Steven R Feldman’s research while affiliated with University of Southern Denmark and other places

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Publications (881)


Medications Associated With Generalized Pustular Psoriasis Flares: A Retrospective Pharmacovigilance Study
  • Article

April 2025

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2 Reads

Journal of Cutaneous Maedicine and Surgery

Gaurav N. Pathak

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Steven R. Feldman

A Review on Homemade Sunscreen

April 2025

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17 Reads

The making of homemade versions of sunscreens is becoming a popular movement across social media platforms, as proponents claim these alternatives are safer and effective. There is a scarcity of information on the make-up of common homemade recipes and the ways in which they compare to FDA-approved sunscreens. Objective This review discusses the main components and implications of social media-derived homemade sunscreen alternatives. We conducted a review of the common ingredients used in homemade sunscreen recipes. Common homemade sunscreen recipes are composed of a base of sun protective filter, a water protective agent, an emollient oil, and an essential oil. The self-made versions are thought to be effective alternatives without the addition of harmful ingredients. Though many of these recipes contain more natural ingredients, they do not undergo the same scientific testing protocols to offer information on sun protective factor and safety. Understanding the limitations of homemade skincare alternatives may help clinicians counsel their patients on the potential risks associated with its use and reveal potential health concerns related to the spread of misinformation across popular media platforms.




Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne: Association of Efficacy With Cutaneous Safety/Tolerability Events
  • Article
  • Full-text available

March 2025

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20 Reads

SKIN The Journal of Cutaneous Medicine

Background: Topical treatment of acne—particularly with retinoids—often incurs a transient period of dermal irritation characterized by erythema, scaling, and other dermal changes that may reflect the same mechanisms of action by which acne pathophysiology is addressed. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated efficacy in the treatment of acne, with a safety/tolerability profile typical of topical acne treatment. The objective of this post-hoc analysis is to determine whether CAB efficacy was related to occurrence of cutaneous safety/tolerability events. Methods: Data were pooled from 4 double-blind, 12-week studies of participants with moderate-to-severe acne. Efficacy endpoints included treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]) and reductions from baseline in inflammatory (IL) and noninflammatory lesions (NIL). Cutaneous safety/tolerability assessments of erythema and scaling (investigator-assessed) and itching, burning, and stinging (participant-assessed) were graded on a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe). To determine if CAB efficacy was associated with cutaneous events, efficacy endpoints at week 12 were compared for CAB-treated participants who experienced no increase versus ≥1-grade (any) increase in any safety/tolerability score at weeks 2, 4, or 8. Results: At week 12, CAB-treated participants experiencing any safety/tolerability event (n=411) had significantly greater rates of treatment success and IL reductions, and numerically greater NIL reductions, than those without events (n=188; treatment success: 55.0% vs 43.0%; P<0.01; IL reductions: 79.1% vs 72.3%; P<0.001; NIL reductions: 73.1% vs 68.1%). At weeks 2, 4, and 8, IL/NIL reductions were significantly greater among participants experiencing any cutaneous event than those without events (P<0.05, all). Overall, improved efficacy appeared to be driven by events of scaling, itching, and burning. Conclusions: Across four clinical studies, CAB-treated participants who experienced safety/tolerability events at weeks 2, 4, or 8 also experienced greater lesion reductions across 12 weeks of treatment and greater rates of treatment success at week 12. These findings are consistent with the theory that early instances of cutaneous irritation during topical acne treatment may reflect therapeutic mechanisms of action. Setting patient expectations regarding the potential for transient irritation during treatment may contribute to greater adherence and efficacy with CAB gel. Funding: Ortho Dermatologics

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Early Acne Improvements With Fixed-Combination Topical Therapy: Analysis of the First 4 Weeks of Treatment

March 2025

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42 Reads

SKIN The Journal of Cutaneous Medicine

Background: Acne treatment can take weeks to result in noticeable improvements, which may diminish patients’ perception of treatment effectiveness and negatively affect treatment adherence. Acne treatments that deliver early visible improvements may encourage treatment adherence and bolster overall treatment effectiveness. Combination topical treatments that target multiple acne pathophysiological pathways are more efficacious than monotherapies and simplifying the treatment regimen by delivering multiple active ingredients as fixed combinations may improve adherence. Objective: To evaluate early acne improvements in clinical trials of fixed-combination acne topicals. Methods: Week 4 efficacy data for fixed-combination topical treatments were gathered from US Food and Drug Administration medical reviews, prescribing information, and/or publications of pivotal phase 2 and phase 3 clinical trials of 7 acne topicals, comprising fixed combinations of adapalene (ADAP), benzoyl peroxide (BPO), clindamycin phosphate (CLIN), and tretinoin. For the triple-combination formulation (CLIN 1.2%/ADAP 0.15%/BPO 3.1% gel), data from a nonpivotal phase 2 study with dyad combination treatment arms were also included. Outcomes included reductions from baseline in inflammatory lesions (ILs) and noninflammatory lesions (NILs) and treatment success (≥2-grade reduction in global acne severity score and clear/almost clear skin). Results: At week 4, IL reductions from baseline ranged from 32-54% while NIL reductions ranged from 25-45%. Rates of treatment success ranged from 3-12%. Overall, efficacy was greatest with triple-combination CLIN 1.2%/ADAP 0.15%/BPO 3.1% gel (IL: 54-55%; NIL: 43-45%; treatment success: 8-12%), followed by combinations of ADAP/BPO (IL: ~42-48%; NIL: ~38%; treatment success: 4-~7%). None of the branded topical products were evaluated in a head-to-head study. Conclusions: In pivotal clinical trials of topical fixed-combination formulations for acne, triple-combination CLIN 1.2%/ADAP 0.15%/BPO 3.1% gel yielded greater lesion reductions and rates of treatment success after 4 weeks of treatment than dyad formulations. Even greater differences may be expected with real-world world use, as early improvements may foster better long-term outcomes by increasing patients’ confidence in and adherence to the treatment. Funding: Ortho Dermatologics


Wound Care Biomarkers

March 2025

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1 Read

The wound healing process is a physiologic immune response to tissue insult. However, the cellular and molecular mechanisms that contribute to this response are still not completely understood, and there exists many opportunities for this physiologic response to become pathologic resulting in the formation of scars or ulcers. Developing new and effective biomarkers is a key to helping our patients with this painful and often recalcitrant problem.


Merkel Cell Carcinoma Biomarkers

March 2025

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2 Reads

Merkel cell carcinoma (MCC) is an aggressive malignant neuroendocrine tumor of the skin. While considerable advances in the management of MCC have been made, the clinical utility of potential biomarkers remains unclear. Biomarkers play a crucial role in assessing prognosis, diagnosis, and therapeutic interventions in many chronic diseases and may be similarly beneficial in MCC. This chapter focuses on examining potential biomarkers in MCC. Through conducting a literature search, 22 biomarkers were identified and classified based on the classification standards provided by the World Health Organization (WHO). These biomarkers have the potential to aid in screening, diagnosis, prognosis, monitoring, and pharmacodynamic properties of MCC.


Biomarkers in Atopic Dermatitis

March 2025

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5 Reads

Atopic dermatitis (AD) is an inflammatory skin disorder characterized by periods of chronic skin flares. Currently available treatment options include topical therapies, phototherapy, and immunosuppressants, but these therapeutics have undesired side effects and the variability in patient presentation requires individualized treatment plans. Biomarkers have a large role in many fields of medicine and could potentially assess limitations in disease diagnosis, prognosis, and management of AD. This chapter focused on analyzing the biomarkers most closely associated with clinical outcomes in AD patients. We conducted a literature review of twelve biomarkers and used classification standards provided by the World Health Organization. Through our review we found that there are measurable levels of cytokines, antibodies, and proteins that are associated with AD diagnosis, prognosis, and responses to treatment. While there are biomarkers being investigated for their use in AD management, the benefit for such laboratory medicine in a historically clinically diagnosed disease is not known.


Melanoma Biomarkers

March 2025

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17 Reads

Melanoma is a skin cancer that originates from melanocytes, cells that sit in the basal layer of the epidermis and synthesize melanin. The gold standard for the diagnosis is histopathologic evaluation; however, melanoma can show a wide range of histopathologic features, including subtle histologic atypia, which can pose diagnostic challenges. Additionally, there are other melanocytic tumors that remain incompletely understood, designated as melanocytic tumors of uncertain malignant potential (MELTUMP). Biomarkers could potentially address limitations in disease screening, diagnosis, prognosis, and management of melanoma. This chapter focuses on analyzing the biomarkers most closely associated with clinical outcomes in melanoma patients. We conducted a literature review of 14 biomarkers and used classification standards provided by the World Health Organization (WHO). In this review, we discuss the measurable levels of antigens, proteins, and antibodies associated with melanoma diagnosis, prognosis, and response to treatment. The presence and extent of immunohistochemical staining, the serum levels of biomarkers, and the presence of inflammatory cell infiltrates can be analyzed to identify patients who qualify for further testing for melanoma, to distinguish malignant melanoma from benign nevi, to differentiate melanoma from other tumor types, to predict patient outcomes, to monitor the progression of melanoma, and to predict response to therapies.


Citations (27)


... Biologics include TNF inhibitors; infliximab, etanercept, ADA, golimumab and certolizumab pegol [58]. However, use is often restricted due to cost, and adverse side effects that include risk of opportunistic infection, hepatotoxicity, and injection-site reactions [56]. Phototherapy has shown promise as another treatment option for systemic psoriatic disease. ...

Reference:

JAK/STAT Pathway in Psoriasis and Psoriatic Arthritis: Insights into Inflammation and Tissue Remodeling
Therapeutic Advancements in Psoriasis and Psoriatic Arthritis

... A comprehensive search of the databases identified a total of 668 abstracts, with an additional 14 studies found through hand-searching relevant review articles. After the initial screening process, 27 studies were deemed eligible for full-text screening, of which 12 studies met the inclusion criteria [15,16,[24][25][26][27][28][29][30][31][32][33] (Figure 1). These studies encompassed a combined total of 2502 participants, including 1326 in the reference-reference group and 1176 in the reference-biosimilar group. ...

Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52

... In 48-week phase 3 trials (ARCADIA 1 and ARCADIA 2), patients received a loading dose of 60 mg followed by 30 mg Q4 W. Patients also received TCS/TCI therapy for 2-4 weeks prior to baseline and during the study, with optional tapering with improvement. Those who obtained an IGA of 0/1 or EASI-75 by week 16 were further randomized 1:1:1 to receive 30 Q4 W, 30 Q8 W, or placebo dosing for 32 additional weeks [49,51]. At week 16, IGA 0/1 was achieved by at least 35% of the treatment arm, in comparison to 24% in the placebo arm, and 42% of patients on nemolizumab attained an EASI-75, in comparison to 29.0% of placebo patients [49]. ...

The role of nemolizumab in the treatment of atopic dermatitis for the adult population
  • Citing Article
  • August 2024

... Similarly, among participants recruited through Craigslist advertisements, there was a positive correlation between the total number of body modifications a participant had (piercing, tattooing, scarification, etc.) and their degree of BPD symptoms [19]. Finally, some who engage in NSSI obtain tattoos to cover up scars or to prevent further NSSI [20], as they may not want to scar their tattoos. ...

Self-Inflicted Lesions in Dermatology: The Scars of Self-Harm

JAAD Reviews

... Given the overlapping pathogenesis of GPP and plaque psoriasis, traditional drug therapies often yield unsatisfactory results, and biological agents, such as ixekizumab and secukinumab, exhibit varying efficacy levels in patients with GPP. The first IL-36R antagonist, spesolimab, has been approved by the National Medical Products Administration (NMPA) for GPP treatment (16); however, its limited accessibility in primary hospitals due to high costs necessitates the urgent exploration of other safe and effective treatment options. ...

Spesolimab: A Review of the First IL-36 Blocker Approved for Generalized Pustular Psoriasis
  • Citing Article
  • May 2024

Annals of Pharmacotherapy

... There are increasing amounts of data regarding the real-world efficacy and safety of patients with PsO who are treated with ixekizumab [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39], and currently, interest in realworld data regarding its efficacy and safety profile in PsA is increasing [31,[40][41][42][43][44][45][46][47][48][49][50][51][52]. Indeed, real-world studies offer additional clinical insights into the disease in a heterogenous context such as the clinical setting, when patients comorbidities and contextual factors can impact the management of the disease and its outcome as well as the drug retention rate (DRR) [53,54]. ...

Comparative analysis of persistence and remission with guselkumab versus secukinumab and ixekizumab in the United States

... As outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline for clinical studies, a risk-based approach was taken to the clinical evaluation of SB17. On the basis of the previous clinical trial results (phase I and III), it was confirmed that the clinical profile of SB17 was comparable to that of ustekinumab RP [6,16]. To assess the structural and functional similarity of SB17 to ustekinumab RP, a comprehensive analysis was conducted using state-of-the-art analytical methods, and similarity was established between ustekinumab RP and SB17. ...

A Randomized, Double-blind, Phase III Study Assessing Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis
  • Citing Article
  • April 2024

Journal of the American Academy of Dermatology

... However, the exorbitant cost associated with its clinical implementation renders it financially unattainable for a majority of patients [21,22]. In addition, the presence of serious side effects in current treatment modalities, such as immune dysregulation, hematopoietic dysfunction, skin atrophy, and telangiectasia, should be acknowledged [23,24]. These situations have compelled us to conduct further research in order to discover pharmaceuticals that are both and promote the expression of proinflammatory cytokines IL-1, IL-6, IL-1β, and TNF-α [38], further regulating M1 macrophage polarization [39,40]. ...

Clinical pharmacokinetics and pharmacodynamics of topical non-biological therapies for psoriasis patients
  • Citing Article
  • March 2024

... [1][2][3] It is an uncommon inflammatory papulosquamous skin disorder characterized by hyperkeratotic follicular papules that coalesce into scaly, orange-red plaques accompanied by palmoplantar keratoderma. [4][5][6][7][8] In some cases, patients develop erythroderma, leaving islands of unaffected skin. 9 It can present either acquired or familial, in childhood or adulthood, with either generalized or localized involvement. ...

Biologics for Treatment of Pityriasis Rubra Pilaris: A Literature Review
  • Citing Article
  • March 2024

Journal of Cutaneous Maedicine and Surgery

... However, prolonged administration may result in stria and cutaneous atrophy, as well as systemic adverse effects such as topical steroid withdrawal (7). Oral systemic nonbiologic therapies for psoriasis patients include oral acitretin, methotrexate, cyclosporine, apremilast, tofacitinib, and deucravacitinib (8). At present, a diverse array of biological treatments are accessible for moderate to severe psoriasis, encompassing inhibitors, IL12/23 inhibitors, IL17 inhibitors, and IL23 inhibitors (3,9). ...

Clinical pharmacokinetics and pharmacodynamics of oral systemic nonbiologic therapies for psoriasis patients
  • Citing Article
  • March 2024