RESUMEN
Oral isotretinoin remains a mainstay of treatment for severe, recalcitrant nodular acne. Novel formulations of isotretinoin have been developed over the past decade, including lidose isotretinoin and micronized isotretinoin. It is important to understand the differences between isotretinoin formulations to help guide clinical decision-making and selection of isotretinoin therapy. This study aims to provide evidence-based consensus statements regarding the use of novel formulations of isotretinoin for the treatment of moderate-to-severe acne. The Expert Consensus Group consisted of dermatologists with expertise in the treatment of acne. Voting members met in person to conduct a modified Delphi process; a maximum of 2 rounds of voting were conducted for each consensus statement. A total of 5 statements were generated regarding the use of novel formulations of isotretinoin, addressing the efficacy, tolerability, and side effects of novel isotretinoin formulations. All 5 statements achieved agreement with high consensus. The Expert Consensus Group agrees that individualized selection of isotretinoin therapy is important to maximize efficacy and minimize side effects. Compared to generic isotretinoin, micronized isotretinoin may require lower doses to achieve sufficient plasma concentrations. With the increased bioavailability of micronized formulation, there is no need to calculate cumulative dose; instead, the general recommendation with micronized isotretinoin is to treat for at least 5 months, or longer if needed to achieve clearance. Micronized isotretinoin can be taken in the fed or fasted state and has an acceptable safety profile. J Drugs Dermatol. 2024;23(6):429-432. doi:10.36849/JDD.7971.
Asunto(s)
Acné Vulgar , Consenso , Técnica Delphi , Fármacos Dermatológicos , Isotretinoína , Isotretinoína/administración & dosificación , Isotretinoína/efectos adversos , Isotretinoína/farmacocinética , Humanos , Acné Vulgar/tratamiento farmacológico , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/efectos adversos , Fármacos Dermatológicos/farmacocinética , Administración Oral , Composición de Medicamentos/normasRESUMEN
BACKGROUND: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the first fixed-dose triple-combination approved for the treatment of acne. This post hoc analysis investigated the efficacy and safety of CAB in pediatric (<18 years) and adult (greater than or equal to 18 years) participants. METHODS: In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants greater than or equal to 9 years of age with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed for pediatric and adult subpopulations. Assessments included treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear], inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. RESULTS: At week 12, treatment success rates for both pediatric and adult participants were significantly greater with CAB (52.7%; 45.9%) than with vehicle (24.0%; 23.5%; P<0.01, both). CAB-treated participants in both subgroups experienced greater reductions from baseline versus vehicle in inflammatory (pediatric: 78.6% vs 50.4%; adult: 76.6% vs 62.8%; P<0.001, both) and noninflammatory lesions (pediatric: 73.8% vs 41.1%; adult: 70.7% vs 52.2%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than with a vehicle. Most TEAEs were of mild-to-moderate severity; no age-related trends for safety/tolerability were observed. Conclusions: CAB gel demonstrated comparable efficacy, quality of life improvements, and safety in pediatric and adult participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment option for patients with acne. J Drugs Dermatol. 2024;23(6):394-402. doi:10.36849/JDD.8357.
Asunto(s)
Acné Vulgar , Peróxido de Benzoílo , Clindamicina , Fármacos Dermatológicos , Combinación de Medicamentos , Geles , Calidad de Vida , Humanos , Acné Vulgar/tratamiento farmacológico , Clindamicina/administración & dosificación , Clindamicina/efectos adversos , Clindamicina/análogos & derivados , Niño , Método Doble Ciego , Adolescente , Femenino , Masculino , Adulto , Peróxido de Benzoílo/administración & dosificación , Peróxido de Benzoílo/efectos adversos , Resultado del Tratamiento , Adulto Joven , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/efectos adversos , Administración Cutánea , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: A once-daily, three-pronged approach using an antibiotic, antibacterial, and retinoid may provide faster acne improvement versus monotherapy or dual-combination products. This post hoc analysis compared threshold acne lesion reductions with clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the first FDA-approved triple-combination topical acne product—to its dyads and vehicle. METHODS: Phase 2 (N=741; NCT03170388) and phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies randomized participants aged ≥9 years with moderate-to-severe acne to once-daily CAB or vehicle gel; the phase 2 study included three additional dyad gel arms. The pooled percentage of participants achieving ≥33%, ≥50%, and ≥75% reduction in inflammatory and noninflammatory acne lesions was evaluated. RESULTS: As early as week 4 in the phase 2 study, ≥33% reduction in inflammatory lesions occurred in a significantly greater percentage of CAB gel-treated participants (82.7%) than with the 3 dyads and vehicle (61.1-69.8%; P<0.05, all). These early reductions were sustained throughout the study, with significantly (P<0.05) more CAB-treated participants achieving ≥50% reduction in inflammatory lesions versus dyads and vehicle from weeks 4-12. By week 12, CAB led to substantial reductions of ≥75% in significantly more participants than dyads and vehicle (65.8% vs 49.9-51.2% and 21.6%; P<0.05, all). Similar trends were observed for noninflammatory lesions in the phase 2 study and for inflammatory and noninflammatory lesions in the phase 3 studies. CONCLUSIONS: Lesion count reductions were significantly greater with CAB versus its dyads and vehicle gel as early as week 4, with substantial reductions observed after 12 weeks of treatment. This faster-acting and sustained efficacy of CAB gel—coupled with its optimized formulation, once-daily dosing, and tolerability—may positively impact treatment adherence. J Drugs Dermatol. 2024;23(3): doi:10.36849/JDD.7907.
Asunto(s)
Acné Vulgar , Combinación Adapaleno y Peróxido de Benzoílo , Clindamicina , Humanos , Acné Vulgar/diagnóstico , Acné Vulgar/tratamiento farmacológico , Antibacterianos/administración & dosificación , Clindamicina/administración & dosificación , NiñoRESUMEN
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.
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Fármacos Dermatológicos , Rosácea , Adulto , Humanos , Peróxido de Benzoílo/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Metronidazol/uso terapéutico , Calidad de Vida , Rosácea/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment. METHODS: Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses. Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8. CONCLUSION: A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49. doi:10.36849/JDD.7927.
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Acné Vulgar , Fármacos Dermatológicos , Humanos , Combinación de Medicamentos , Acné Vulgar/diagnóstico , Acné Vulgar/tratamiento farmacológico , Acné Vulgar/inducido químicamente , Peróxido de Benzoílo , Adapaleno , Tretinoina/uso terapéutico , Resultado del Tratamiento , Geles/uso terapéuticoRESUMEN
BACKGROUND: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years or older with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported. METHODS: In the pivotal trials, patients with moderate-to-severe acne vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months. Efficacy was assessed from treatment success based on Investigator's Global Assessment scores (IGA 0/1) in patients aged 12 years or older in the intention-to-treat population; lesion counts were assessed through week 12. Missing data were handled using multiple imputation in the pivotal studies and were not imputed in the LTE study. RESULTS: Of 1421 patients enrolled, 1143 (clascoterone, 576; vehicle, 567) completed week 12; 600 entered and 343 completed the LTE study. The treatment success rate and most lesion count reductions following clascoterone vs placebo treatment reached statistical significance at week 12; the overall treatment success rate increased to 30.2% for facial acne after 12 months and 31.7% for truncal acne after 9 months of treatment. CONCLUSIONS: The efficacy of clascoterone cream 1% for the treatment of acne vulgaris continued to increase over time for up to 12 months in patients aged 12 years or older with acne vulgaris. J Drugs Dermatol. 2024;23(1):1278-1283. doi:10.36849/JDD.7719.
Asunto(s)
Acné Vulgar , Procedimientos de Cirugía Plástica , Propionatos , Humanos , Acné Vulgar/diagnóstico , Acné Vulgar/tratamiento farmacológico , Cortodoxona , EmolientesRESUMEN
BACKGROUND: Acne has psychosocial effects on patient's quality of life (QoL). This post hoc exploratory analysis of pooled phase 3 data assessed the impact of investigational IDP-126 gel (for moderate to severe acne) on the Acne-Specific Quality of Life Questionnaire (Acne-QoL; exploratory endpoint in the trials). Methods: A post hoc exploratory analysis using pooled data (N=309; age ≥13 years) was conducted to assess if 1) changes from baseline to week 12 in Acne-QoL domain scores significantly differ by treatment; 2) differences were clinically meaningful, and 3) relative importance of acne severity as measured by the Evaluator's Global Severity Score (EGSS) or lesion counts explains the changes in QoL (Acne-QoL). Results: Acne-QoL domain scores significantly (P<0.001, each) improved for patients treated with IDP-126 Gel vs vehicle in all four domains (role-emotional [least squares mean difference {LSMean} 4.1], self-perception [LSMean 3.8], acne symptoms [LSMean 2.6], and role-social [LSMean 2.0]). The proportion of responders was significantly higher (P<0.05, each) in the IDP-126 Gel group vs vehicle across Acne-QoL domains, self-perception (odds ratio [OR]: 4.32), acne symptoms (OR: 3.90), role-social (OR: 3.59), and role-emotional (OR: 2.50). Across all Acne QoL domains, the improvement on the EGSS endpoint (53.8-63.3%) was more likely to influence QoL improvements than the inflammatory (20.1-33.4%) and non-inflammatory lesion (9.5-18.7%) counts. Conclusions: This post hoc exploratory analysis of pooled phase 3 data (moderate to severe acne) suggests that treatment with IDP 126 Gel led to statistically significant and clinically meaningful improvements in QoL and improvement in QoL was primarily influenced by EGSS.J Drugs Dermatol. 2023;22(10):1033-1039 doi:10.36849/JDD.7812.
Asunto(s)
Acné Vulgar , Geles , Adolescente , Humanos , Acné Vulgar/diagnóstico , Acné Vulgar/tratamiento farmacológico , Acné Vulgar/patología , Calidad de Vida , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Ensayos Clínicos Fase III como AsuntoRESUMEN
Topical treatments remain the foundation of psoriasis management. Tapinarof (VTAMA®; Dermavant Sciences, Inc.) is a first-in-class, non-steroidal, topical, aryl hydrocarbon receptor (AhR) agonist approved by the US Food and Drug Administration for the treatment of plaque psoriasis in adults and is under investigation for the treatment of psoriasis in children, and atopic dermatitis in adults and children down to 2 years old. Here, we review the mechanism of action of tapinarof and the PSOARING phase 3 trial program in mild to severe psoriasis. AhR is a ligand-dependent transcription factor involved in maintaining skin homeostasis. Tapinarof specifically binds to AhR to decrease proinflammatory cytokines, decrease oxidative stress, and promote skin barrier normalization. In two identical, randomized, 12-week pivotal phase 3 trials, PSOARING 1 and 2, tapinarof cream 1% once daily (QD) demonstrated significant efficacy versus vehicle and was well tolerated in adults with mild to severe psoriasis. In the PSOARING 3 long-term extension trial of repeated, intermittent tapinarof cream in eligible patients completing the pivotal trials, a high rate of complete disease clearance (40.9%) and a remittive effect of approximately 4 months off therapy were demonstrated over 52 weeks, with no tachyphylaxis. The most common adverse event, folliculitis, was mostly mild or moderate and resulted in a low trial discontinuation rate in PSOARING 1 and 2 (≤1.8%). Tapinarof cream 1% QD provides a novel, non-steroidal, topical treatment option for patients with psoriasis and is highly effective and well tolerated with long-term use including when applied to sensitive and intertriginous skin. Bobonich M, Gorelick J, Aldredge L, et al. Tapinarof, a novel, first-in-class, topical therapeutic aryl hydrocarbon receptor agonist for the management of psoriasis. J Drugs Dermatol. 2023;22(8):779-784. doi:10.36849/JDD.7317.
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Dermatitis Atópica , Psoriasis , Humanos , Dermatitis Atópica/tratamiento farmacológico , Emolientes/uso terapéutico , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Psoriasis/metabolismo , Receptores de Hidrocarburo de Aril/agonistas , Piel/metabolismo , Resultado del Tratamiento , Ensayos Clínicos Fase III como Asunto , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Psoriasis is a chronic immune-mediated dermatologic disorder with multisystemic comorbidities, which is effectively treated with a range of prescription therapies. Studies have reported epidermal barrier abnormalities in the lesional skin of psoriasis patients; however, there is currently insufficient information about skin barrier function in psoriasis patients. This review discusses the potential role of gentle cleansers and moisturizers in the management of psoriasis and in promoting a healthy skin barrier. METHODS: A literature review was followed by the authors' discussions and agreement on 5 statements to provide expert guidance for gentle cleansers and moisturizer use in psoriasis patients. RESULTS: In a workshop, the authors provided feedback on 15 draft statements created prior to the meeting, and agreed upon 5 statements. The authors agreed that guidelines rarely mention skincare for psoriasis patients, demonstrating a potential knowledge gap. Skincare may play a role in managing psoriasis as an adjuvant treatment of acute psoriasis and for maintenance treatment of healing skin during asymptomatic periods. Studies of patients with psoriasis applying topical moisturizers (such as those containing salicylic acid or ceramides) showed softened plaques, enhancing the absorption of topical treatments such as corticosteroids. Studies applying ceramide-containing skincare showed an overall improvement in the appearance of the skin and provided relief for psoriasis. CONCLUSION: The authors agreed that skincare and barrier restoration in treating psoriasis is a relatively new concept for most dermatologists. There is a need to develop a more robust body of evidence on skincare for psoriasis to influence clinical practice in a meaningful way. Kircik L, Alexis AF, Andriessen A, et al. Psoriasis and skin barrier dysfunction: the role of gentle cleansers and moisturizers in treating psoriasis. J Drugs Dermatol. 2023;22(8):773-778. doi:10.36849/JDD.7411.
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Psoriasis , Enfermedades de la Piel , Humanos , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Piel , Cuidados de la Piel , Ácido Salicílico/uso terapéuticoRESUMEN
This article aims to provide consensus statements on the use of corticosteroid-containing topical medications for the management of psoriasis. This Psoriasis Expert Group (PEG) includes dermatologist voting members with expertise in psoriasis who convened and evaluated the use of topical medications and previously published guidelines. A modified Delphi process was conducted to reach consensus results. Two rounds of voting were conducted for each topic and panel consensus was determined. Nine statements were developed regarding topical medication efficacy, patient quality of life, frequency of application, medication "feel", and safety and tolerability. Dermatologist experts voted on the statements separately. Patients were not polled. All items received agreement: 15 with high consensus and 1 with moderate consensus. For the treatment of psoriasis, the PEG agreed that patients and physicians prefer topical medications that are effective, provide long-lasting results, have a quick onset of action, and "feel good on the skin" with few adverse effects. The developed consensus statements provide guidance on the topical treatment of psoriasis, including combination therapies, such as a vitamin D and topical corticosteroid analog. These recommendations will be continuously reviewed and updated as more evidence continues to emerge. April W. Armstrong AW, Reddy R, Khan S, et al. Consensus statements on the use of corticosteroid-containing topical medications in psoriasis. J Drugs Dermatol. 2023;22(8):736-741. doi:10.36849/JDD.7453.
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Fármacos Dermatológicos , Psoriasis , Humanos , Calidad de Vida , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Psoriasis/inducido químicamente , Corticoesteroides/efectos adversos , Fármacos Dermatológicos/efectos adversos , Vitamina D/uso terapéutico , Glucocorticoides/efectos adversosRESUMEN
BACKGROUND: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented. Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually. Results: Of 600 patients aged ≥ 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end. CONCLUSIONS: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged ≥ 12 years. Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients ≥ 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592.
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Acné Vulgar , Niño , Humanos , Acné Vulgar/diagnóstico , Acné Vulgar/tratamiento farmacológico , Acné Vulgar/etiología , Método Doble Ciego , Emolientes/efectos adversos , Eritema/inducido químicamente , Eritema/diagnóstico , Índice de Severidad de la Enfermedad , Crema para la Piel/efectos adversos , Resultado del Tratamiento , AdolescenteRESUMEN
BACKGROUND: Benzoyl peroxide and tretinoin are commonly prescribed acne treatments. Historically, they have been difficult to combine in a single formulation due to chemical instability, and both medications are potentially irritating. Microencapsulation helps overcome these challenges. OBJECTIVE: Examine efficacy, safety, and tolerability of encapsulated BPO/encapsulated tretinoin (E-BPO/T) cream, 3%/0.1%. METHODS: Subjects ≥9 years old with moderate to severe acne were enrolled in 2 multicenter, double-blind, vehicle-controlled, parallel trials and randomized (2:1) to 12 weeks of once-daily E-BPO/T (n = 571) or vehicle cream (n = 287). RESULTS: E-BPO/T was significantly superior to vehicle in both studies, with more subjects achieving IGA success with E-BPO/T (38.5%/25.4%) versus vehicle (11.5%/14.7%; P < .001/P = .017). The change from baseline in inflammatory lesion count for E-BPO/T was -21.6 versus -14.8 for vehicle (P < .001) in study 1 and -16.2 versus -14.1 (P = .018) in study 2. The changes from baseline in noninflammatory lesions for E-BPO/T were -29.7 versus -19.8 for vehicle (P < .001) and -24.2 and -17.4 (P < .001) in studies 1 and 2, respectively. E-BPO/T was well tolerated in both studies. LIMITATIONS: Long-term data are not available. CONCLUSION: E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne.
Asunto(s)
Acné Vulgar , Fármacos Dermatológicos , Niño , Humanos , Acné Vulgar/tratamiento farmacológico , Acné Vulgar/inducido químicamente , Administración Cutánea , Peróxido de Benzoílo/efectos adversos , Fármacos Dermatológicos/efectos adversos , Método Doble Ciego , Combinación de Medicamentos , Emolientes/efectos adversos , Inmunoglobulina A , Resultado del Tratamiento , TretinoinaRESUMEN
Background: Acne, a commonly treated skin disease, requires patient-centered management due to its varying presentations, chronicity, and impact on health-related quality of life. Despite this, evidence-based clinical guidelines focus primarily on clinical severity of facial acne, omitting important patient- and disease-related factors, including ongoing management. Objectives: To generate recommendations to support patient-centered acne management, which incorporate priority and prognostic factors beyond conventional clinical severity, traditionally defined by grading the appearance and extent of visible lesions. Methods: The Personalizing Acne: Consensus of Experts consisted of 17 dermatologists who used a modified Delphi approach to reach consensus on statements regarding patient- and treatment-related factors pertaining to patient-centered acne management. Consensus was defined as ≥75% voting "agree" or "strongly agree." Results: Recommendations based on factors such as acne sequelae, location of acne, high burden of disease, and individual patient features were generated and incorporated into the Personalized Acne Treatment Tool. Limitations: Recommendations are based on expert opinion, which may differ from patients' perspectives. Regional variations in healthcare systems may not be represented. Conclusions: The Personalizing Acne: Consensus of Experts panel provided practical recommendations to facilitate individualized management of acne, based on patient features, which can be implemented to improve treatment outcomes, adherence, and patient satisfaction.
RESUMEN
BACKGROUND: Tapinarof cream 1% once daily demonstrated significant efficacy versus vehicle and was well tolerated in two 12-week, phase 3 pivotal trials in adults with mild-to-severe plaque psoriasis. OBJECTIVE: To assess long-term, health-related quality of life and patient satisfaction with tapinarof. METHODS: Patients completing the 12-week trials were eligible for 40 weeks of open-label tapinarof based on Physician Global Assessment score in PSOARING 3, with a 4-week follow-up. Dermatology Life Quality Index was assessed at every visit; Patient Satisfaction Questionnaire responses were assessed at week 40 or early termination. RESULTS: Seven hundred sixty-three (91.6%) eligible patients enrolled; 78.5% completed the Patient Satisfaction Questionnaire. DLQI scores improved and were maintained. By week 40, 68.0% of patients had a DLQI of 0 or 1, indicating no impact of psoriasis on health-related quality of life. Most patients strongly agreed or agreed with all Patient Satisfaction Questionnaire questions assessing confidence in tapinarof and satisfaction with efficacy (62.9%-85.8%), application ease and cosmetic elegance (79.9%-96.3%), and preference for tapinarof versus prior psoriasis therapies (55.3%-81.7%). LIMITATIONS: Open-label; no control; may not be generalizable to all forms of psoriasis. CONCLUSIONS: Continued and durable improvements in health-related quality of life, high rates of patient satisfaction, and positive perceptions of tapinarof cream were demonstrated.
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Four posters about the novel, fixed-dose calcipotriol and betamethasone dipropionate cream (CAL/BDP cream) based on Poly-Aphron Dispersion (PAD) Technology were presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress 2021 and are summarized here. CAL/BDP cream was compared in two randomized, phase 3 trials to vehicle and active comparator (CAL/BDP gel/topical suspension [TS]) in adults with plaque psoriasis (NCT03802344 and NCT03308799). Pooled data from both trials demonstrated significant greater efficacy in favour of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and mPASI75 compared to CAL/BDP gel/TS. CAL/BDP cream was well tolerated and comparable to CAL/BDP gel/TS with no adverse drug reactions with a frequency >1%. In the NCT03308799 study, CAL/BDP cream demonstrated a substantial improvement in the proportion of participants achieving a minimum 4-point improvement on the peak pruritus numeric rating scale (NRS) score compared with vehicle at Weeks 1, 4 and 8. CAL/BDP cream also improved quality of life (QoL), as assessed through the Dermatology Life Quality Index (DLQI), and the EQ-VAS at Week 8 compared with active comparator. Treatment convenience of CAL/BDP cream, as measured by the Psoriasis Treatment Convenience Scale, was superior to CAL/BDP gel/TS at all studied timepoints, including questions addressing formulation's greasiness and overall treatment satisfaction. Finally, an indirect comparison following the Bucher's method of adjusted indirect comparison and the difference-in-differences method was conducted to compare CAL/BDP cream and CAL/BDP foam, as both therapies have been compared to CAL/BDP gel/TS. Indirect evidence showed that treatment with CAL/BDP cream was associated with a trend for greater QoL improvement than CAL/BDP foam when DLQI improvement was assessed at the recommended treatment duration of 8 weeks for CAL/BDP cream and 4 weeks for CAL/BDP foam. CAL/BDP cream was statistically superior versus CAL/BDP foam in four out of five treatment satisfaction domains.
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Fármacos Dermatológicos , Psoriasis , Venereología , Adulto , Humanos , Betametasona/uso terapéutico , Ensayos Clínicos Fase III como Asunto , Fármacos Dermatológicos/uso terapéutico , Combinación de Medicamentos , Emolientes/uso terapéutico , Psoriasis/tratamiento farmacológico , Psoriasis/complicaciones , Calidad de Vida , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
The Janus kinase-signal transducer and activator of transcription (JAK-STAT) intracellular signaling pathway is implicated in the pathogenesis of a number of inflammatory dermatoses. Clinical trials and other studies have demonstrated the efficacy of JAK inhibitors in the treatment of a variety of dermatologic conditions. Here we review JAK inhibitors currently under investigation for the treatment of alopecia areata, vitiligo, sarcoidosis, necrobiosis lipoidica, granuloma annulare, and systemic lupus erythematosus with a special emphasis on safety and the implications of JAK inhibitors during the novel coronavirus 2019 pandemic.
Asunto(s)
Dermatología , Inhibidores de las Cinasas Janus , Enfermedades de la Piel/tratamiento farmacológico , COVID-19 , Dermatología/tendencias , Humanos , Inhibidores de las Cinasas Janus/uso terapéuticoRESUMEN
The Janus kinase-signal transducer and activator of transcription (JAK-STAT) intracellular signaling pathway is utilized by many proinflammatory molecules to mediate downstream effects and activate gene transcription. Activation of the JAK-STAT pathway contributes to a number of inflammatory dermatoses. Clinical trials and smaller studies have demonstrated the efficacy of JAK inhibitors in the treatment of a variety of dermatologic conditions. Here, we review the use of JAK inhibitors for the treatment of a wide range of dermatologic diseases in a two-part review series.
Asunto(s)
Dermatología , Inhibidores de las Cinasas Janus , Humanos , Janus Quinasa 1 , Inhibidores de las Cinasas Janus/farmacología , Inhibidores de las Cinasas Janus/uso terapéutico , Quinasas Janus , Factores de Transcripción STAT , Transducción de SeñalRESUMEN
Rosacea is one of the most common inflammatory skin diseases in the United States, with a complex pathophysiology. One of the major components of the pathophysiology of rosacea is an abnormal immune detection and response to stimuli. Tetracyclines and their derivatives, including minocycline and doxycycline, have anti-inflammatory properties independent of their antibacterial activity that correlate with certain aspects of the pathophysiology, and these drugs are often used by dermatologists to treat rosacea. Biological actions of tetracyclines correlating with rosacea include anti-inflammatory and antioxidative activities, inhibitory effects on angiogenesis, and proteolysis. The objective of this review is to re-establish the current understanding of tetracyclines and their mechanism of action as they relate to the pathophysiology and treatment of rosacea for clinicians. This includes reviewing the inflammatory aspects of rosacea that correlate with the known nonantibiotic properties of tetracyclines and providing the most up-to-date clinical evidence supporting the use of tetracyclines to treat rosacea. Given the evolving and multifactorial nature of pathophysiology, this review offers clinicians a unified picture that includes research on the links between rosacea pathophysiology and clinical presentation, the nonantibiotic properties of tetracyclines that relate to pathophysiologic pathways in rosacea, and the potential for clinical application of tetracyclines in rosacea therapy.
RESUMEN
BACKGROUND: Truncal acne is common and burdensome for patients; however, there is paucity of evidence and guidance for the management of truncal acne. Currently, clinical practice guidelines provide very little guidance on the assessment or management of truncal acne. OBJECTIVES: To identify unmet needs in truncal acne and make recommendations to address clinical and management gaps using an international consensus. METHODS: The Personalising Acne: Consensus of Experts panel consisted of 13 dermatologists, who used a modified Delphi approach to reach a consensus on statements related to clinically relevant aspects of truncal acne evaluation and management. A consensus was defined as ≥75% of the panelists voting "agree" or "strongly agree." The voting was electronic and blinded. RESULTS: The panel identified gaps and made recommendations related to truncal acne identification, assessment, and grading; the evaluation of the impact on patients; and treatment goals and factors to be considered for its management. LIMITATIONS: The recommendations are based on expert opinion, in the absence of high-quality evidence. CONCLUSIONS: We highlighted addressing not just facial acne but also truncal acne during patient consultations. The recommendations made herein may help facilitate the care of patients who present with truncal acne, with or without facial acne.