OBJECTIVE:To investigate whether oral ivermectin or topical 5% permethrin can clinically cure scabies in index cases and in members of their households. DESIGN:Multicentre, assessor blinded, cluster randomised clinical trial. SETTING:28 French hospitals, 19 January 2016 to 16 December 2021. PARTICIPANTS:Index cases; adults and children weighing >15 kg with scabies, confirmed by dermoscopy. INTERVENTIONS:Index cases were randomly assigned to the ivermectin group or permethrin group (1:1 ratio). Each member of the cluster, defined as the household of each index case, received the same treatment as the index case, except for children weighing <15 kg who were prescribed topical 5% permethrin. All participants received oral ivermectin 200 µg/kg or 5% permethrin cream on day 0 and day 10. Permethrin cream was applied to the whole body, from head to toe. MAIN OUTCOME MEASURES:The primary outcome was clinical cure of the cluster on day 28 (ie, disappearance of clinical signs and symptoms of scabies for all cluster members). Secondary outcomes were index case and individual level analyses and safety. Dermatologists were used as assessors and were masked to the treatment. RESULTS:507 participants in 142 households (clusters) were treated with ivermectin and 568 participants in 147 households received permethrin. Cluster level cure rates were 71.8% versus 88.5% (-16.7 percentage point difference, 95% confidence interval (CI) -26.3 to -7.1) for ivermectin versus permethrin. Secondary outcome percentage point differences also showed the inferiority of ivermectin compared with 5% permethrin for index cases (76.6% v 91.5%; percentage point difference -14.9, 95% CI -23.6 to -6.2) and participants (85.3% v 94.2%; -9.2 percentage point difference, -14.9 to -3.5). Intraclass correlation coefficients were higher for permethrin than ivermectin for all clusters (0.68, 95% CI 0.61 to 0.75 v 0.46, 0.37 to 0.56) and for cluster size >1 (0.67, 0.60 to 0.74 v 0.47, 0.37 to 0.56). Cutaneous adverse events were found in 11.9% and 15.6% of participants treated with ivermectin and permethrin, respectively. CONCLUSIONS:The results of this cluster randomised trial of classic scabies, confirmed by dermoscopy, did not show the non-inferiority of oral ivermectin compared with 5% permethrin cream, given on days 0 and 10, in achieving clinical cure of scabies on day 28 in index cases and their household members. Conversely, the trial showed the statistical superiority of 5% permethrin cream. TRIAL REGISTRATION:NCT02407782.
BACKGROUND:Fixed drug eruption (FDE) is a common cutaneous adverse reaction characterized by recurrent, well-demarcated lesions appearing at the same site upon re-exposure to a causative drug. Genital involvement represents one of the most frequent mucosal localizations in men but remains poorly described in the literature, often leading to diagnostic confusion with sexually transmitted infections. We aimed to systematically review the epidemiological, clinical and etiological characteristics of male genital FDE. METHODS:A systematic review was conducted according to PRISMA 2020 guidelines. Medline, Google Scholar, Embase and the Cochrane Library were searched for articles published between 1970 and 2024, using predefined keywords relating to FDE and male genital involvement. Eligible publications included case reports and case series describing genital FDE in adult male patients. Data on demographics, clinical presentation, drug triggers, diagnostic methods and extragenital involvement were extracted. Weighted medians and means were calculated when applicable. RESULTS:Seventy studies were included, encompassing 262 male patients. The weighted median age was 35.5 years. Genital lesions were most commonly located on the glans penis (72.9%), followed by the shaft (17.6%), foreskin (12.2%), and scrotum (4.2%). Erythema (85.9%) was the predominant clinical presentation, while erosions (36.3%), bullae (26.7%), and post-inflammatory pigmentation (26.2%) were variably reported. In 79% of cases, genital involvement was isolated. Among extragenital sites, the oral mucosa was most frequently affected (54.5%). A causative agent was identified in 93.1% of patients. The most commonly implicated drugs were trimethoprim-sulfamethoxazole (27.9%), cyclines (20.9%), and NSAIDs (12.3%). The weighted median time to onset was 48 hours. Diagnosis relied solely on clinical history in 56.1% of patients, with oral provocation tests most frequently used when further allergy workup was performed. CONCLUSION:This review represents the largest synthesis of male genital FDE to date. The condition predominantly affects the glans and is most commonly induced by antibiotics and NSAIDs. Recognizing its characteristic presentation and drug associations is essential to differentiate it from sexually transmitted infections and avoid recurrent episodes.
We report the first documented case of adult-onset Multiple Minute Digitate Keratoses (MMDK) localized exclusively to the penile shaft. Dermoscopic and histopathological examination revealed distinctive features that assisted in excluding other keratinization disorders. This unusual presentation expands the clinical spectrum of MMDK and highlights the importance of careful clinicopathological correlation in genital keratoses.
Lichen aureus is a pigmented purpuric dermatosis typically localized to the lower extremities. In contrast, penile involvement is unusual, with only two pediatric cases previously reported. We report here the first two adult cases with lesions located on the penis.
Background: Diagnosing red legs on first presentation is challenging. There exists a lack of robustly developed and validated diagnostic red leg tools in clinical practice. Physicians fear missing cases of infectious red legs and treat many patients unnecessarily with antibiotics. Objective: Develop and validate easy-to-use diagnostic tools applicable at bedside of patients to orient diagnosis of the commonest and most serious causes of infectious red legs (non-necrotizing bacterial dermohypodermitis (NNBDH), and necrotizing fasciitis (NF)) versus the commonest inflammatory cause (eczema). Methods: We collected data of patients presenting to our dermatology department from January first 2012 until May 17th 2017 with a diagnosis of red leg. Three models were developed using fast frugal trees. Validation was performed in a second cohort of patients. Results: A total of 187 patients (mean age 56, SD = 21 years, 48.1% women) were included in the development phase and 62 patients (mean age 64, SD = 19, 52% women) in the validation phase. In the validation data set, sensitivity and specificity were respectively 67% and 91% for NNBDH, 83% and 66%, for NF and 88% and 93%, for eczema. Conclusion: Presentations of suspected lower-limb infections are commonly misdiagnosed, resulting in avoidable antibiotic prescription and hospitalization. We developed an easy-to-use clinical diagnostic tool applicable at the bedside of patients to help orient physicians in certain situations and avoid unnecessary initiation of antibiotics. Future work should focus on validating this tool in primary care to minimize misdiagnosis of red legs and overprescription of antibiotics.
Atopic dermatitis (AD), a prevalent chronic inflammatory skin condition, presents with diverse phenotypes and endotypes. Traditional treatments have included topical corticosteroids, phototherapy, calcineurin inhibitors, and systemic immunosuppressants, the latter often necessitating frequent lab monitoring due to concerns about adverse effects. Recently, the AD treatment landscape has evolved significantly, marked by the introduction of innovative therapies. This advancement is driven by the identification of biomarkers predictive of therapeutic responses and the integration of bench research, leading to improved disease stratification and treatment selection. Emerging therapies, particularly monoclonal antibodies and targeted treatments, have shown exceptional efficacy in managing moderate-to-severe AD. This chapter focuses on clinical trials evaluating the effectiveness of these novel biologic agents other than JAK inhibitors.