RESUMO
BACKGROUND: Acne vulgaris commonly affects adults, adolescents, and preadolescents aged 9 years or older. OBJECTIVE: The objective of this study was to provide evidence-based recommendations for the management of acne. METHODS: A work group conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations. RESULTS: This guideline presents 18 evidence-based recommendations and 5 good practice statements. Strong recommendations are made for benzoyl peroxide, topical retinoids, topical antibiotics, and oral doxycycline. Oral isotretinoin is strongly recommended for acne that is severe, causing psychosocial burden or scarring, or failing standard oral or topical therapy. Conditional recommendations are made for topical clascoterone, salicylic acid, and azelaic acid, as well as for oral minocycline, sarecycline, combined oral contraceptive pills, and spironolactone. Combining topical therapies with multiple mechanisms of action, limiting systemic antibiotic use, combining systemic antibiotics with topical therapies, and adding intralesional corticosteroid injections for larger acne lesions are recommended as good practice statements. LIMITATIONS: Analysis is based on the best available evidence at the time of the systematic review. CONCLUSIONS: These guidelines provide evidence-based recommendations for the management of acne vulgaris.
Assuntos
Acne Vulgar , Antibacterianos , Peróxido de Benzoíla , Fármacos Dermatológicos , Ácidos Dicarboxílicos , Doxiciclina , Isotretinoína , Ácido Salicílico , Espironolactona , Humanos , Acne Vulgar/tratamento farmacológico , Isotretinoína/administração & dosagem , Isotretinoína/uso terapêutico , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/uso terapêutico , Peróxido de Benzoíla/administração & dosagem , Peróxido de Benzoíla/uso terapêutico , Ácidos Dicarboxílicos/administração & dosagem , Ácidos Dicarboxílicos/uso terapêutico , Espironolactona/administração & dosagem , Espironolactona/uso terapêutico , Doxiciclina/administração & dosagem , Doxiciclina/uso terapêutico , Ácido Salicílico/administração & dosagem , Ácido Salicílico/uso terapêutico , Medicina Baseada em Evidências/normas , Administração Oral , Retinoides/administração & dosagem , Retinoides/uso terapêutico , Tetraciclinas/administração & dosagem , Tetraciclinas/uso terapêutico , Adolescente , Minociclina/administração & dosagem , Minociclina/uso terapêutico , Criança , Administração Cutânea , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Combinados/uso terapêutico , Quimioterapia Combinada , Feminino , Corticosteroides/administração & dosagem , Corticosteroides/uso terapêutico , Injeções Intralesionais , Adulto , Cortodoxona/análogos & derivados , PropionatosRESUMO
BACKGROUND: While topical retinoids are a mainstay of acne treatment, acne can manifest differently in various skin types. The objective of these post hoc analyses from two pooled phase 3 studies was to examine efficacy and safety of tazarotene 0.045% and quality of life improvements in self-identified Caucasian adults with moderate-to-severe acne. METHODS: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion (N=1,614); a subset of adults (≥18 years) who self-reported Caucasian (White) race (n=645) were examined. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment (endpoint) success (≥2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear]). Quality of life, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed. RESULTS: At week 12, tazarotene lotion significantly reduced lesion counts by ~60% (least-squares mean percent changes from baseline, tazarotene vs vehicle: inflammatory, -61.2% vs -51.1%; noninflammatory, -59.7% vs -49.3%; P<0.001, both). Significantly more participants achieved treatment success with tazarotene lotion versus vehicle (P<0.001). Numerical improvements in quality-of-life domains were observed from baseline to week 12. Most TEAEs were unrelated to treatment, and rates of moderate-to-severe erythema decreased from baseline to week 12 with tazarotene treatment. CONCLUSIONS: Tazarotene 0.045% lotion was efficacious and well tolerated over 12 weeks and led to quality-of-life improvements in Caucasian adults with moderate-to-severe acne. These results, along with those from patients with skin of color, demonstrate that once daily tazarotene 0.045% lotion is an effective and well-tolerated treatment option regardless of race or skin color.J Drugs Dermatol. 2022;21(10):1061-1069. doi:10.36849/JDD.6834.
Assuntos
Acne Vulgar , Fármacos Dermatológicos , Ácidos Nicotínicos , Acne Vulgar/diagnóstico , Acne Vulgar/tratamento farmacológico , Acne Vulgar/etiologia , Administração Cutânea , Adulto , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Emolientes/uso terapêutico , Emulsões/uso terapêutico , Humanos , Qualidade de Vida , Retinoides/uso terapêutico , Índice de Gravidade de Doença , Creme para a Pele/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Females aged ≥25 years may have acne with different etiology, presentation, burden, and treatment response than females 18–24 years. This post hoc analysis investigated efficacy and safety of tazarotene 0.045% lotion in females ≥18 years or ≥25 years of age. METHODS: In two phase 3 double-blind studies, participants 9 years of age and older with moderate-to-severe acne were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Pooled data were analyzed for females aged ≥18 years (n=744) or ≥25 years (n=335). Assessments included inflammatory/noninflammatory lesion counts, treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of 0 [clear] or 1 [almost clear]), Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability. RESULTS: At week 12, tazarotene-treated females in both age groups had greater reductions from baseline versus vehicle in inflammatory (≥18 years: 60.6% vs 53.7% [P<0.01]; ≥25 years: 60.9% vs 57.3% [P>0.05]) and noninflammatory lesions (59.0% vs 48.4% and 61.1% vs 48.8%; P<0.01, both). Rates of treatment success were greater with tazarotene versus vehicle; this difference was significant for females ≥18 years. Acne-QoL improvements were similar across age groups and generally greater with tazarotene than vehicle. TEAEs were mostly mild to moderate in severity. No age-related trends for safety or tolerability were observed. CONCLUSIONS: Tazarotene 0.045% lotion demonstrated comparable efficacy, improvement in quality of life, and safety in adult females aged ≥18 or ≥25 years with moderate-to-severe acne. This cosmetically elegant lotion is a well-studied and important treatment option for all patients, particularly adult females. J Drugs Dermatol. 2022;21(5):587-595. doi:10.36849/JDD.6876.
Assuntos
Acne Vulgar , Fármacos Dermatológicos , Ácidos Nicotínicos , Acne Vulgar/diagnóstico , Acne Vulgar/tratamento farmacológico , Acne Vulgar/etiologia , Administração Cutânea , Adolescente , Adulto , Criança , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Emolientes/uso terapêutico , Emulsões/uso terapêutico , Excipientes , Feminino , Humanos , Ácidos Nicotínicos/efeitos adversos , Qualidade de Vida , Índice de Gravidade de Doença , Creme para a Pele/efeitos adversos , Resultado do TratamentoRESUMO
In 2017, a National Rosacea Society Expert Committee developed and published an updated classification of rosacea to reflect current insights into rosacea pathogenesis, pathophysiology, and management. These developments suggest that a multivariate disease process underlies the various clinical manifestations of the disorder. The new system is consequently based on phenotypes that link to this process, providing clear parameters for research and diagnosis as well as encouraging clinicians to assess and treat the disorder as it may occur in each individual. Meanwhile, a range of therapies has become available for rosacea, and their roles have been increasingly defined in clinical practice as the disorder has become more widely recognized. This update is intended to provide a comprehensive summary of management options, including expert evaluations, to serve as a guide for tailoring treatment and care on an individual basis to achieve optimal patient outcomes.
Assuntos
Rosácea/diagnóstico , Rosácea/terapia , HumanosRESUMO
BACKGROUND: There has been an increasing interest in gender differences both in the pathogenesis and treatment of acne vulgaris (acne). However, while acne prevalence among adolescents is comparable across sexes, acne is much more common in adult women than in adult men which has been largely ignored. Acne is likely less common in adult men because of the declining rate of sebum secretion observed with increasing age, and yet it can be more severe than in adult women. In addition, adherence to topical medications is especially poor in adult men where tactile and sensory perceptions are low. The first lotion formulation of tazarotene was developed using polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tazarotene formulations. OBJECTIVE: To evaluate the efficacy and safety of a new tazarotene 0.045% lotion formulation based on polymeric emulsion technology in treating adult male subjects with moderate or severe acne, in comparison with adolescent males treated with the same tazarotene 0.045% lotion. METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-or-severe acne. Subjects (aged 10 and older, N=1614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear or almost clear). Quality of Life was assessed using the validated Acne-QoL scale. Safety, adverse events (AEs) were evaluated throughout; cutaneous tolerability (using a 4-point scale where 0=none and 3=severe) at each study visit. RESULTS: A total of 268 male subjects (85≥18 years old and 183<18 years old) were treated with tazarotene 0.045% lotion once-daily for 12 weeks. At week 12, percent reductions in inflammatory and noninflammatory lesions with tazarotene 0.045% lotion were 62.3% and 59.5% in the adult male population, compared with 49.4% (P=0.001) and 49.5% (P=0.016) in the adolescent male population. Treatment success was achieved by 33.0% of adult male subjects treated with tazarotene 0.045% lotion, compared with 21.6% in the adolescent male population (P=0.059). Quality of life (as assessed by Acne-QoL domain scores) was better in adolescent males at baseline. Improvements in QoL domain scores were similar to those seen in the overall study population, with greater absolute change in domain scores in the adult males. Improvement in acne symptom scores was significantly greater in adult males (P=0.029). Tazarotene 0.045% lotion was well-tolerated. The number of subjects reporting any AE in the adult male population was 11 (13.6%) compared with 39 (21.4%) in the adolescent male population. There was only one (1.2%) treatment-related AE (application site pain) reported in the adult males compared with 11 (6.0%) in the adolescent males, where the most common treatment-related AEs were application site pain (3.3%), dryness (1.1%), and erythema (1.1%). Mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment. CONCLUSIONS: Tazarotene 0.045% lotion provides greater efficacy and better tolerability in adult males (above 18 years old) than the adolescent male population with moderate-to-severe acne patients. J Drugs Dermatol. 2020;19(1):78-85. doi:10.36849/JDD.2020.3979
Assuntos
Acne Vulgar/tratamento farmacológico , Fármacos Dermatológicos/administração & dosagem , Ácidos Nicotínicos/administração & dosagem , Acne Vulgar/patologia , Administração Cutânea , Adolescente , Adulto , Fatores Etários , Criança , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Humanos , Masculino , Ácidos Nicotínicos/efeitos adversos , Qualidade de Vida , Índice de Gravidade de Doença , Creme para a Pele , Resultado do Tratamento , Adulto JovemRESUMO
Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.
Assuntos
Clobetasol/análogos & derivados , Fármacos Dermatológicos/administração & dosagem , Psoríase/tratamento farmacológico , Creme para a Pele/administração & dosagem , Adulto , Idoso , Clobetasol/administração & dosagem , Clobetasol/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/diagnóstico , Índice de Gravidade de Doença , Fatores Sexuais , Creme para a Pele/efeitos adversos , Resultado do TratamentoRESUMO
Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.
Assuntos
Acne Vulgar/tratamento farmacológico , Ceratolíticos/uso terapêutico , Ácidos Nicotínicos/uso terapêutico , Acne Vulgar/etnologia , Acne Vulgar/patologia , Administração Cutânea , Criança , Método Duplo-Cego , Etnicidade , Feminino , Humanos , Ceratolíticos/administração & dosagem , Masculino , Ácidos Nicotínicos/administração & dosagem , Índice de Gravidade de Doença , Creme para a Pele , Resultado do TratamentoRESUMO
Background: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns. The first lotion formulation of tretinoin was developed using novel polymerized emulsion technology to provide an important alternative option to treat these acne patients who may be sensitive to the irritant effects of other tretinoin formulations. Objective: To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in a Hispanic population. Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout using a 4-point scale where 0=none and 3=severe. Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, compared with 51.1% and 38.7% with vehicle (P≤0.001) in the Hispanic population. Treatment success was achieved by 19.6% of subjects by week 12, compared with 12.7% on vehicle (P=0.015). The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) unrelated to treatment. Incidence of treatment-related AEs with tretinoin 0.05% lotion was lower than in the overall study population; the most frequently were application site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate at baseline and improved by week 12. There were slight transient increases in scaling and burning over the first four weeks. Hyperpigmentation severity reduced progressively with treatment. Conclusions: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well-tolerated, and all treatment-related AEs were both mild and transient in nature. J Drugs Dermatol. 2019;18(1):32-38.
Assuntos
Acne Vulgar/tratamento farmacológico , Dermatoses Faciais/tratamento farmacológico , Ceratolíticos/uso terapêutico , Tretinoína/uso terapêutico , Acne Vulgar/etnologia , Acne Vulgar/patologia , Administração Cutânea , Adolescente , Adulto , Criança , Método Duplo-Cego , Esquema de Medicação , Dermatoses Faciais/patologia , Feminino , Hispânico ou Latino , Humanos , Ceratolíticos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Creme para a Pele/administração & dosagem , Creme para a Pele/uso terapêutico , Resultado do Tratamento , Tretinoína/administração & dosagem , Adulto JovemRESUMO
BACKGROUND: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. METHODS: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. RESULTS: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%. LIMITATIONS: Study did not include subjects with BSA greater than 12. CONCLUSIONS: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.
Assuntos
Clobetasol/análogos & derivados , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Administração Cutânea , Clobetasol/administração & dosagem , Clobetasol/uso terapêutico , Fármacos Dermatológicos/administração & dosagem , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Creme para a Pele , Resultado do Tratamento , Estados UnidosRESUMO
An unmet need exists for a safe, tolerable, effective treatment for moderate to severe persistent facial erythema in patients with rosacea. This pivotal phase 3, multicenter, double-blind study evaluated the efficacy and safety of topical oxymetazoline in patients with facial erythema associated with moderate to severe rosacea. Patients were randomly assigned to treatment with oxymetazoline hydrochloride cream 1.0% or vehicle applied once daily for 29 days, and were followed for 28 days posttreatment. The primary efficacy outcome was having at least a 2-grade decrease from baseline on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment for rosacea facial redness (SSA) scales (composite success) at 3, 6, 9, and 12 hours postdose on day 29. Safety assessments included treatment-emergent adverse events (TEAEs) and posttreatment worsening of erythema (composite CEA/SSA increase of 1-grade severity from baseline; rebound effect). A total of 440 patients (mean age, 49.5 years; 78.9% females) were randomized (oxymetazoline, n=222; vehicle, n=218); most had moderate erythema. On day 29, significantly greater proportions of oxymetazoline recipients achieved the primary efficacy outcome at each time point (P less than 0.02) and overall (P less than 0.001) compared with vehicle recipients. The incidence of discontinuation due to TEAEs was low in both groups (oxymetazoline group, 1.8%; vehicle group, 0.5%). The most common TEAEs reported during the entire study period were application-site dermatitis, application-site erythema, and headache in the oxymetazoline group (1.4% each), and headache (0.9%) in the vehicle group. Following cessation of treatment, low proportions of patients experienced rebound effect (oxymetazoline group, 2.2%; vehicle group, 1.1%). Oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in patients with moderate to severe persistent facial erythema of rosacea.
J Drugs Dermatol. 2018;17(1):97-105.
.Assuntos
Agonistas alfa-Adrenérgicos/uso terapêutico , Eritema/tratamento farmacológico , Oximetazolina/uso terapêutico , Rosácea/tratamento farmacológico , Agonistas alfa-Adrenérgicos/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Dermatite/etiologia , Método Duplo-Cego , Eritema/etiologia , Feminino , Cefaleia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Oximetazolina/efeitos adversos , Recidiva , Rosácea/complicações , Índice de Gravidade de Doença , Creme para a Pele/efeitos adversos , Creme para a Pele/uso terapêutico , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Acne vulgaris (acne) is prevalent in individuals with skin of color, often with more frequent sequelae than in patients with lighter skin color. It is important to determine if there are also differences in response to medications. OBJECTIVE: This study evaluated the efficacy and tolerability of once-daily dapsone gel, 7.5% in patients with acne, stratified by Fitzpatrick skin phototype. METHODS: Data were pooled from 2 identically designed, phase 3, randomized, double-blind, vehicle-controlled studies in patients aged 12 years and older with moderate acne. Patients applied dapsone gel, 7.5% or vehicle once daily for 12 weeks. Efficacy was evaluated using the Global Acne Assessment Score (GAAS), lesion counts, and Acne Symptom and Impact Scale (ASIS); adverse events (AEs) and tolerability were also assessed. RESULTS: This analysis included 2216 patients with skin phototypes I-III and 2111 with types IV-VI. Dapsone gel, 7.5% significantly improved acne severity versus vehicle in both skin phototype subgroups, as determined by the percentage of patients with at least a 1-grade improvement in GAAS and mean change from baseline in GAAS (both, P less than .0001) at week 12 versus baseline. Dapsone gel, 7.5% significantly reduced inflammatory, comedonal, and total lesions in skin phototypes I-III (P less than .001) and IV-VI (P less than equal to .01) versus vehicle. Improvements in inflammatory lesions occurred first, with generally similar patterns of improvement seen over time in GAAS, comedonal lesions, and ASIS domains. The incidence of AEs was similar in both skin phototype subgroups and between study medications. Local scaling, erythema, stinging/burning, and dryness were rated "none" by most patients in both treatment groups and skin phototype subgroups. CONCLUSION: Once-daily dapsone gel, 7.5% was effective, safe, and well tolerated in patients with all skin phototypes who were treated for moderate acne. J Drugs Dermatol. 2018;17(2):160-167.
Assuntos
Acne Vulgar/diagnóstico , Acne Vulgar/tratamento farmacológico , Dapsona/administração & dosagem , Pigmentação da Pele/efeitos dos fármacos , Administração Tópica , Adolescente , Adulto , Anti-Infecciosos/administração & dosagem , Anti-Infecciosos/efeitos adversos , Criança , Dapsona/efeitos adversos , Método Duplo-Cego , Composição de Medicamentos , Feminino , Humanos , Masculino , Nasofaringite/induzido quimicamente , Pigmentação da Pele/fisiologia , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.
Assuntos
Acne Vulgar/tratamento farmacológico , Antibacterianos/uso terapêutico , Dermatoses Faciais/tratamento farmacológico , Tetraciclinas/uso terapêutico , Acne Vulgar/patologia , Administração Oral , Adolescente , Adulto , Antibacterianos/administração & dosagem , Criança , Método Duplo-Cego , Esquema de Medicação , Dermatoses Faciais/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Tetraciclinas/administração & dosagem , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I-VI.
METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV-VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were "none" or "mild" for all measures.
SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.
Clinicaltrials.gov registry: NCT01880320
J Drugs Dermatol. 2017;16(6):574-581.
.Assuntos
Acne Vulgar/tratamento farmacológico , Combinação Adapaleno e Peróxido de Benzoil/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Pele/patologia , Acne Vulgar/patologia , Combinação Adapaleno e Peróxido de Benzoil/administração & dosagem , Combinação Adapaleno e Peróxido de Benzoil/efeitos adversos , Administração Cutânea , Adolescente , Adulto , Criança , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Géis , Humanos , Inflamação/patologia , Masculino , Fenótipo , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: This randomized, double-blind, placebo-controlled, Phase 2 study compared efficacy, tolerability, and safety of SB204 once or twice daily to vehicle in the treatment of acne vulgaris. METHODS: Eligible subjects were to be between 12 and 40 years old, have facial acne vulgaris with 25 to 70 non-inflammatory lesions, 20 to 40 inflammatory lesions, no more than 2 nodules, and a baseline Investigator's Global Assessment (IGA) score of moderate or severe. The co-primary efficacy endpoints were the absolute change in inflammatory and non-inflammatory lesion counts and IGA success rate (baseline to week 12). Safety assessments included reported adverse events (AEs), physical examinations, and laboratory testing. Tolerability was evaluated by the investigators based on the occurrence and severity of erythema, scaling, dryness, pruritus, and burning/stinging. RESULTS: A total of 213 subjects were randomized: 27 subjects to vehicle once daily; 29 subjects to vehicle twice daily; 53 subjects to SB204 2% twice daily; 52 subjects to SB204 4% once daily; and 52 subjects to SB204 4% twice daily. When compared to vehicle, treatment with all 3 SB204 regimens significantly reduced the absolute inflammatory lesion count and SB204 4% once daily reduced the absolute non-inflammatory lesion count. Treatment with SB204 4% once daily demonstrated a significant reduction in percent inflammatory lesions by week 4. There were no significant differences in the IGA success rates between groups at the end of treatment. All treatment regimens of SB204 were found to be safe and well tolerated. CONCLUSIONS: When compared to vehicle, SB204 2% and SB204 4% significantly decreased the absolute inflammatory lesion count and SB204 4% once daily also significantly decreased the absolute non-inflammatory lesion count in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 2% and 4% was found to be safe and well tolerated. J Drugs Dermatol. 2016;15(12):1496-1502.
Assuntos
Acne Vulgar/diagnóstico , Acne Vulgar/tratamento farmacológico , Fármacos Dermatológicos/administração & dosagem , Doadores de Óxido Nítrico/administração & dosagem , Adolescente , Adulto , Criança , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Resultado do Tratamento , Adulto JovemRESUMO
As the pathophysiology of acne is complex and multifactorial, the continued influx of new basic science and clinical information requires careful analysis before drawing conclusions about what truly contributes to the development and progression of this chronic disease. Our objective is to review the latest evidence and highlight a number of important perspectives on the pathophysiology of acne. An improved understanding of acne pathogenesis should lead to more rational therapy and a better understanding of the role of P acnes opens new perspectives for the development of new treatments and management. Further research may be directed at targeting receptors, adhesion molecules, cytokines, chemokines or other pro-inflammatory targets implicated in the activation of immune detection and response (i.e., toll-like receptors [TLRs], protease-activated receptors [PARs]) that appear to contribute to the pathophysiology of acne. Therapeutic options that reduce the need for topical and/or oral antibiotic therapy for acne are welcome as bacterial resistance to antibiotics is a clinically relevant concern both in the United States and globally.
Assuntos
Acne Vulgar/diagnóstico , Acne Vulgar/etiologia , Acne Vulgar/terapia , Antibacterianos/administração & dosagem , Fármacos Dermatológicos/administração & dosagem , Humanos , Estresse Oxidativo/efeitos dos fármacos , Estresse Oxidativo/fisiologia , Propionibacterium acnes/efeitos dos fármacos , Propionibacterium acnes/isolamento & purificação , Sebo/metabolismoRESUMO
OBJECTIVE: To evaluate efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in moderate to severe acne vulgaris. METHODS: A total of 498 patients, 12-40 years of age, were randomized to receive clindamycin-BP 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts, Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness. RESULTS: Clindamycin-BP 3.75% demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Clindamycin-BP 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP 3.75% because of adverse events. LIMITATIONS: Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients. CONCLUSIONS: Clindamycin-BP 3.75% provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile.
Assuntos
Acne Vulgar/diagnóstico , Acne Vulgar/tratamento farmacológico , Antibacterianos/administração & dosagem , Peróxido de Benzoíla/administração & dosagem , Clindamicina/análogos & derivados , Índice de Gravidade de Doença , Administração Cutânea , Adolescente , Adulto , Química Farmacêutica , Criança , Clindamicina/administração & dosagem , Método Duplo-Cego , Esquema de Medicação , Combinação de Medicamentos , Feminino , Géis , Humanos , Masculino , Satisfação do Paciente , Resultado do Tratamento , Água , Adulto JovemRESUMO
BACKGROUND: Excessive sebum production is a factor in acne development. Tazarotene 0.045% lotion has demonstrated reductions in acne lesions and acne-induced sequelae. OBJECTIVE: Evaluate efficacy, changes in skin oiliness, and safety with tazarotene 0.045% lotion in participants with moderate-to-severe acne and oily skin. METHODS: In two phase 3, double-blind, 12-week studies (NCT03168321; NCT03168334), participants aged ≥ 9 years with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene 0.045% lotion or vehicle lotion (N = 1614). This pooled, post hoc analysis included only participants self-categorized with oily skin at baseline on the Acne-Specific Quality of Life questionnaire item 19 (scores: 0 [extremely oily] to 6 [not at all oily]). Inflammatory/noninflammatory lesion counts, treatment success, skin oiliness, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were evaluated. RESULTS: In all participants with oily skin (n = 793), tazarotene provided greater reductions in inflammatory/noninflammatory lesions (p < 0.001, both) and greater treatment success rates versus vehicle (p < 0.01) at week 12. Over two-thirds of polymeric lotion-treated participants had subjective skin oiliness reductions by week 12, with around a third reporting 'low/not' oily skin. Tazarotene TEAE rates were similar to the overall population. CONCLUSIONS: Once-daily treatment with tazarotene 0.045% polymeric emulsion lotion may help improve patient-perceived skin oiliness in those with moderate-to-severe acne.
Assuntos
Acne Vulgar , Fármacos Dermatológicos , Humanos , Tretinoína/uso terapêutico , Ceratolíticos/uso terapêutico , Qualidade de Vida , Índice de Gravidade de Doença , Creme para a Pele/uso terapêutico , Acne Vulgar/tratamento farmacológico , Acne Vulgar/patologia , Administração Cutânea , Resultado do Tratamento , Método Duplo-Cego , Emulsões , Fármacos Dermatológicos/efeitos adversosRESUMO
Objective: The condition of the skin can vary due to weather fluctuations. Therefore, this post-hoc analysis evaluated efficacy and safety of tazarotene 0.045% lotion in warmer versus colder months. Methods: In two Phase III, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene or vehicle lotion. The pooled population (N=1,614) was stratified by randomization date (warmer=May to September; colder=October to April). Evaluations included inflammatory/noninflammatory lesion counts, treatment success, adverse events, and safety/tolerability. Results: Tazarotene 0.045% lotion was similarly efficacious over colder and warmer months. Compared with vehicle, tazarotene demonstrated significantly greater least-squares mean absolute reductions from baseline to Week 12 in inflammatory (colder/warmer tazarotene vs. vehicle: -16.6/-15.8 vs. -13.2/-12.9) and noninflammatory lesions (-23.2/-22.6 vs. -17.5/-15.1); treatment success rates were also significantly higher (30.1/30.8% vs. 18.2/17.6%) (P<0.001, all). No strong seasonal trends in safety were observed, though tazarotene led to slightly more discontinuations (3.4% vs. 1.9%) and related adverse events (12.0% vs. 10.3%) in colder versus warmer months. Transient increases in scaling, erythema, and itching at Weeks 2 to 8 of tazarotene treatment were slightly higher in colder versus warmer months but returned to baseline/improved by Week 12. Limitations: Geographical variation across study sites can lead to varying temperatures and humidity within the same months. Conclusion: Tazarotene 0.045% lotion was efficacious and well tolerated for acne treatment, regardless of season. Year-round tolerability of tazarotene 0.045% lotion may be due to its lower tazarotene concentration and polymeric emulsion technology, which simultaneously delivers moisturizers/humectants/emollients to skin.
RESUMO
BACKGROUND: Acne in Hispanics is an increasing problem, presenting unique challenges. Although combination therapy is now a standard of care in acne, concerns exist with the increased potential irritation and dryness in this population and the potential for hyperpigmentation. There is a paucity of clinical studies that evaluate the efficacy and tolerability of acne medications in Hispanics. METHODS: A post-hoc analysis of efficacy and cutaneous tolerability in 458 Hispanic subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel, individual active ingredients and vehicle from two 12-week multicenter double-blind studies that enrolled 2813 subjects with moderate to severe acne. RESULTS: Median reductions in inflammatory lesions, noninflammatory, and total lesions (71.6%, 50.9% and 55.1%, respectively) were significantly greater with clindamycin phosphate 1.2%/BPO 2.5% gel versus the individual active ingredients and vehicle. Treatment success (35.6% "clear/almost clear") and patient satisfaction (83.2%) were also significantly greater than vehicle at week 12. Cutaneous tolerability was excellent with all mean scores less than or equal to 0.2 at week 12 (where 1=mild). CONCLUSIONS: Overall efficacy and tolerability with clindamycin phosphate 1.2%/BPO 2.5% gel were better in the Hispanic population compared to the total study population. Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was excellent.
Assuntos
Acne Vulgar/tratamento farmacológico , Peróxido de Benzoíla/uso terapêutico , Clindamicina/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Hispânico ou Latino , Acne Vulgar/patologia , Adolescente , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Antibacterianos/uso terapêutico , Peróxido de Benzoíla/administração & dosagem , Peróxido de Benzoíla/efeitos adversos , Criança , Clindamicina/administração & dosagem , Clindamicina/efeitos adversos , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Géis , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Índice de Gravidade de Doença , Pigmentação da Pele , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Most people with acne are at risk of developing acne scars, but the impact of these scars on patients' quality of life is poorly researched. OBJECTIVE: To assess the perspective of patients with acne scars and the impact of these scars on their emotional well-being and social functioning. METHODS: A 60-minute interview of 30 adults with acne scars informed and contextualized the development of a cross-sectional survey of 723 adults with atrophic acne scars. RESULTS: The main themes identified in the qualitative interviews included acceptability to self and others, social functioning, and emotional well-being. In the cross-sectional survey, 31.6%, 49.6%, and 18.8% of the participants had mild, moderate, and severe/very severe acne scarring. The survey revealed that 25.7% of the participants felt less attractive, 27.5% were embarrassed or self-conscious because of their scars, 8.3% reported being verbally and/or physically abused because of their scars on a regular basis, and 15.9% felt that they were unfairly dismissed from work. In addition, 37.5% of the participants believed that their scars affected people's perceptions about them, and 19.7% of the participants were very bothered about hiding their scars daily. Moreover, 35.5% of the participants avoided public appearances, and 43.2% felt that their scars had negatively impacted their relationships. LIMITATIONS: The temporal evaluation of the impact was not estimated. CONCLUSION: Even mild atrophic acne scarring can evoke substantial emotional, social, and functional concerns.