Monitoring adherence to vulvar lichen sclerosus treatment - a prospective study.

Background: Vulvar lichen sclerosus treatment consists of topical corticosteroids followed by maintenance therapy. Self-reported adherence to topical corticosteroids in vulvar lichen sclerosus is approximately 66-70.4% and adherence to chronic topical medications is poor.Objective: To measure treatment adherence for vulvar lichen sclerosus.Methods: Adults with vulvar lichen sclerosus who were receiving or who were candidates to receive treatment with topical clobetasol propionate 0.05% ointment twice daily received medication tubes equipped with adherence monitors capturing the time and amount of dose dispensed. After 2 months, monitors were returned, and patients were surveyed regarding their adherence.Results: Ten patients participated for a median (range) of 8.5 (7-11) weeks. Eight (80%) and 7 (70%) caps captured medication timing and dosing events, respectively. Median (interquartile range) adherence was 65% (42-77) and median (interquartile range) medication dispensed per use was 0.15 (0.14 - 0.5) grams. Of the 8 patients using active adherence monitors, 2 did not clinically improve; adherence rates and mean quantity dispensed for these two patients were 31% and 0.13 grams, and 9% and 0.74 grams, respectively.Conclusion: Poor adherence to both twice daily application and prescribed medication quantity occurred frequently. Factors related to self-reported non-adherence included perceived greater efficacy, inconvenience, and time-constraints. Patient adherence to recommended treatment and clinical outcomes are areas for improvement in patients with vulvar lichen sclerosus.

A Review of Topical Sirolimus for the Treatment of Facial Angiofibromas in Tuberous Sclerosis Complex.

OBJECTIVE: This article assesses the efficacy, safety, pharmacology, and clinical applications of topical sirolimus 0.2% gel for the treatment of tuberous sclerosis complex (TSC)-associated facial angiofibromas. DATA SOURCES: A review of the literature was conducted using the Medline (PubMed) and EMBASE databases using the keywords topical sirolimus, rapamycin, Hyftor, and tuberous sclerosis. STUDY SELECTION AND DATA EXTRACTION: Articles written in English and relevant to the topic were included. DATA SYNTHESIS: In the phase 2 trial, the mean improvement factor, a composite measure of improved tumor size and redness, was achieved in all patient groups (P < 0.001) with significant responses among the adult and pediatric subgroups at week 12. There were no serious adverse events recorded. In the phase 3 trial, 60% of participants responded to treatment in the sirolimus group compared with 0% in the placebo group with different response rates between the adult and pediatric subgroups at week 12. Sirolimus gel had no serious adverse events, and dry skin was the most common adverse reaction. Patients who had completed the 12-week trials were then enrolled in a long-term trial; angiofibromas had response rates of 78.2% to 0.2% sirolimus gel. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING DRUGS: Topical sirolimus 0.2% is a first-in-class, newly Food and Drug Administration (FDA)-approved, mammalian target of rapamycin (mTOR) inhibitor that is a promising and safe, noninvasive alternative to surgical procedures for TSC-associated angiofibromas. CONCLUSIONS: Topical sirolimus 0.2% gel is a moderately effective treatment for TSC-associated facial angiofibromas with an adequate safety profile.

A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis.

OBJECTIVE: This article reviews the efficacy and safety of 1% tapinarof cream for plaque psoriasis. DATA SOURCES: A literature search was conducted from August 2022 to February 2023. The terms tapinarof, VTAMA, benvitimod, GSK2894512, DMVT-505, and WBI-1001 were queried in PubMed. ClinicalTrials.gov was searched to identify ongoing or unpublished studies. STUDY SELECTION AND DATA EXTRACTION: All clinical trials written in English and relevant to pharmacology, efficacy, and safety were included. DATA SYNTHESIS: In two 12-week phase III clinical trials, disease severity assessed by a Physician's Global Assessment (PGA) score of clear or almost clear and a 2-point PGA improvement was 35.4% and 40.2% at week 12 in the 2 trials, respectively. In the 40-week, open-label extension trial, the efficacy and safety results were similar: 40.9% of patients achieved a PGA of 0 at least once during the trial, and 58.2% of patients with PGA ≥ 2 achieved PGA 0/1 at least once. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING DRUGS: Tapinarof is a topical aryl hydrocarbon receptor agonist and a first-in-class, potentially promising treatment for plaque psoriasis recently approved by the U.S. Food and Drug Administration. CONCLUSION: Compared with placebo, tapinarof may be an effective and safe topical treatment for mild to severe plaque psoriasis. Head-to-head trials to compare the efficacy and adverse effect profile of tapinarof to other topical treatments are still needed, as are investigation in patients with recent or current use of phototherapy or biologic or nonbiologic systemics. Cost and adherence to treatment may be barriers for treatment efficacy.

Understanding the Medical Dictionary for Regulatory Activities (MedDRA) reporting of herpes simplex virus (HSV) adverse events in atopic dermatitis clinical trials.

Drug efficacy is best evaluated by randomized, controlled, double-blind clinical trials; however, safety is harder to assess. The Medical Dictionary for Regulatory Activities (MedDRA) is used to track and categorize adverse events (AE) during clinical trials. Recent atopic dermatitis (AD) clinical trials were reviewed to illustrate how an understanding of MedDRA may be helpful when evaluating the rates and nature of adverse events related to herpes simplex virus (HSV) infection. All completed AD clinical trials (excluding phase I studies) with results on clinicaltrials.gov (01/01/2018-01/31/2023) were queried in January 2023. MedDRA version, preferred term (PT) for AEs captured as "HSV", PTs for other AEs possibly related to HSV, frequency thresholds for reporting non-serious AEs, and route of treatment were recorded. Of the 46 clinical trials, 17 had PTs for AEs captured as "HSV". Among all studies, 11 different versions of MedDRA were utilized, from versions 10 to 24.1. In all studies, PTs for AEs captured as "HSV" were listed in the Infections and Infestations system organ class (SOC) classification of MedDRA. PTs varied from "herpes simplex", "herpes virus infection", "herpes ophthalmic", "ophthalmic herpes simplex", "nasal herpes", "oral herpes", "herpes dermatitis", "eczema herpeticum", "genital herpes simplex", and "genital herpes." While one clinical trial of dupilumab (NCT03359356) simply reported the PT "oral herpes" as an AE, a clinical trial of DS107 (NCT03817190) reported the PTs "oral herpes", "herpes simplex", and "herpes virus infection" separately. In the DS107 clinical trial, it is unclear if the same adverse event was reported under multiple PTs or if multiple HSV-related AEs occurred. Although the definition of HSV is unchanged from 2018 to 2023 and there are few changes between MedDRA versions, coding for HSV is complex. HSV events can be reported in different ways, which may impact the interpretation of a drug's safety profile.

Concurrent Atopic Dermatitis and Psoriasis Successfully Treated With Dual Biologic Therapy.

Atopic dermatitis (AD) and psoriasis are chronic inflammatory skin conditions with clinical and histopathologic features that often overlap, representing an underlying immunopathological spectrum of disease that can complicate the proper diagnosis and treatment of both conditions. We report the case of a patient with longstanding concurrent, treatment-resistant AD and psoriasis who was successfully treated with dual biologic therapy with dupilumab and guselkumab. Our case highlights the importance of considering coexisting AD and psoriasis in patients with treatment-resistant disease and the utility of dual biologic therapy. We also review an established but rare incidence of overlap between AD and psoriasis and highlight diagnostic challenges and the importance of assessing patients comprehensively. Our case also demonstrates the utility of patch testing and tissue diagnosis in patients with concurrent AD and psoriasis, as well as the importance of considering both diagnostic testing and clinical response in clinical decision-making.

Management of Pediatric Psoriasis: A U.S. Survey Based on Visits from the National Ambulatory Medical Care Survey (NAMCS).

INTRODUCTION: Approximately one-third of psoriasis cases present in the first two decades of life. Many psoriasis treatments are approved by the U.S. Food and Drug Administration (FDA) for adults, including topical agents, systemic non-biologic agents, and systemic biologic agents. Only a handful of psoriasis treatments are FDA approved for children. Given the constantly evolving landscape of pediatric psoriasis management, our aim is to characterize how children with psoriasis are treated in the U.S. METHODS: Data from the 2003-2016 and 2018 National Ambulatory Medical Care Survey (NAMCS) were used to evaluate patient demographics and treatment patterns for visits of children with psoriasis. Visits were stratified by those with a diagnosis of psoriasis and those for children with a diagnosis of psoriasis. Separate analyses for visits of children with a diagnosis of psoriasis were performed, including for sex, race, ethnicity, age, specialty of provider seen, and medications prescribed. RESULTS: Pediatric psoriasis visits accounted for 3.3% of visits with psoriasis from 2003 to 2016 and in 2018; about one-third of those visits were to primary care providers. Children with psoriasis were prescribed a variety of topical and systemic medications, of which the most frequently prescribed treatments were topical tacrolimus, followed by topical clobetasol and topical betamethasone dipropionate or betamethasone valerate. Etanercept was the only biologic prescribed to children. At least 59% of the visits for children with a diagnosis of psoriasis included a topical prescription while at least 5.3% of the visits included a systemic prescription. CONCLUSION: Use of off-label treatments was common for pediatric psoriasis. Most children with psoriasis were treated with topicals, of which tacrolimus, an unapproved treatment, was the most common. The frequent use of tacrolimus could indicate an avoidance of corticosteroids in children.

Could red and near-infrared emitting fabric technology improve the severity of psoriasis, polymorphous light eruption, and alopecia areata?

AIM: Low-level light therapy (LLLT) may offer an adjunctive therapeutic tool for inflammatory skin conditions. This pilot study assessed the efficacy of a red/near-infrared (NIR)-emitting fabric for psoriasis, polymorphous light eruption (PMLE), and alopecia areata (AA). METHODS: Fourteen patients (five with psoriasis, five with PMLE, and four with AA) were instructed to wear a red/NIR-emitting (Lumiton®) garment during the 12-week study. Efficacy was assessed subjectively by patient-reported improvement and objectively by the redness, thickness, and scale of elbow psoriasis plaques, the frequency of PMLE flares, and the Severity of Alopecia Tool (SALT) score. RESULTS: Three patients with psoriasis completed the study while two self-discontinued. The three patients who completed the study noted improvement and two had improvements in lesion redness, thickness, or scale, while one was clinically stable. Three patients with PMLE completed the study, and none had a disease flare during the study period. Three patients with AA completed the study: two reported disease improvement and all three had an improved SALT score. CONCLUSION: Use of a wellness apparel that emits red and NIR light may be associated with improved disease severity in patients with mild elbow psoriasis, PMLE, and limited AA. Limitations of this study include continuation on topical, intralesional, or systemic medications and small sample size.

Recommendations for Cost-Conscious Treatment of Basal Cell Carcinoma.

BACKGROUND: Basal cell carcinoma (BCC) affects 3.3 million Americans annually. Treatment modalities for BCC include many surgical and nonsurgical options. The cost of BCC treatment can pose a substantial burden to patients and the healthcare system. Cost can be an important consideration in BCC treatment planning. OBJECTIVE: We present an approach to the management of BCC when cost reduction is a priority. METHODS: A PubMed literature search identified studies on effectiveness of current BCC therapies. Treatment prices were obtained from the Medicare National Fee Schedule, GoodRx, and pharmaceutical companies. The American Academy of Dermatology's (AAD) guidelines for treating BCC were used to develop recommendations for cost-reductive treatment. RESULTS: The cost of treating a primary superficial BCC < 0.5 cm arising on Area M (cheeks, forehead, scalp, neck, jawline, pretibial surface) was $143 with curettage and electrodesiccation (C&E), $143 with cryosurgery, $210 with standard excision and simple reconstruction (SE), $1221 with Mohs Micrographic Surgery (MMS) and simple reconstruction, $472 with imiquimod, $186 with 5-fluorouracil (5-FU), and $354-$371 for photodynamic therapy (PDT). The cost of treating a primary nodular BCC 1.1-2 cm arising on Area L (trunk and extremities, excluding pretibial surface, hands, feet, nail units and ankles) was $183 with C&E, $183 with cryosurgery, $251 with SE and simple reconstruction, $1163-1351 with MMS and simple reconstruction, $472 with imiquimod, $186 with 5-FU, and $354-$371 for photodynamic therapy (PDT). The cost of treating a giant BCC (BCC > 10 cm with aggressive behavior) was $465-3311 with radiation, $139,560 with vismodegib, $144,452 with sonidegib, ~ $44.5 with cisplatin (medication cost only), and at least $184,836 with cemiplimab-rwlc. CONCLUSIONS: For a primary superficial BCC < 0.5 cm arising on Area M, the cost-conscious algorithm prioritizes C&E or cryosurgery. For a primary nodular BCC 1.1-2 cm arising on Area L, the cost-conscious algorithm prioritizes C&E, cryosurgery, or 5-FU. For a giant BCC, the cost-conscious algorithm identifies superficial radiation therapy as first line.

Oral Tetracycline-Class Drugs in Dermatology: Impact of Food Intake on Absorption and Efficacy.

Tetracycline-class drugs are frequently used in dermatology for their anti-inflammatory properties to treat skin diseases such as acne, rosacea, and hidradenitis suppurativa (HS). The American Academy of Dermatology (AAD) clinical guidelines do not offer guidance regarding the co-administration of food with tetracycline-class drugs. The objectives of this study were to review the available evidence regarding whether taking tetracycline-class drugs with food decreases systemic absorption and is associated with an impact on clinical efficacy. A literature search was conducted using the PubMed database between February to May 2023 using the keywords "tetracycline-class drugs", "pharmacokinetics", "absorption", and "dermatology". Inclusion criteria included articles written in English and relevant to the absorption and efficacy of tetracycline-class drugs. This search yielded 131 articles written between 1977 to 2022, of which 29 met the criteria for review. United States Food and Drug Administration (FDA)-approved prescribing information for oral formulations of tetracycline, doxycycline, minocycline, and sarecycline were reviewed. Systemic absorption of tetracycline decreased when co-administered with food. Systemic absorption of oral doxycycline and minocycline was variable with food co-administration. The impact on bioavailability varied with the drug formulation and dosage. The absorption of oral sarecycline decreased when administered with food. Sarecycline is the only oral antibiotic where population pharmacokinetic studies demonstrated limited or no impact of food intake on clinical efficacy. There are no available data for other tetracycline-class drugs in dermatology. If patients find it more tolerable to take doxycycline, minocycline, and sarecycline with food to avoid gastrointestinal distress, this may merit consideration to encourage patient adherence. Since the impact of food intake on absorption varied with the dosage form of doxycycline and minocycline, consulting the appropriate package insert may give clinicians additional insight into differences in the various formulations.

Improvement of Hailey-Hailey Disease With Topical Cinacalcet, 3%, Ointment.

This case report describes a woman in her 50s with a large, crusted, erythematous plaque on the right chest that was consistent with a Hailey-Hailey disease flare.