazol/administração & dosagem , Administração Tópica , Pré-Escolar , Fármacos Dermatológicos/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pomadas , Vaselina/administração & dosagem , Veículos Farmacêuticos , Índice de Gravidade de Doença , Resultado do Tratamento , Óxido de Zinco/administração & dosagem
17.
Headache ; 45(4): 283-92, 2005 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15836564

RESUMO

BACKGROUND: More than 50% of migraine sufferers rely on over-the-counter medications for the treatment of migraine. Along with other over-the-counter products, aspirin is considered by the US Headache Consortium to be an option for first-line migraine treatment. This study assessed the efficacy and tolerability of aspirin versus placebo for the acute treatment of a single acute attack of migraine. METHODS: This prospective, randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy of a single, 1000-mg dose of aspirin for the treatment of acute moderate to severe migraine, with or without aura. Subjects recorded all study evaluations in a diary at baseline and at .5, 1, 2, 3, 4, 5, 6, and 24 hours after treatment. Pain was rated on a 4-point ordinal scale from no pain to severe pain. The primary efficacy end point was headache response at 2 hours. Secondary efficacy parameters included reduction of nausea, photophobia and phonophobia, pain intensity difference, and headache recurrence at 24 hours. RESULTS: Of 485 subjects enrolled, 409 took study medication and 401 treated a confirmed migraine attack (201 with aspirin and 200 with placebo). Baseline demographic and migraine characteristics were not significantly different between groups. The 2-hour headache response rate was 52% with aspirin versus 34% with placebo (P<.001). Aspirin was significantly more effective than placebo for pain reduction beginning 1 hour after dosing (P<.001) and continuing throughout the 6-hour evaluation period. Significantly (P<.05), more subjects were pain free from the 1-hour evaluation through the 6-hour evaluation. Of the aspirin-treated subjects, 20% were pain free at 2 hours versus only 6% of placebo-treated subjects. At 24 hours, the headache recurrence rate was 21.8% for aspirin (23 of 105 subjects) and 27.7% for placebo (19 of 68 subjects). Only 34% of aspirin-treated subjects needed rescue medication at 24 hours compared with 52% of placebo-treated subjects (P<.001). Aspirin was well tolerated, and adverse events were not significantly different between groups. CONCLUSIONS: This study demonstrates that aspirin is safe and effective for treatment of acute migraine in appropriately selected patients.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Aspirina/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Doença Aguda , Método Duplo-Cego , Humanos , Estudos Prospectivos , Resultado do Tratamento
18.
J Clin Pharmacol ; 44(1): 67-72, 2004 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-14681343

RESUMO

Nanocrystal budesonide (nanobudesonide) is a suspension for nebulization in patients with steroid-responsive pulmonary diseases such as asthma. The pharmacokinetics and safety of the product were compared to those of Pulmicort Respules. Sixteen healthy volunteers were administered nanobudesonide 0.5 and 1.0 mg, Pulmicort Respules 0.5 mg, and placebo in a four-way, randomized crossover design. All nebulized formulations were well tolerated, with no evidence of bronchospasm. Nebulization times were significantly shorter for nanobudesonide compared to Pulmicort Respules. Because of a low oral bioavailability, plasma concentration of budesonide is a good marker of lung-delivered dose. The pharmacokinetics of nanobudesonide 0.5 and 1.0 mg were approximately dose proportional with respect to Cmax, AUC(0-t), and AUC(0-infinity). Nanobudesonide 0.5 mg and Pulmicort Respules 0.5 mg exhibited similar AUCs, suggesting a similar extent of pulmonary absorption. A higher Cmax was noted with nanobudesonide 0.5 mg, and the tmax was significantly different, suggesting a more rapid rate of drug delivery of nanobudesonide 0.5 mg than Pulmicort Respules. In conclusion, nebulized nanobudesonide 0.5 mg was safe in healthy volunteers, with a similar extent of absorption as Pulmicort Respules.


Assuntos
Asma/metabolismo , Broncodilatadores/farmacocinética , Budesonida/farmacocinética , Adulto , Broncodilatadores/efeitos adversos , Budesonida/efeitos adversos , Química Farmacêutica , Estudos Cross-Over , Feminino , Meia-Vida , Humanos , Masculino , Nebulizadores e Vaporizadores
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