Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis.

OBJECTIVE: The objective of this study was to review the safety and efficacy of deucravacitinib, a tyrosine kinase 2 (TYK2) inhibitor for moderate to severe plaque psoriasis. DATA SOURCES: Literature was reviewed from MEDLINE and Clinicaltrials.gov up to December 2022 using the terms "deucravacitinib" and "BMS-986165." STUDY SELECTION: Relevant articles in English relating to the pharmacodynamics, pharmacokinetics, efficacy, and safety of deucravacitinib were included. A total of 6 trial results were included. STUDY SELECTION AND DATA EXTRACTION: Deucravacitinib showed clinical efficacy across all the phase II and III clinical trials. Excluding the long-term extension study, there were 2248 subjects across all studies, with 63.2% of patients receiving deucravacitinib 6 mg daily. Of these subjects, the average proportion achieving a PASI 75 (a reduction of greater than 75% in the Psoriasis Area and Severity Index) at week 16 was 65.1%. Patients receiving deucravacitinib 6 mg once daily had a higher rate of achieving both PASI 75 response and a Static Physician's Global Assessment (sPGA) score of 0 or 1, compared with oral apremilast 30 mg twice daily. The safety profile of deucravacitinib includes mild adverse events (AEs), most commonly nasopharyngitis, with serious AEs reported ranging from 1.35% to 9.5%. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING MEDICATIONS: While many available therapies for moderate to severe plaque psoriasis rely on an injectable dosage form or extensive monitoring, deucravacitinib can potentially reduce patient medication-related burden. This review summarizes the efficacy and safety of oral deucravacitinib for the treatment of severe plaque psoriasis. CONCLUSION: Deucravacitinib shows a consistent efficacy and safety profile as the first oral TYK2 inhibitor approved for adult patients with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy treatment.

Spesolimab: A Review of the First IL-36 Blocker Approved for Generalized Pustular Psoriasis.

OBJECTIVE: This article reviews clinical trial data that assesses the safety, efficacy, and clinical application of spesolimab, an interleukin-36 (IL-36) blocker, for the treatment of generalized pustular psoriasis (GPP). DATA SOURCES: A review of the literature was conducted using the search terms: "spesolimab," "BI 655130," and "spevigo" in MEDLINE (PubMed) and Clinicaltrials.gov from January 1, 1950 to October 31, 2023. STUDY SELECTION AND DATA EXTRACTION: Relevant articles in English relating to the pharmacodynamics, pharmacokinetics, efficacy, and safety of spesolimab were included. DATA SYNTHESIS: In one phase 2 clinical trial evaluating single dose IV spesolimab for GPP flares at day 8, 54% of patients receiving spesolimab had a GPP physician global assessment (GPPGA) pustulation subscore of 0, and 43% had a GPPGA total score of 0 compared with 6% and 11% for the placebo group, respectively. Another phase 2 clinical trial assessing subcutaneous spesolimab found 23% of patients in low-dose, 29% in medium-dose, and 10% of high-dose spesolimab had flares by week 48 compared with 52% of the placebo group. Hazard ratios for time to GPP flare compared with placebo were 0.16 (P = 0.0005), 0.35 (P = 0.0057), and 0.47 (P = 0.027) for the spesolimab groups, respectively. Infection rates were similar across treatment and placebo groups, and severe adverse events such as drug reactions with eosinophilia and systemic symptom (DRESS), cholelithiasis, and breast cancer occurred with spesolimab. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING DRUGS: Spesolimab is a first-in-class IL-36 monoclonal antibody receptor antagonist approved for the treatment of acute GPP flares. It is a safe and effective therapeutic agent in preventing future GPP flares, with no current comparator trials with other GPP agents. CONCLUSION: Spesolimab is a safe and effective treatment for acute GPP flares in adults. Future clinical trials can establish safety and efficacy compared with other agents.

Role of VivaScope 2500 ex vivo confocal microscopy in skin pathology: Advantages, limitations, and future prospects.

BACKGROUND: Vivascope 2500 ex vivo confocal microscopy (EVCM) is an emerging optical imaging device that allows nuclear level resolution of freshly excised tissues. EVCM provides, rapid real-time pathological examination in many subspecialties of pathology including skin, prostate, breast, liver, etc. In contrast to traditional time-consuming frozen sectioning and histological analysis. AIMS: To evaluate the current state of EVCM utilization. MATERIALS AND METHODS: This study highlights the advantages, limitations, and prospects of EVCM in skin pathology. RESULTS: Our findings demonstrate that EVCM is a promising adjunctive tool to assess margins in Mohs surgery and to provide rapid, accurate diagnosis of cutaneous tumors, infectious and inflammatory diseases. CONCLUSION: EVCM is a revolutionary device that can be used as an adjunct to paraffin-fixed, hematoxylin and eosin-stained slides and frozen sectioning. Additional refinements are required before EVCM can be used as an alternative to frozen sectioning or traditional tissue processing.

A Review of the Efficacy of Topical Statins for Treating Disseminated Superficial Actinic Porokeratosis.

Porokeratosis is a rare group of acquired or hereditary dermatoses characterized by linear or annular plaques with a keratotic border. DSAP is the most common porokeratosis, and lesions range from asymptomatic to pruritic circular pink to brown macules, papules, or plaques surrounded by a raised border. DSAP carries about 7.5-10% risk of malignant transformation to SCC or BCC. While in the past DSAP has been widely treated with topical diclofenac, ingenol mebutate, topical vitamin D analog, 5-fluorouracil, imiquimod, photodynamic therapy, retinoids, cryotherapy, and laser therapy, these therapies have shown limited efficacy and have caused adverse effects including inflammatory reactions, hyperpigmentation, pain, and erythema. Recently, a formulation of topical statin and cholesterol has surfaced as a new and promising treatment for DSAP which has shown clinical improvement with a tolerable adverse effect profile when compared to the current therapies. Of the 8 case studies with a total of 20 patients with DSAP, 90% (18/20) reported clinical improvement with various forms of topical statin therapy. While promising, larger randomized controlled trials are needed to evaluate the long-term use of topical statins for DSAP. J Drugs Dermatol. 2023;22(10):     doi:10.36849/JDD.7540.

In Vivo Reflectance Confocal Microscopy Evaluation of Microneedle Patch Penetration Depth.

BACKGROUND: Firstly, confirm penetration of the skin's most exclusive layer, the stratum corneum (SC), by commercially available microneedle patches using reflectance confocal microscopy (RCM). Secondly, determine the deepest layer of the skin penetrated by the microneedle patches. MATERIALS AND METHODS: In this proof-of-concept study, 3 commercially available dissolving microneedle patches with different active ingredients were included in this study. RCM images of the cheek were taken prior to patch application at 4 different layers of the skin: stratum corneum, stratum spinosum-granulosum, dermal-epidermal junction, and papillary dermis. Patches were then applied to the cheeks of participants according to manufacturer guidelines. Immediately after removal, the same area and layers were imaged using RCM and assessed for features of penetration. RESULTS: Micropores were visualized in RCM images of skin layers post-application of all patches when compared with imaging before application. Characteristics of penetration included uniformly sized, shaped, and spaced well-defined circular areas, which are the created micropores. All 3 patches penetrated the SC to the level of the papillary dermis. CONCLUSION: This study confirms that the dissolving microneedle patches penetrate the most exclusive layer of the skin, the SC, down to the level of the papillary dermis as visualized through RCM. Confirming penetration with RCM shows the potential of these patches to be used for medication transmission. While future studies are needed to assess the efficacy of microneedle patches applied for their advertised skin conditions, confirming the penetration of the microneedle technology through RCM is a significant first step in this process. J Drugs Dermatol. 2023;22(11):1107-1110     doi:10.36849/JDD.6994.

Comparing the Efficacy for Pulse Versus Continuous Dose Terbinafine Therapy in Patients With Onychomycosis.

Recently, treatment outcomes in patients with toenail onychomycosis have improved considerably due to more effective oral antifungal medications such as terbinafine and itraconazole. These medications can either be used continuously for several weeks at a lower dose or intermittently (pulsed) at a higher dose. Previous literature comparing pulse and continuous therapy has generated mixed results.  Our study aims to compare the efficacy, in terms of clinical cure rate, of continuous vs pulse dose terbinafine regimens for toenail onychomycosis. Sixty patients with onychomycosis of Fitzpatrick skin types IV to VI, between 15 and 65 years of age, were divided into a continuous treatment group receiving 250 mg terbinafine once daily for 12 weeks and a pulse treatment group receiving 250 mg twice daily terbinafine for 1 week repeated every 4 weeks for 12 weeks. Each patient was followed up at weeks 4, 8, and 12.  Efficacy of the continuous treatment group was significantly greater at 76.67% compared with 26.67% in the pulse treatment group. Thus, we conclude that the clinical cure rate of a continuous dose regimen of terbinafine is a superior treatment option for toenail onychomycosis. However, we also suggest further studies including combinations of multiple agents and hybrid regimen models for the optimal onychomycosis treatment.   J Drugs Dermatol. 2023;22(10):     doi:10.36849/JDD.7323R1.

Clinical Efficacy of Topical Vitamin C on the Appearance of Wrinkles: A Systematic Literature Review.

PURPOSE: A rise in market demand for anti-aging skin care products has resulted in a proliferation of cosmeceuticals, including products that contain vitamin C. Many topicals containing vitamin C claim to reduce the appearance of wrinkles. However, these claims have not been systematically evaluated. METHODS: A systematic review of literature published between January 2015 and September 2022 was performed per PRISMA guidelines. Scopus, Web of Science, and PubMed were queried for records relevant using the following Medical Subject Heading (MeSH) terms: “Topical Vitamin C OR Ascorbic acid”, “Vitamin C efficacy”, “dermatology”, “cosmetology”, and “skin anti-aging”. Variables of interest included: study type, study location, study duration, sample size, patient description, type and ingredients of the topical formulation, outcome measurement, results, and adverse events. RESULTS: After deduplication, consideration of inclusion and exclusion criteria, and title/abstract screening, 5,428 initial records were reduced to 7 articles, including 4 meeting Level IB criteria, one meeting Level IIA criteria, and 2 meeting Level IIB criteria. Methods for assessing clinical improvements included global photodamage score, skin topography assessment, reflectance confocal microscopy (RCM) skin analysis, Dynamical Atlas, and participant self-assessment.  Conclusions: While 4 of the 7 studies met Level IB evidence, further high-quality, prospective, and comparative studies are indicated to better elucidate the role of topical vitamin C in wrinkle reduction. All the studies used vitamin C in combination with other ingredients or therapeutic mechanisms, thereby complicating any specific conclusions regarding the efficacy of vitamin C. Citation: Sanabria B, Berger LE, Mohd H, et al. Clinical efficacy of topical vitamin C on the appearance of wrinkles: a systematic literature review. J Drugs Dermatol. 2023;22(9):898-904. doi:10.36849/JDD.7332.

Multicentric reticulohistiocytosis with dermatomyositis-like features: A case report with dermoscopy and reflectance confocal microscopy findings.

Multicentric reticulohistiocytosis (MRH) is an insidious-onset, non-Langerhans-cell histiocytosis (NLCH) affecting the joints and skin. Early diagnosis is important to prevent destructive arthritis and disease-related complications. Reflectance confocal microscopy (RCM) is a technique that allows the visualization of the epidermis and superficial dermis noninvasively on a horizontal plane with quasi-histologic images of the skin. RCM features of NLCH including Rosai-Dorfman disease, adult xanthogranuloma (AXG), and juvenile xanthogranuloma (JXG) have been reported. However, RCM features of MRH have not been described previously. Here we present the RCM features of a case of MRH with dermoscopic and histopathologic features.

A case of dermatofibrosarcoma protuberans and reflectance confocal microscopy of a post-surgical skin graft.

Dermatofibrosarcoma protuberans (DFSP) is an overall rare malignancy yet is one of the most common cutaneous sarcomas. The diagnosis of DFSP is typically made following histopathologic examination of the lesion, classically revealing a storiform pattern of spindle cells with elongated nuclei infiltrating the dermis and subcutis. Surgical excision is the standard treatment. Local recurrence is estimated to occur in 20-50% of cases, thus frequent postsurgical monitoring is required. Noninvasive imaging modalities offer a potential alternative to multiple repeat biopsies. We report the first case where reflectance confocal microscopy accompanied clinical examination in monitoring for DFSP recurrence postsurgical excision.

Reflectance confocal microscopy evaluation of pigmented lesions on tattooed skin.

The evaluation of pigmented lesions on tattooed skin poses a diagnostic challenge for dermatologists, as a nevus may be partially or completely obscured by tattoo pigment. Because of incidences of melanoma arising from tattooed skin, the current gold standard is to biopsy these lesions. Reflectance confocal microscopy (RCM) is a noninvasive imaging modality used in the diagnosis and management of skin diseases that may allow for diagnosis, while preserving the tattoo design. Retrospective chart review was conducted to identify pigmented lesions on or near tattooed skin that were evaluated with RCM. Confocal characteristics and diagnoses were recorded and analyzed. Nineteen lesions from 15 patients were retrospectively reviewed. Tattoo pigment did not hinder evaluation and diagnosis of pigmented lesions on RCM. About 94.7% of lesions were diagnosed as benign melanocytic nevi by an expert confocal reader. One lesion was confocally diagnosed as melanocytic nevus with atypia but was found to be an inflamed melanocytic nevus on histology. Tattoo pigment particles were differentiated from other hyper-refractile entities by an expert confocal reader based on size, morphology, and clinical correlation. RCM may provide a solution to the diagnostic challenge of pigmented lesions on or near tattooed skin.

The growth of teledermatology: Expanding to reach the underserved.

The regulation of telemedicine in the United States is evolving, with new legislation expanding reimbursement and cross-state licensing capabilities. As telemedicine grows, communities with limited access to traditional dermatologic care may find a solution in teledermatology. A search of the medical literature and online health care law resources published within the past decade was performed to assess the current status of telemedicine availability, health record integration and security, reimbursement policy, and licensure requirements in the United States, with a focus on teledermatology. The majority of states have implemented policies requiring private insurance coverage. Medicaid reimburses some form of telemedicine in all states but restricts which modalities can be used and by which specialties. Medicare places the heaviest limitations on telemedicine coverage. Twenty-four states and Guam are members of the Interstate Medical Licensure Compact (IMLC), and 27 states offer alternative cross-state practice options. With the advent of publicly and privately funded programs, volunteer efforts, and mobile applications, teledermatology is more readily available to rural and underserved communities.

Life of a Wound: Serial Documentation of Wound Healing After Shave Removal Using Reflectance Confocal Microscopy

Reflectance Confocal Microscopy (RCM) is a new noninvasive skin imaging modality that is comparable to traditional histopathology. We present serial in vivo RCM imaging of an atypical nevus after shave excision over a 1-month period. Findings on RCM images are consistent with the inflammatory, proliferative, and remodeling phases of wound healing, and RCM may serve as a new tool to study wound healing in vivo over time. J Drugs Dermatol. 2019;18(5):472-474.

Use of Biologics in Private Practice: Nine Years of Lessons and Learning.

Over a decade ago, the FDA approved biologics for psoriasis, which changed how the disease is treated and, in most cases, has a significant positive impact on the lives of patients. Side effects primarily identified during the investigational and research phase led to the development of specific guidelines for treatment. The treatment guidelines have been amended to incorporate better understandings of side-effects over the years that the disease has been treated. In this study, we focused on a chart review that included assessing the current guidelines and their alignment with modern patient management and the recent side effects presented. This life-cycle evaluation included over 100 patients, management of their treatment, laboratory abnormalities, criteria for choosing or changing to a different biologic, and the effects of the treatments management throughout the years. The review identified some recommended changes in the application and treatment of psoriasis with biologics. To further evidence our findings, we hope to expand this study to a larger scale with more patients.

J Drugs Dermatol. 2017;16(3):215-217.