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1.
J Drugs Dermatol ; 23(6): 423-428, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38834211

RESUMO

INTRODUCTION: Micronized isotretinoin 0.4 to 0.8 mg/kg/day administered in 2 divided doses with or without meals is approved for the treatment of severe nodular acne in patients aged 12 years or older. Although practitioners may suggest once-daily dosing to increase patient compliance, supporting data are limited. METHODS: In this pilot study, patients aged 12 years or older with severe nodular acne (Investigator's Global Assessment [IGA] =>4 and >5 facial nodules) received once-daily micronized isotretinoin 0.4 to 0.8 mg/kg/day without food for 20 weeks. The coprimary efficacy endpoints were changes from baseline in nodular lesion count (NLC) and percentage of patients with a =>90% reduction in NLC at week 24. Secondary endpoints included percentage of patients achieving IGA 0/1; reductions in inflammatory lesion count (ILC) and noninflammatory lesion count (NILC); adverse events (AEs); and severity of erythema, dryness, peeling, oiliness, burning, and pruritus. Analyses included all enrolled patients with the last observation carried forward. RESULTS: Twenty-two of 24 patients completed the study. From baseline to week 24, NLC decreased by a median (quartile [Q]1, Q3) of 6 (5, 7), all patients experienced complete clearance of nodules, 23/24 (96%) patients achieved IGA 0/1, and ILC and NILC decreased by a mean +/- standard deviation of 97.8% +/- 5.7% and 98.4% +/- 6.2%, respectively (all P<0.0001). There were small, significant, early increases in the severity of erythema, dryness, and peeling; 2 patients experienced 3 AEs considered unrelated to treatment. CONCLUSIONS: Once-daily micronized isotretinoin administered without food was efficacious and well tolerated in patients with severe nodular acne.  J Drugs Dermatol. 2024;23(6):423-428.     doi:10.36849/JDD.7863.


Assuntos
Acne Vulgar , Fármacos Dermatológicos , Isotretinoína , Humanos , Isotretinoína/administração & dosagem , Isotretinoína/efeitos adversos , Acne Vulgar/tratamento farmacológico , Acne Vulgar/diagnóstico , Masculino , Feminino , Projetos Piloto , Adolescente , Resultado do Tratamento , Adulto , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Adulto Jovem , Esquema de Medicação , Criança , Índice de Gravidade de Doença , Administração Cutânea
2.
J Drugs Dermatol ; 23(6): 438-445, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38834223

RESUMO

Clindamycin is a lincosamide-derivate antibiotic that has been widely used both systemically and topically for approximately 5 decades. The antimicrobial profile of clindamycin primarily covers several gram-positive bacteria and anaerobic bacteria, with multiple clinical applications supported in the literature and with widespread real-world use. Topical clindamycin has been used primarily for the treatment of acne vulgaris, with both monotherapy and combination therapy formulations available commercially. This article reviews the use of clindamycin as a topical agent with emphasis on therapy for acne vulgaris, and addresses modes of action, reported anti-inflammatory properties that may relate to therapeutic outcomes, recommendations to avoid the emergence of antibiotic-resistant bacteria, tolerability and safety considerations, and published data from clinical studies completed over a span of several years. A discussion of a newly FDA-approved triple-combination formulation is also included.  J Drugs Dermatol. 2024;23(6):438-445.     doi:10.36849/JDD.8318.


Assuntos
Acne Vulgar , Administração Cutânea , Antibacterianos , Clindamicina , Humanos , Acne Vulgar/tratamento farmacológico , Clindamicina/administração & dosagem , Clindamicina/uso terapêutico , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Resultado do Tratamento , Farmacorresistência Bacteriana
3.
J Clin Aesthet Dermatol ; 17(5): 24-28, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38779372

RESUMO

Objective: We sought to review published literature on antibiotic and antiseptic use and resistance, and explore the utility of benzoyl peroxide in this capacity for dermatologic surgery. Methods: A literature review was performed to investigate the skin microbiome, guidelines on antibiotic and antiseptic use in dermatologic surgery, and the utility of benzoyl peroxide as an antiseptic. Results: Antiseptics are commonly used in dermatologic surgery to prepare surgical sites, and antibiotics are also employed by some physicians to prevent post-operative infection despite the potential for antibiotic resistance. Benzoyl peroxide, known for its high threshold for antibiotic resistance, has been successfully used in orthopedic surgery to prevent surgical site infection, especially in sebaceous areas of the skin which house a distinct microbiota. Limitations: Limitations to this review include lack of high-quality, adequately powered research and studies which evaluate the clinical impact of anti-septic use, particularly benzoyl peroxide use, in dermatologic surgery. Conclusion: Benzoyl peroxide may be a used as an antiseptic in dermatologic surgery of sebaceous areas to prevent post-operative infections, with a low likelihood of causing microbial resistance.

4.
Dermatol Ther (Heidelb) ; 14(5): 1211-1227, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38724841

RESUMO

INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12. CONCLUSIONS: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04214639 and NCT04214652.

5.
Int J Dermatol ; 63(6): 806-815, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38685118

RESUMO

BACKGROUND: Acne-induced hyperpigmentation (AIH) may accompany acne vulgaris (AV) inflammation in all skin phototypes. Trifarotene has shown depigmenting properties in vivo. This study evaluated trifarotene plus skincare because it is increasingly recognized that holistic AV management should include skincare and treatments. METHODS: This is a phase IV double-blind, parallel-group study of patients (13-35 years) with moderate AV and AIH treated with trifarotene (N = 60) or vehicle (N = 63) plus skincare regimen (moisturizer, cleanser, and sunscreen) for 24 weeks. Assessments included the AIH overall disease severity (ODS) score, post-AV hyperpigmentation index (PAHPI), exit interviews, photography, and acne assessments. Standard safety assessments were included. RESULTS: Trifarotene 50 µg/g cream improved significantly from baseline in ODS score versus vehicle (-1.6 vs. -1.1, P = 0.03) at Week 12, but scores were comparable between groups at Week 24 (primary endpoint). Trifarotene had a better reduction in PAHPI score at Week 24 (-18.9% vs. -11.3% vehicle, P < 0.01). Lesion count reductions were higher with trifarotene at Week 12 versus vehicle (P < 0.001) and at Week 24 (P < 0.05), as were IGA success rates versus vehicle at Weeks 12 (P < 0.05) and 24 (P < 0.05). Patients agreed that the skincare regimen contributed to less irritation, making treatment adherence easier. Photography showed improvements in pigmentation and erythema across all skin types. AEs were more common in the vehicle group versus trifarotene (30.2 vs. 16.7%, respectively). CONCLUSIONS: In all skin phototypes, there was more rapid improvement in the ODS and PAHPI scores with trifarotene by Weeks 12 and 24, respectively. The combination of trifarotene and skincare correlated with high patient satisfaction and adherence to the treatment protocol.


Assuntos
Acne Vulgar , Hiperpigmentação , Índice de Gravidade de Doença , Higiene da Pele , Protetores Solares , Adolescente , Adulto , Feminino , Humanos , Masculino , Adulto Jovem , Acne Vulgar/complicações , Acne Vulgar/tratamento farmacológico , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Método Duplo-Cego , Hiperpigmentação/etiologia , Hiperpigmentação/tratamento farmacológico , Hiperpigmentação/prevenção & controle , Retinoides , Higiene da Pele/métodos , Creme para a Pele/administração & dosagem , Pigmentação da Pele/efeitos dos fármacos , Pigmentação da Pele/efeitos da radiação , Protetores Solares/administração & dosagem , Minorias Étnicas e Raciais
6.
J Drugs Dermatol ; 23(4): 244-248, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38564396

RESUMO

Initially categorized as primarily a respiratory disease, COVID-19 can involve other organ systems and may have direct skin manifestations, including exanthems, morbilliform eruption, generalized urticaria, or pseudo-chilblains —commonly called “COVID Toes.” Frequent handwashing and prolonged wearing of face masks and shields in efforts to minimize transmission of SARS-CoV-2, the novel coronavirus that causes COVID, has given rise to indirect skin manifestations of COVID. “Maskne” and handwashing dermatitis are particularly common among healthcare workers. Characterized by skin inflammation, dryness, pruritus, and other symptoms, these conditions are fundamentally disorders of skin barrier dysfunction. This dysfunction may result from the combination of mechanical skin damage, changes in skin pH, reductions in skin lipids attributable to protection measures, and local alterations in the cutaneous microbiome. Strategies to manage these conditions focus on reversing and repairing skin barrier damage with preventative general measures, optimized skin care with the selection of proper products, eliminating irritant exposures, and avoiding certain medications, such as topical corticosteroids, that may further impair barrier function despite temporary improvement in signs and symptoms. J Drugs Dermatol. 2024;23(4):  doi:10.36849/JDD.7862.


Assuntos
COVID-19 , Dermatopatias , Humanos , COVID-19/prevenção & controle , SARS-CoV-2 , Pele , Higiene da Pele
7.
J Dermatolog Treat ; 35(1): 2325603, 2024 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38568005

RESUMO

Purpose: Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding gastrointestinal (GI) adverse events (AEs), real-world incidence of GI AEs with topical clindamycin is unknown. This review provides background information and an overview of safety data of topical clindamycin for treating AV.Materials and Methods: Available safety data from published literature, previously unpublished worldwide pharmacovigilance data, and two retrospective cohort studies were reviewed.Results and Conclusions: According to pharmacovigilance data, the rate of GI adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). Results from two retrospective medical record studies of patients with AV indicated that physicians prescribe topical clindamycin equally to patients with or without inflammatory bowel disease history, and that rates of pseudomembranous colitis in these patients were low. In 8 published pivotal clinical trials of topical clindamycin for AV, GI AEs were reported in 1.4% of participants. Limitations include under/inaccurate reporting of AEs or prescription data and limited generalizability. This review of published case reports, worldwide pharmacovigilance data, retrospective US prescription data, and clinical trials safety data demonstrates that the incidence of colitis in patients exposed to topical clindamycin is extremely low.


Assuntos
Acne Vulgar , Clindamicina , Humanos , Clindamicina/efeitos adversos , Estudos Retrospectivos , Acne Vulgar/tratamento farmacológico , Antibacterianos/efeitos adversos , Peróxido de Benzoíla/uso terapêutico
8.
JAMA Dermatol ; 160(6): 658-666, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38656294

RESUMO

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.


Assuntos
Ensaios Clínicos como Assunto , Consenso , Técnica Delphi , Rosácea , Rosácea/terapia , Rosácea/diagnóstico , Humanos , Ensaios Clínicos como Assunto/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Resultado do Tratamento
9.
Antibiotics (Basel) ; 13(3)2024 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-38534705

RESUMO

Clindamycin is a highly effective antibiotic of the lincosamide class. It has been widely used for decades to treat a range of skin and soft tissue infections in dermatology and medicine. Clindamycin is commonly prescribed for acne vulgaris, with current practice standards utilizing fixed-combination topicals containing clindamycin that prevent Cutibacterium acnes growth and reduce inflammation associated with acne lesion formation. Certain clinical presentations of folliculitis, rosacea, staphylococcal infections, and hidradenitis suppurativa are also responsive to clindamycin, demonstrating its suitability and versatility as a treatment option. This review describes the use of clindamycin in dermatological practice, the mechanism of protein synthesis inhibition by clindamycin at the level of the bacterial ribosome, and clindamycin's anti-inflammatory properties with a focus on its ability to ameliorate inflammation in acne. A comparison of the dermatologic indications for similarly utilized antibiotics, like the tetracycline class antibiotics, is also presented. Finally, this review addresses both the trends and mechanisms for clindamycin and antibiotic resistance, as well as the current clinical evidence in support of the continued, targeted use of clindamycin in dermatology.

10.
J Drugs Dermatol ; 23(2): 54-60, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38306124

RESUMO

BACKGROUND:  Cutaneous squamous cell carcinoma (cSCC) is a growing health concern with a rapidly increasing incidence. Disease-specific mortality is typically preceded by a metastasis, but current staging systems have significant limitations in predicting this event. The 40-gene expression profile (40-GEP) test is a validated method of further stratifying patients based on the risk of regional or distant metastasis, but limited guidelines exist for incorporating this test into clinical practice. OBJECTIVE:  To review the available literature on the use of gene expression profile (GEP) testing to assess prognosis in cSCC and create consensus statements to guide dermatology clinicians on its use. METHODS:  A comprehensive literature search of PubMed, EMBASE, and Scopus was completed for English-language original research articles on the use of GEP testing to assess cSCC prognosis. A panel of 8 dermatologists with significant expertise in diagnosing and managing cSCC gathered to review the articles and create consensus statements. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria. RESULTS:  The literature search produced 157 articles that met the search criteria. A thorough screening of the studies for relevance to the research question resulted in 21 articles that were distributed to the panelists for review prior to the roundtable discussion. The panel unanimously voted to adopt 7 consensus statements and recommendations, 6 of which were given a strength of "A" and 1 of which was given a strength of "C". CONCLUSION:  The 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. Incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis and thus may improve morbidity and mortality. J Drugs Dermatol. 2023;22(12):54-60.   doi:10.36849/JDD.7691.


Assuntos
Carcinoma de Células Escamosas , Neoplasias Cutâneas , Humanos , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/genética , Carcinoma de Células Escamosas/terapia , Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/genética , Neoplasias Cutâneas/terapia , Prognóstico , Transcriptoma , Consenso
11.
Drugs ; 84(3): 275-284, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38418773

RESUMO

Rosacea, a chronic skin condition affecting millions of people in the USA, leads to significant social and professional stigmatization. Effective management strategies are crucial to alleviate symptoms and improve patients' quality of life. Encapsulated benzoyl peroxide 5% (E-BPO 5%) is a newly FDA-approved topical treatment for rosacea that shows promise in enhancing therapeutic response and minimizing skin irritation. This review aims to assess the role of recently FDA approved E-BPO 5% in the current treatment landscape for rosacea management, as it is not yet included in clinical guidelines that predominantly rely on older approved therapies. The review focuses on randomized controlled trials conducted in English-speaking adults. It evaluates the efficacy, safety, and tolerability of various US Food and Drug Administration (FDA)-approved agents used for rosacea treatment, including E-BPO cream, metronidazole gel, azelaic acid gel and foam, ivermectin cream, minocycline foam, oral doxycycline, brimonidine gel, and oxymetazoline HCl cream. Existing therapies have been effective in reducing papulopustular lesions and erythema associated with rosacea for many years. E-BPO 5% offers a promising addition to the treatment options due to its microencapsulation technology, which prolongs drug delivery time and aims to improve therapeutic response while minimizing skin irritation. Further research is necessary to determine the exact role of E-BPO 5% in the therapeutic landscape for rosacea. However, based on available evidence, E-BPO 5% shows potential as a valuable treatment option for managing inflammatory lesions of rosacea, and it may offer benefits to patients including: rapid onset of action, demonstrated efficacy by Week 2, excellent tolerability, and sustained long-term results for up to 52 weeks of treatment.


Assuntos
Fármacos Dermatológicos , Rosácea , Adulto , Humanos , Peróxido de Benzoíla/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Metronidazol/uso terapêutico , Qualidade de Vida , Rosácea/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
12.
J Dermatolog Treat ; 35(1): 2298878, 2024 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38192024

RESUMO

Background: The recognition of an association between the development of acne vulgaris (AV) and pubertal hormonal changes during adolescence dates back almost 100 years. Since these formative observations, a significant role of circulating hormones in the pathophysiology of AV and other cutaneous disorders has been established.Aims: This review article aims to provide an overview of clinical and preclinical evidence supporting the influences of androgens on the skin and their therapeutic importance in AV pathophysiology.Results: The cutaneous effects of hormones are attributable, to a large extent, to the influence of steroid hormones, particularly androgens, on sebocyte development and sebum production in both sexes. Androgen-mediated excess sebum production is implicated as a necessary early step in AV pathophysiology and is therefore considered an important therapeutic target in AV treatment. Although the local production and/or activity of androgens within the skin is believed to be important in AV pathophysiology, it has received limited therapeutic attention.Conclusions: We have summarized the current evidence in support of the therapeutic benefits of targeted hormonal treatment to decrease androgen-stimulated sebum production for the effective and safe treatment of AV in both male and female patients.


Assuntos
Acne Vulgar , Dermatite , Adolescente , Humanos , Feminino , Masculino , Androgênios/uso terapêutico , Sebo , Pele , Acne Vulgar/tratamento farmacológico
13.
J Dermatolog Treat ; 35(1): 2296855, 2024 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38146664

RESUMO

BACKGROUND: Sebum physiology and its contributions to acne vulgaris (AV) pathophysiology have been long debated. Within the pilosebaceous unit, androgens drive sebocyte production of sebum, comprising mono-, di-, and triglycerides (the latter converted to fatty acids); squalene; cholesterol; cholesterol esters; and wax esters. Upon release to the skin surface, human sebum has important roles in epidermal water retention, antimicrobial defenses, and innate immune responses. AIMS: Alterations in sebum alone and with other pathogenic factors (inflammation, follicular hyperkeratinization, and Cutibacterium acnes [C. acnes] proliferation) contribute to AV pathophysiology. Androgen-driven sebum production, mandatory for AV development, propagates C. acnes proliferation and upregulates inflammatory and comedogenic cascades. RESULTS: Some sebum lipids have comedogenic effects in isolation, and sebum content alterations (including elevations in specific fatty acids) contribute to AV pathogenesis. Regional differences in facial sebum production, coupled with patient characteristics (including sex and age), help exemplify this link between sebum alterations and AV lesion formation. CONCLUSIONS: To date, only combined oral contraceptives and oral spironolactone (both limited to female patients), oral isotretinoin and topical clascoterone (cortexolone 17α-propionate) modulate sebum production in patients with AV. A better understanding of mechanisms underlying sebaceous gland changes driving AV development is needed to expand the AV treatment armamentarium.


Assuntos
Acne Vulgar , Sebo , Humanos , Feminino , Acne Vulgar/tratamento farmacológico , Acne Vulgar/patologia , Glândulas Sebáceas , Pele/patologia , Ácidos Graxos/uso terapêutico
14.
J Drugs Dermatol ; 22(12): 7691, 2023 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-38051842

RESUMO

BACKGROUND: Cutaneous squamous cell carcinoma (cSCC) is a growing health concern with a rapidly increasing incidence. Disease-specific mortality is typically preceded by a metastasis, but current staging systems have significant limitations in predicting this event. The 40-gene expression profile (40-GEP) test is a validated method of further stratifying patients based on the risk of regional or distant metastasis, but limited guidelines exist for incorporating this test into clinical practice. OBJECTIVE: To review the available literature on the use of gene expression profile (GEP) testing to assess prognosis in cSCC and create consensus statements to guide dermatology clinicians on its use. METHODS: A comprehensive literature search of PubMed, EMBASE, and Scopus was completed for English-language original research articles on the use of GEP testing to assess cSCC prognosis. A panel of 8 dermatologists with significant expertise in diagnosing and managing cSCC gathered to review the articles and create consensus statements. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria. RESULTS: The literature search produced 157 articles that met the search criteria. A thorough screening of the studies for relevance to the research question resulted in 21 articles that were distributed to the panelists for review prior to the roundtable discussion. The panel unanimously voted to adopt 7 consensus statements and recommendations, 6 of which were given a strength of "A" and 1 of which was given a strength of "C". CONCLUSION: The 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. Incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis and thus may improve morbidity and mortality. J Drugs Dermatol. 2023;22(12): doi:10.36849/JDD.7691e.


Assuntos
Carcinoma de Células Escamosas , Neoplasias Cutâneas , Humanos , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/genética , Carcinoma de Células Escamosas/terapia , Consenso , Prognóstico , Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/genética , Neoplasias Cutâneas/terapia , Transcriptoma
15.
J Am Acad Dermatol ; 89(5): 927-935, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37656094

RESUMO

BACKGROUND: A three-pronged acne treatment approach-combining an antibiotic, antibacterial agent, and retinoid-may provide greater efficacy than single/double treatments. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (IDP-126) is the first fixed-dose triple-combination in development for acne. OBJECTIVE: To confirm efficacy, safety, and tolerability of IDP-126 gel in acne treatment. METHODS: Two phase 3, double-blind, 12-week studies randomized participants aged ≥9 years with moderate-to-severe acne (N = 183; N = 180) 2:1 to once-daily IDP-126 or vehicle gel. Co-primary endpoints comprised participants achieving ≥2-grade reduction from baseline in Evaluator's Global Severity Score (EGSS) and clear/almost clear skin (treatment success) and change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed. RESULTS: At week 12, 49.6% and 50.5% of participants achieved treatment success with IDP-126 versus 24.9% and 20.5% with vehicle (P < .01, both). IDP-126 also provided significantly greater reductions in inflammatory/noninflammatory lesions versus vehicle (least-squares mean percent range: 72.7% to 80.1% vs 47.6% to 59.6%; P < .001, all). Most TEAEs were of mild-moderate severity. LIMITATIONS: Inter-observer bias/variation in acne severity ratings, limited treatment duration, and population differences that may not generalize to real-world populations. CONCLUSION: The innovative fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in 2 clinical studies of participants with moderate-to-severe acne.

16.
J Clin Aesthet Dermatol ; 16(9): 20-24, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37720199

RESUMO

Objective: Isotretinoin is a widely used and clinically efficacious treatment for severe, recalcitrant, nodular acne vulgaris (AV). Clinicians are generally familiar with safety concerns regarding isotretinoin use, especially teratogenicity. However, there are specific "real-world" challenges with use of conventional formulations based on the original isotretinoin formulation, including poor solubility and food-dependent absorption requiring high fat intake with each dose. This review describes the development and use of new isotretinoin formulations and their potential to improve long-term outcomes in patients with AV. Methods: PubMed was searched using the terms "acne," "isotretinoin," "micronized," "lidose," and "efficacy." Results: Micronized isotretinoin received US Food and Drug Administration approval in 2019 for the treatment of severe recalcitrant nodular acne in patients aged 12 years or older. This isotretinoin formulation utilizes micronization technology to reduce drug particle size, thereby increasing its dissolution rate and bioavailability, combined with a lipid-based carrier system that enhances gastrointestinal absorption without the need for dietary fat ingestion. Together, these features allow for an approximately two-fold or greater increase in isotretinoin absorption despite a lower administered dose compared with prior formulations, without dependency upon high-fat food intake. Limitations: Evidence supporting reduction in relapse with micronized isotretinoin is based on studies with the lidose formulation and pharmacokinetic data supporting greater systemic exposure to micronized isotretinoin without food. Conclusion: The lack of any specific dietary requirements or need for food intake and the enhanced bioavailability of micronized isotretinoin may increase both patient compliance and the rate of prolonged remission of AV after completion of therapy.

17.
J Clin Aesthet Dermatol ; 16(8 Suppl 1): S12-S17, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37636015

RESUMO

Despite its high global prevalence, molluscum contagiosum (MC) is not well understood outside of dermatology. Due to the potential self-limiting nature of MC, a common clinical approach in management is to wait for the papules to resolve spontaneously over several weeks to months, without medical intervention. However, this "watch and wait" approach increases risk of spreading the virus to others, extending the duration of the infection, and emergence of several psychosocial issues (e.g., anxiety, embarrassment, isolation). Molluscum contagiosum can be particularly challenging to treat in immunocompromised patients (e.g., human immunodeficiency virus [HIV], organ transplant recipients). This article reviews diagnostic characteristics and treatment options for MC, as well as associated risk factors and comorbidities. Treatment of immunocompromised individuals, in whom the risks of diffuse MC with persistence and spread are relatively high, is emphasized. The authors highlight the importance of actively treating the MC papules, as opposed to letting the virus "run its course" with no active intervention, with the goals of reducing the risk of spreading infection to others, shortening the duration of infection, and decreasing adverse psychosocial sequelae commonly associated with MC.

18.
J Clin Aesthet Dermatol ; 16(8 Suppl 1): S4-S11, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37636018

RESUMO

Molluscum contagiosum (MC) is a viral infection that affects primarily pediatric patients, sexually active young adults, and immunocompromised people of all ages. MC occurs all over the world, making up about one percent of skin disorders and appears to be increasing in prevalence. This cutaneous infection is often associated with atopic dermatitis and is typically self-limiting, although spontaneous resolution can take months to years. Many treatments exist, but only one-a drug-device product using topical cantharidin- is approved by the United States (US) Food and Drug Administration (FDA) for treatment of MC. For many years, there was a lack of an established or FDA-approved first-line treatment for MC, which might have contributed to the common "benign neglect" attitude of physicians regarding treatment of MC. Unfortunately, this noninterventional approach can increase risk of spreading infection and result in longer duration of infection, physical discomfort, and psychosocial issues due to persistence of the MC lesions. This article reviews available epidemiology data and explores treatment options and therapeutic gaps in MC management.

20.
J Dermatolog Treat ; 34(1): 2147391, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36382987

RESUMO

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 adversos
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