BACKGROUND: Oral finasteride and topical minoxidil are the current standard of care for male androgenetic alopecia and a combination of the two treatments can be considered for greater efficacy. Clinical trials of topical finasteride have also yielded promising results, but routine care data are lacking. AIMS: To examine patient-reported outcomes of men with androgenetic alopecia who received topical finasteride admixed with minoxidil compared to the current standard of care (oral finasteride). METHODS: Retrospective, cross-sectional study with data from a German direct-to-consumer teledermatology platform between December 2021 and January 2023. Patient-reported outcomes were collected through voluntary follow-up questionnaires provided after 6 weeks on topical finasteride/minoxidil or oral finasteride treatment. RESULTS: A total of 1545 patients who received topical finasteride/minoxidil treatment were included; 238 (15.4%) participated in the follow-up questionnaire. At week six, 62.2% (148/238) reported positive changes in their hair appearance, and 44.1% (105/238) reported an improvement of self-esteem. Treatment-related adverse events were reported in 11.8% (28/238). Full treatment adherence was observed in 74.4% (177/238). Comparing the topical treatment group to those receiving oral finasteride, lower treatment adherence was reported, along with higher rates of local adverse events; no difference was found in the incidence of sexual adverse events. CONCLUSION: Based on patient-reported outcomes, topical finasteride/minoxidil seems to be effective and well tolerated, but not superior to oral finasteride. Lower treatment adherence for topical usage must be considered when considering treatment options. Additional real-world data are needed to further evaluate the efficacy and safety of topical finasteride/minoxidil.
BACKGROUND: Immune checkpoint inhibition has revolutionized melanoma therapy, but many patients show primary or secondary resistance. Biomarkers are, therefore, urgently required to predict response prior to the initiation of therapy and to monitor disease progression. METHODS: In this prospective study, we analyzed the serum C-C motif chemokine ligand 20 (CCL20) concentration using an enzyme-linked immunosorbent assay. Blood was obtained at baseline before the initiation of immunotherapy with anti-PD-1 monotherapy or Nivolumab and Ipilimumab in advanced melanoma patients (stages III and IV) enrolled at the University Medical Center Hamburg-Eppendorf. The CCL20 levels were correlated with clinico-pathological parameters and disease-related outcomes. RESULTS: An increased C-C motif chemokine ligand 20 (CCL20) concentration (≥0.34 pg/mL) at baseline was associated with a significantly impaired progression-free survival (PFS) in the high-CCL20 group (3 months (95% CI: 2-6 months) vs. 11 months (95% CI: 6-26 months)) (p = 0.0033) and could be identified as an independent negative prognostic factor for PFS in univariate (Hazard Ratio (HR): 1.98, 95% CI 1.25-3.12, p = 0.004) and multivariate (HR: 1.99, 95% CI 1.21-3.29, p = 0.007) Cox regression analysis, which was associated with a higher risk than S100 (HR: 1.74). Moreover, high CCL20 levels were associated with impaired overall survival (median OS not reached for low-CCL20 group, p = 0.042) with an HR of 1.85 (95% CI 1.02-3.37, p = 0.043) in univariate analysis similar to the established prognostic marker S100 (HR: 1.99, 95% CI: 1.02-3.88, p = 0.043). CONCLUSIONS: CCL20 may represent a novel blood-based biomarker for the prediction of resistance to immunotherapy that can be used in combination with established strong clinical predictors (e.g., ECOG performance score) and laboratory markers (e.g., S100) in advanced melanoma patients. Future prospective randomized trials are needed to establish CCL20 as a liquid biopsy-based biomarker in advanced melanoma.
PURPOSE OF REVIEW: The role of Sentinel Lymph Node Biopsy (SLNB) is pivotal in the contemporary staging of cutaneous melanoma. In this review, we examine advanced molecular testing platforms like gene expression profiling (GEP) and immunohistochemistry (IHC) as tools for predicting the prognosis of sentinel lymph nodes. We compare these innovative approaches with traditional staging assessments. Additionally, we delve into the shared genetic and protein markers between GEP and IHC tests and their relevance to melanoma biology, exploring their prognostic and predictive characteristics. Finally, we assess alternative methods to potentially obviate the need for SLNB altogether. RECENT FINDINGS: Progress in adjuvant melanoma therapy has diminished the necessity of Sentinel Lymph Node Biopsy (SLNB) while underscoring the importance of accurately identifying high-risk stage I and II melanoma patients who may benefit from additional anti-tumor interventions. The clinical application of testing through gene expression profiling (GEP) or immunohistochemistry (IHC) is gaining traction, with platforms such as DecisionDx, Merlin Assay (CP-GEP), MelaGenix GEP, and Immunoprint coming into play. Currently, extensive validation studies are in progress to incorporate routine molecular testing into clinical practice. However, due to significant methodological limitations, widespread clinical adoption of tissue-based molecular testing remains elusive at present. SUMMARY: While various tissue-based molecular testing platforms have the potential to stratify the risk of sentinel lymph node positivity (SLNP), most suffer from significant methodological deficiencies, including limited sample size, lack of prospective validation, and limited correlation with established clinicopathological variables. Furthermore, the genes and proteins identified by individual gene expression profiling (GEP) or immunohistochemistry (IHC) tests exhibit minimal overlap, even when considering the most well-established melanoma mutations. However, there is hope that the ongoing prospective trial for the Merlin Assay may safely reduce the necessity for SLNB procedures if successful. Additionally, the MelaGenix GEP and Immunoprint tests could prove valuable in identifying high-risk stage I-II melanoma patients and potentially guiding their selection for adjuvant therapy, thus potentially reducing the need for SLNB. Due to the diverse study designs employed, effective comparisons between GEP or IHC tests are challenging, and to date, there is no study directly comparing the clinical utility of these respective GEP or IHC tests.
Lymphadenopathy , Melanoma , Sentinel Lymph Node , Skin Neoplasms , Humans , Melanoma/pathology , Skin Neoplasms/pathology , Sentinel Lymph Node Biopsy , Sentinel Lymph Node/pathology , Neurofibromin 2 , Neoplasm Staging , Prognosis
BACKGROUND: The treatment of melanoma has been revolutionized by the use of immune checkpoint inhibition (ICI), but many patients do not benefit. Furthermore, immune-related adverse events may occur during therapy. A predictive biomarker is needed to reliably identify patients benefitting. In lung, renal cell and bladder cancer early C-reactive protein (CRP) kinetics were shown to be a predictive biomarker for ICI. OBJECTIVE: Here, we investigate early CRP kinetics as predictive biomarker for ICI in melanoma patients. METHODS: Two independent prospectively collected cohorts were analysed: Cohort 1 (n = 87) with advanced and Cohort 2 (n = 99) with completely resected melanoma. Patients were stratified by in the dynamics of CRP after ICI initiation: A doubling of baseline CRP within 30 days followed by at least a 30% drop within 3 months was classified as a CRP flare. If no doubling of CRP was reported, but a 30% drop within 3 months, patients were classified as CRP responders and all others as CRP non-responders. Analysed factors included clinical characteristics like S100B and LDH. Median follow-up was 1.5 and 1.7 years for Cohorts 1 and 2. RESULTS: In Cohort 1 CRP flare (n = 12), CRP responders (n = 43) and CRP non-responders (n = 32) with a progression-free survival (PFS) of 0.7, 0.6 and 0.2 years (p = 0.017) and an overall survival (OS) of 2.2, 1.5 and 1.0 years (p = 0.014), respectively. Multivariable Cox analysis showed an independent risk reduction of progression for CRP responders by 62% compared to CRP non-responders (p = 0.001). In Cohort 2 CRP flare (n = 13), CRP responders (n = 70) and CRP non-responders (n = 16) the log-rank analysis showed a significant difference between OS and recurrence-free survival (RFS) curves (p = 0.046 and p = 0.049). CONCLUSION: Early CRP kinetics could indicate a response to ICI with improved OS and RFS/PFS. CRP flare and CRP response indicating significantly improved outcomes compared to CRP non-responders.
Objective: The use of direct-to-consumer (DTC) teledermatology platforms has increased, particularly for androgenetic alopecia (AGA). However, little is known about the efficacy and safety of these platforms. This study aimed to investigate the patient-reported treatment outcomes and safety of DTC teledermatology for the finasteride treatment of male AGA. Methods: This retrospective, cross-sectional study used data from a German DTC platform for finasteride treatment between December 2021 and January 2023. Patient-reported outcomes were collected through voluntary follow-up questionnaires provided to the patients six weeks after the first prescription to assess treatment outcomes and safety. Results: Data collection included 2269 patients. Of all patients who answered the follow-up questionnaire (n = 191), 79% (150 out of 191) self-reported positive changes in hair appearance, and 59% (113 out of 191) reported an improvement in self-esteem under treatment. Patients with self-reported positive changes in hair appearance were more likely to report improved self-esteem (P < 0.0001). Treatment-related adverse events occurred in 12% (22 out of 191) of the patients. Full treatment adherence was reported in 87% (167 out of 191) of patients. Conclusion: From the patient's perspective, DTC teledermatology has the potential to improve hair appearance and self-esteem. Our results suggest that it may be an effective and safe treatment option for men with AGA, justifying low-threshold access. However, treatment-related adverse events should be closely monitored during follow-up. Further studies are required to evaluate the long-term effects of the DTC teledermatology treatment. By collecting real-world data, teledermatology platforms could be useful beyond their primary focus and could play an important role in the context of future research.
Purpose: The number of online prescription platforms (OPPs) offering telemedical diagnosis and treatment, including finasteride, for androgenetic alopecia (AA) by using medical questionnaires (MQs) has increased. This type of care delivery differs completely from traditional forms. This study aimed to investigate a potential paradigm shift in AA treatment by measuring the extent of traffic generated by OPPs that exclusively treat AA and furthermore by characterizing sociodemographic features of men undergoing finasteride treatment from an OPP in Germany. Patients and Methods: Examination of three OPPs (Keeps, Shapiro MD, Myspring), offering finasteride treatment via MQ between Q1 2018 and Q1 2022 was performed by using SEMRush, a marketing software platform for traffic analysis. Further data regarding sociodemographic characteristics were collected from Myspring by recruiting men with AA who obtained finasteride prescriptions between March 2021 and January 2022. Results: A high number of unique quarterly visitors was recorded. The number of visitors increased on all platforms (Keeps 846%, Shapiro MD 109%, Myspring 427%). Most patients had accessed the platforms from mobile devices. Further data from Myspring included a total of 2904 men. Of all patients who answered the follow-up questionnaire (n = 177), 33.9% had been referred to the platform by television advertising. Of all respondents, 21.5% reported a monthly net income below 1000 euros. 45.2% of responding patients reported being single, while 15.3% considered themselves homosexual, and 4.5% bisexual. Convenience was the most common reason indicated for using an OPP (79.1%). Conclusion: The tremendous increase in the number of visits to OPPs for AA suggests a paradigm shift in medical care, particularly regarding MQ-based finasteride treatment. Sociodemographic data and reasons for platform use suggest that the shift away from traditional care models may increase in the future. The broad use of these digital health services warrants further investigation, particularly regarding patient safety.
Background: There is a high demand for dermatological care in Germany. As use of teledermatology has increased significantly, this study aimed to investigate the impact of teledermatology on patient care. Methods: This retrospective cross-sectional study used data from a direct-to-consumer teledermatology platform using store-and-forward technology available in Germany between July 2021 and April 2022. Additional patient characteristics were collected using a voluntary follow-up questionnaire, 28 days after teleconsultation. Results: Data of 1,999 enrolled patients were evaluated. Patients had a mean age of 36 years, and 61.2% (1,223/1,999) lived in a rural residence. The most common diagnoses included eczema (36.0%, 701/1,946), fungal diseases (15.4%, 299/1,946), and acne (12.5%, 243/1,946). The follow-up questionnaire was answered by 166 patients (8.3%, 166/1,999). In total, 42.8% (71/166) of patients had undergone no previous medical consultation. The most frequent reason for using teledermatology was the waiting time for a dermatology outpatient appointment (62.0%, 103/166). A total of 62.0% (103/166) participants rated the treatment success as good or very good, while 86.1% (143/166) rated the quality of telemedical care as equal or better to that of an outpatient visit. Conclusion: This study showed that patients often use teledermatology because of functional barriers (waiting times). In this cohort, the diagnoses strongly corresponded to reasons for outpatient presentation. Most patients rated the quality of teledermatology service as at least equivalent to that of outpatient physician visits and reported treatment success. Thus, teledermatology can relieve the burden of outpatient care while providing high benefits from the patient's perspective.
Dermatology , Remote Consultation , Skin Diseases , Telemedicine , Humans , Adult , Skin Diseases/diagnosis , Skin Diseases/therapy , Retrospective Studies , Cross-Sectional Studies , Ambulatory Care , Germany
BACKGROUND AND OBJECTIVES: Skin diseases are a common reason for consultations in pediatric practice. The present study aims to characterize the dermatological requests of resident pediatric specialists using teledermatology in Germany. PATIENTS AND METHODS: This analysis of consultation requests, submitted by pediatricians to a designated pediatric dermatologist via a telemedical consultation system (PädExpert) using the store-and-forward technology, was performed between February 2021 and December 2021. RESULTS: The study analysis included 504 telemedical consultation requests. The mean age of the patients was 6.5 ± 5.0 years with 45.5% of the patients being female. Telemedicine was useful in providing a definite diagnosis in 88.3%. The diagnoses were most frequently assigned to the group of infectious skin diseases (28.8%). Referral to a dermatologist was recommended in 11.5%. The requests were answered on the same day in 63.8% of the cases. CONCLUSIONS: The study data shows the great potential of teledermatology to improve access for children with skin diseases to specialized dermatological care. Another advantage is its function as a triage instrument. Since most cases could be managed by teledermatology only, it is possible to reduce the need for an in-person visit to the dermatologist, thus saving resources.
Dermatology , Skin Diseases , Telemedicine , Humans , Child , Female , Infant , Child, Preschool , Male , Skin Diseases/diagnosis , Referral and Consultation , Germany
Background: Adherence to dermatological treatment is described as poor. Empathy and open communication in the physician-patient relationship has been proven to improve adherence. As direct-to-consumer teledermatology enables patients to access dermatological consultations without in-person interactions, we hypothesized treatment adherence in teledermatology to be low. Methods: The objective of the study was to examine treatment adherence in teledermatology. This retrospective cross-sectional study used data from patients treated through a German direct-to-consumer teledermatology platform between July 2021 and April 2022. Additional information was collected through voluntary follow-up questionnaires provided to patients to assess individual treatment success, treatment-related adverse events, and treatment adherence. Results: Data collection included 771 patients; 61.6% (475/771) were women (mean age 35 years). In 46% (355/771), skin disease had been present for <3 months before teleconsultation. Of all patients who answered the follow-up questionnaire (n = 228), 28.5% (65/228) reported treatment-related adverse events, with skin dryness being the most common (56.9%, 37/65). Adverse events resulting in treatment discontinuation were reported in 1.3% (3/228) of all cases. Improvement in skin condition on therapy was described by 75.4% (172/228). In 85.5% (195/228), full treatment adherence was reported. Conclusion: This is the first study worldwide to examine data on treatment adherence in direct-to-consumer-teledermatology. Despite the lack of doctor-patient interaction, the results of our study demonstrate that most patients show high treatment adherence. Possible drivers contributing to high compliance rates could be the high proportion of new-onset skin diseases, the high treatment success of the prescribed therapies, and the low rate of serious adverse events.
Dermatology , Physicians , Remote Consultation , Skin Diseases , Telemedicine , Humans , Female , Adult , Male , Dermatology/methods , Telemedicine/methods , Retrospective Studies , Cross-Sectional Studies , Skin Diseases/therapy , Treatment Adherence and Compliance , Surveys and Questionnaires
Dermatologic Agents , Psoriasis , Humans , Infliximab/adverse effects , Immune Checkpoint Inhibitors/adverse effects , Psoriasis/chemically induced , Psoriasis/drug therapy , Antibodies, Monoclonal/adverse effects , Dermatologic Agents/adverse effects , Treatment Outcome , Tumor Necrosis Factor-alpha
