{"title":"Can Biologics Be Discontinued in Patients with Psoriatic Arthritis in Stable Remission? A Prospective Single-CenterClinical and Ultrasound Study","authors":"Dario Graceffa, Francesca Sperati, Claudio Bonifati, Gabriele Spoletini, Fulvia Elia, Mauro Caterino, Antonio Cristaudo, Aldo Morrone","doi":"10.1155/2023/5655687","DOIUrl":"https://doi.org/10.1155/2023/5655687","url":null,"abstract":"Biologic disease-modifying antirheumatic drugs (bDMARDs) and particularly tumor necrosis factor inhibitors (TNFi) have dramatically changed the natural history of psoriatic arthritis (PsA), making complete clinical remission possible in most patients. However, TNFi drugs are not without potential adverse effects such as increased infectious risk. In addition, their extensive use is associated with a significant economic burden. This prospective longitudinal cohort study involving 45 PsA patients treated with TNFi in stable remission aimed to evaluate by both clinical examination and ultrasound timing and predictive factors of disease relapse after discontinuation of TNFi treatment. Thirty-nine (86.6%) of 45 enrolled patients experienced disease relapse during the follow-up period, while six patients (13.4%) maintained remission beyond the scheduled 104 weeks. The median survival time of drug-free remission after TNFi discontinuation was 24 weeks (95% confidence interval (CI): 22.6–25.4). Disease relapse was characterized by marked clinical and ultrasound worsening of dermatologic and rheumatologic conditions. However, resuming previously discontinued treatment allowed all patients to quickly regain clinical remission. Interestingly, axial involvement was a key feature of the symptomatological pattern of disease relapse, being the main reason for treatment restart in 26% of our cohort. Based on a multivariate Cox model, three variables (VAS pain, tender joint count, and swollen joint count) of the clinical assessment performed at the time point of TNFi treatment onset negatively influenced the time to disease relapse. In conclusion, temporary discontinuation of TNFi drugs is feasible and relatively safe. However, as few predictors of the risk and timing of disease relapse have been identified, patients should be closely monitored when therapy is discontinued.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"40 11","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135774163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thierry Passeron, Jose Manuel Carrascosa, Richard B. Warren, Andreas Pinter, Marco Romanelli, Patricia Gorecki, Michela Efficace, Steve Fakharzadeh, Ya-Wen Yang, Ahlem Azzabi, Maria Jazra, Katya Lemos, Monica Leung, Yanqing Chen, Diamant Thaçi
{"title":"A Phase IIIb, Multicentre, Interventional, Randomised, Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Guselkumab for the Treatment of Nonpustular Palmoplantar Psoriasis (G-PLUS)","authors":"Thierry Passeron, Jose Manuel Carrascosa, Richard B. Warren, Andreas Pinter, Marco Romanelli, Patricia Gorecki, Michela Efficace, Steve Fakharzadeh, Ya-Wen Yang, Ahlem Azzabi, Maria Jazra, Katya Lemos, Monica Leung, Yanqing Chen, Diamant Thaçi","doi":"10.1155/2023/9967747","DOIUrl":"https://doi.org/10.1155/2023/9967747","url":null,"abstract":"Introduction. Despite the availability of effective biologic therapies for psoriasis, there is no gold-standard treatment for nonpustular palmoplantar psoriasis (ppPsO). Methods. G-PLUS, a phase IIIb, double-blind, placebo-controlled, multicentre clinical trial, randomised adults with moderate-to-severe nonpustular ppPsO and limited plaque psoriasis (Psoriasis Area and Severity Index (PASI) ≥3 but <10) to guselkumab (an interleukin-23p19 blocker) or placebo. Placebo participants were crossed over to receive guselkumab at week (Wk) 16. The primary efficacy endpoint was the proportion of participants achieving palmoplantar PASI (ppPASI) 75 response at Wk16; clinical, biomarker, and quality-of-life endpoints were assessed through Wk48 and safety through Wk56. Results. At Wk16, ppPASI75 response was achieved by 35.9% of the guselkumab participants compared with 28.2% in the placebo group, resulting in a 7.7% difference in response rates (95% confidence interval: −11.5 and 24.7), which was not statistically significant ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M1\"> <mi>p</mi> <mo>=</mo> <mn>0.533</mn> </math> ). More pronounced numerical improvements favouring guselkumab were observed for more stringent efficacy endpoints, such as Wk16 palmoplantar Investigator’s Global Assessment (ppIGA) 0/1 response (guselkumab 34.6% vs. placebo 15.4%). Through Wk48, further improvements were observed in ppPASI75 response (55.1% and 64.1%) and ppIGA 0/1 response (42.3% and 48.7%) for the guselkumab and placebo-crossover groups, respectively. Dermatology Life Quality Index responses showed comparable trends at both timepoints. Safety and pharmacodynamic findings were consistent with the established profile for guselkumab. Serum biomarker levels were significantly reduced with guselkumab and correlated with the baseline PASI score but not the ppPASI score. Conclusion. Although the primary endpoint was not met, analysis of stringent secondary endpoints and post hoc analyses showed numerical improvements favouring guselkumab at Wk16. There were no new safety signals. Further studies are warranted to better understand the impact of guselkumab treatment in patients with ppPsO. This trial is registered with NCT03998683.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135221691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of E-Cadherin Expression in Patients with Pemphigus Vulgaris via Immunohistochemistry","authors":"Saeid Ghorbanivalikchali, Azadeh Rakhshan, Fariba Ghalamkarpour, Fahimeh Abdollahimajd","doi":"10.1155/2023/5592117","DOIUrl":"https://doi.org/10.1155/2023/5592117","url":null,"abstract":"Pemphigus is a group of autoimmune bullous diseases that can affect the skin and mucous membranes, and it is vital to recognize the exact pathogenesis of this disease. This study aimed to investigate the role of E-cadherin in the pathogenesis of pemphigus vulgaris (PV) and compare the expression of E-cadherin in the lesions of PV patients with that in healthy individuals’ skin. Thirty tissue samples from histopathologically confirmed PV patients as the case group and 30 skin samples from healthy individuals as the control group were evaluated for E-cadherin expression via the immunohistochemical method. Data analysis was performed using SPSS software version 25; chi-squared and Fisher’s exact tests were used to examine the relationship between qualitative variables. Immunohistochemical staining revealed decreased E-cadherin expression in the basal and suprabasal layers of the epidermis of PV patients compared with healthy individuals ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M1\"> <mi>P</mi> <mo><</mo> <mn>0.001</mn> </math> ). E-cadherin expression was 1+ in 53.3% of patients, 2+ in 40% of patients, and 3+ in only one (3.3%) patient. On the other hand, the expression of E-cadherin in other layers of the epidermis was 1+ in one patient, 2+ in five patients (25%), and 3+ in 14 patients (70%). Also, the expression of E-cadherin in all layers of the epidermis was 3+ in all controls. E-cadherin expression in the basal and suprabasal layers of the epidermis appears to be lower in patients with PV compared with controls. Therefore, E-cadherin immunohistochemical staining helps diagnose PV along with other diagnostic methods. Moreover, these findings may shed light on the role of E-cadherin as a potential target for disease treatment aiming at disease stabilization. However, more studies are needed to clarify this issue.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"98 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135809686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Safety and Efficacy of Macrofocused Ultrasound without Visualization on Enlarged Facial Pores among Thai Patients: A Pilot Study","authors":"Rungsima Wanitphakdeedecha, Katrina Kashmyr Borjal Kua-Uy, Chadakan Yan, Ya-Nin Nokdhes, Panittra Suphatsathienkul, Thrit Hutachoke, Noldtawat Viriyaskultorn, Thanyaporn Leesanguankul","doi":"10.1155/2023/8154175","DOIUrl":"https://doi.org/10.1155/2023/8154175","url":null,"abstract":"Introduction. Visibly enlarged facial pores are familiar dermatologic concerns. Macrofocused ultrasound energy without visualization (MaFU-WV) showed efficacy in facial tightening and an improvement in skin textural irregularities which opened the potential of the positive effects in reducing the appearance of facial pores. This study aims to assess the safety and efficacy of MaFU-WV in tightening facial pores. Methods. This was a prospective, single-blinded pilot study. Thirty-four Thai subjects with enlarged pores received a single treatment of MaFU-WV using a 2.0 mm transducer on bilateral malar areas of the face. Primary outcome measures included the pore count, pore volume, and pore index measurements using an instrument with a camera for image acquisition and software for analysis of skin. Secondary outcome measures incorporated two blinded dermatologists’ evaluation of clinical photographs and the subjects’ perception of improvement in their facial pores using a 6-point scale. Measurements were taken at baseline, 1 week, 1 month, 3 month, and 6 month after treatment. Results. The pore count significantly decreased from baseline to 6 month after treatment ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M1\"> <mi>p</mi> <mtext> </mtext> <mo><</mo> <mn>0.001</mn> </math> ). Pore volume was significantly lowered from baseline to 1 week and 1, 3, and 6 months after treatment ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M2\"> <mi>p</mi> <mo><</mo> <mn>0.05</mn> </math> ). The pore index was likewise significantly reduced from baseline in every visit ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M3\"> <mi>p</mi> <mo><</mo> <mn>0.05</mn> </math> ). The majority of photographic evaluations by blinded dermatologists were scored as a 1–25% pore minimizing effect across nearly all follow-up visits. On the other hand, patient satisfaction kept improving until the end of the study at 6 months. No adverse events occurred throughout the conduct of the study. Conclusion. Macrofocused ultrasound energy using a 2 mm transducer is a safe and effective treatment for facial pore tightening. The trial is registered with registration number: TCTR20220719001.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"17 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135869611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Emanuele Trovato, Eugenio Capalbo, Alessandra Cartocci, Gionata Buggiani, Aldo Cuccia, Alberto Ghilardi, Salvatore Panduri, Imma Savarese, Serena Guiducci, Francesca Prignano
{"title":"Apremilast in Patients Difficult to Treat: A Multicentric Real-Life Long-Term Experience","authors":"Emanuele Trovato, Eugenio Capalbo, Alessandra Cartocci, Gionata Buggiani, Aldo Cuccia, Alberto Ghilardi, Salvatore Panduri, Imma Savarese, Serena Guiducci, Francesca Prignano","doi":"10.1155/2023/9775738","DOIUrl":"https://doi.org/10.1155/2023/9775738","url":null,"abstract":"Psoriasis is an inflammatory disease nowadays considered not only as a cutaneous but also as a systemic disease. Systemic therapy plays a crucial role in the management of psoriasis. Apremilast is an inhibitor of phosphodiesterase-4 (PDE4), indicated in the treatment of moderate-to-severe psoriasis. Here, we report a multicentric case series of patients treated with apremilast with resolution of skin manifestations and maintenance of clinical response for a minimum of 2 years. By inhibiting PDE4, apremilast acts as a ubiquitous intracellular enzyme, whose active form degrades adenosine cyclic intracellular monophosphate (cAMP) into AMP. The increase in cAMP determines a decrease in proinflammatory cytokines such as TNF-a, IL-17, IL-23, and upregulation of IL-10 with an anti-inflammatory action. Considering the growing incidence of comorbidities in the world population and in particular the strict correlation in patients with psoriasis, it is important to identify therapeutic options able to avoid a negative impact on patients with both conditions. The aim of this work is to highlight the utility of this molecule in the long-term management of these patients. Moreover, these case series further underline the high safety profile and manageability of this small molecule.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"60 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136105987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luca Mastorino, Valentina Celoria, Nicole Macagno, Caterina Cariti, Sara Susca, Niccolò Siliquini, Michela Ortoncelli, Elena Stroppiana, Anna Verrone, Lorenza Burzi, Pietro Quaglino, Simone Ribero, Paolo Dapavo
{"title":"Effectiveness of Brodalumab on Scalp, Palmoplantar, and Genital Psoriasis: A Descriptive Pilot Study","authors":"Luca Mastorino, Valentina Celoria, Nicole Macagno, Caterina Cariti, Sara Susca, Niccolò Siliquini, Michela Ortoncelli, Elena Stroppiana, Anna Verrone, Lorenza Burzi, Pietro Quaglino, Simone Ribero, Paolo Dapavo","doi":"10.1155/2023/1793535","DOIUrl":"https://doi.org/10.1155/2023/1793535","url":null,"abstract":"Introduction. Psoriasis of the scalp, genital areas, and palms and soles represents a treatment challenge in clinical practice. Randomized clinical trials and real-life studies investigating the efficacy of biological drugs in these sites are scarce. The present is a descriptive retrospective real-life study with the aim to evaluate the efficacy and safety of brodalumab in these difficult-to-treat areas. Materials and Methods. 158 psoriatic patients with scalp involvement, 69 with genital involvement, and 54 with palmoplantar involvement being treated with brodalumab were assessed at weeks 16, 28, and 48 using PSSI (Psoriasis Scalp Severity Index), sPGA-G (Physician Global Assessment of Genitalia), and ppPASI (Palmoplantar Psoriasis Area and Severity Index). Results. The achievement of relative PSSIs (75%, 90%, and 100%) was already observed in week 16. 86% achieved PSSI75, 80% PSSI90, and 75% PSSI100. The sPGA-g 0/1 was achieved by 83% of patients at week 16 and 100% at week 24 and 48. At week 16 ppPASI75, 90, and 100 were all reached by 76.9% of patients; at week 24, 84.6% of patients reached all relative ppPASI. Conclusions. Brodalumab proved to be effective and safe in the treatment of scalp, genital, and palmoplantar regions.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"31 24","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136376630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ying-Hua Song, Dan Chen, Shuang Deng, Wei-Na Cai, Liang Zhang
{"title":"Superficial Radiotherapy (SRT-100) as an Effective Noninvasive Treatment for Pyogenic Granuloma: Case Report and Literature Review","authors":"Ying-Hua Song, Dan Chen, Shuang Deng, Wei-Na Cai, Liang Zhang","doi":"10.1155/2023/8829881","DOIUrl":"https://doi.org/10.1155/2023/8829881","url":null,"abstract":"Introduction. Pyogenic granuloma (PG) is a common condition characterized by the appearance of a small raspberry-like vascular growth that may appear on any part of the skin. PG usually occurs secondary to acute or chronic trauma. The primary treatment for PG is noninvasive therapy. In refractory cases, surgical resection is an alternative. Superficial radiation therapy system (SRT-100) is a new technology that uses low-energy radiotherapy to treat nonmelanoma skin cancers. SRT may also be used for the treatment of patients with PG who are unwilling to undergo surgery. Case Presentation. A 27-year-old woman presented with a recurrent neoplasm in the middle finger of the left hand after surgical resection. She refused to undergo reoperation or other aggressive options such as electrocautery or liquid nitrogen cryotherapy, so we prescribed only superficial radiotherapy (SRT-100) alone, with a total dose of 14 Gy in four fractions. Conclusion. The neoplasm gradually flattened after treatment with 14 Gy in four fractions and disappeared completely 3 months after completion of treatment.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"62 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135511806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mesenchymal Stem Cells-Derived Extracellular Vesicles as Nanotherapeutics: An Application for Skin Wound Healing","authors":"Xin-Yu Ben, Meng-Si Tian, Hui-Hui Zheng, Ya-Ru Wang, Tian-Wei Cui, Rui Ren, Xi-Nan Yi, Qi-Fu Li","doi":"10.1155/2023/7916795","DOIUrl":"https://doi.org/10.1155/2023/7916795","url":null,"abstract":"The skin covers the entire outer part of the body as the largest organ. Because this organ is directly exposed to microbial, thermal, mechanical, and chemical damage, several factors may injure it, including acute trauma, chronic wounds, or even surgical procedures. Mesenchymal stem cells- (MSCs-) derived extracellular vesicles (EVs) can inhibit the inflammatory response in the early stage of skin wound healing, promote angiogenesis and the proliferation and migration of epithelial cells, and regulate collagen synthesis and inhibit scar proliferation in the later stage. While MSCs-EVs have broad prospects for clinical applications, it will still be a long way to seamless healing. In this brief review, we focus on the role of MSCs-EV in skin wound repair, therapeutic effects, and potential mechanisms of MSCs-EV in reducing scar formation. It is concluded that MSCs-EV can reduce scar formation in skin wound repair by interfering with multiple inflammatory factors, regulating fibroblast proliferation, and expressing type I and type III collagens at different phases.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135510911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hassan M. Ibrahim, Mohammed H. Hassan, Moustafa A. El-Taieb, Essam Nada, Soheir Abdel-Hamid, Ali Younis, Mahmoud Ali, Eisa M. Hegazy
{"title":"Macrophage Migration Inhibitory Factor and Gene Polymorphism (rs755622G>C) in Unstable Vitiligo Patients","authors":"Hassan M. Ibrahim, Mohammed H. Hassan, Moustafa A. El-Taieb, Essam Nada, Soheir Abdel-Hamid, Ali Younis, Mahmoud Ali, Eisa M. Hegazy","doi":"10.1155/2023/9937187","DOIUrl":"https://doi.org/10.1155/2023/9937187","url":null,"abstract":"Vitiligo pathogenesis is related to the macrophage migration inhibitory factor (MIF) protein. This study aimed to assess the lesional MIF levels and gene polymorphisms (rs755622G>C) in patients with vitiligo. To assess the consequences of combining narrow-band ultraviolet B with oral minipulse prednisolone as opposed to a combination with oral methotrexate on MIF levels in vitiligo patients, 50 unstable vitiligo patients and 50 controls were randomly chosen for comparison. MIF levels in skin homogenates and MIF (rs755622G>C) single nucleotide polymorphisms were assessed using the ELISA and the polymerase chain reaction restriction fragment length polymorphism (RFLP-PCR) techniques. We found significantly higher lesional MIF levels, a higher frequency of both (GC) and (CC) genotypes, and a significantly more frequent mutant allele (C) in patients than in controls. In addition, there was a significantly lower frequency of the allele (C) among patients who exhibited moderate to marked therapeutic improvement than among those who showed minimal to mild improvement. In conclusion, tissue MIF and gene polymorphisms were associated with vitiligo. In addition, oral corticosteroids, narrow-band ultraviolet B, methotrexate-targeted tissue MIF, and gene polymorphisms can improve unstable vitiligo.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"47 34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135618831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of Efficacy and Safety of Topical Nanoliposomal Amphotericin B 0.4% Gel as a Potential Treatment for Onychomycosis: An Interventional Pilot Clinical Study","authors":"Alireza Firooz, Shayan Zamani, Aliasghar Ghadrei, Azin Ayatollahi, Pegah Tamimi, Ali Khamesipour, Mahmoodreza Jafari, Mahsa Fattahi","doi":"10.1155/2023/9955124","DOIUrl":"https://doi.org/10.1155/2023/9955124","url":null,"abstract":"Onychomycosis is a frequent fungal nail disease that is hard to treat and, in most cases, needs long-term therapy with oral agents. Traditionally, oral agents are favored over topical agents, but it should not be overlooked that they come with broad adverse effects and concomitant drug interactions, which can be unsuitable for many individuals. Therefore, alternative approaches need to be addressed by the medical team for numerous cases. On the other hand, local administration of antimicrobials can come as advantageous because of having a more selective site of activity, avoiding off-target systemic adverse effects, and rapid administration at the site of infection. In this study, we are evaluating a new topical delivery method of amphotericin B. To investigate the efficacy and safety of topical nanoliposomal amphotericin B 0.4% as a possible therapeutic option, this pilot, single-group, before-after clinical study was conducted on 15 onychomycosis patients. The evaluation was processed during 36 weeks of follow-up and on three endpoints of week 12, week 24, and week 36, for both clinical and mycological responses. Three patients were excluded; of the remaining 12, 50% showed a complete cure, 16.66% had an effective clinical response, 16.66% had a partial clinical response, and 16.66% showed no response at week 12. Mycological cure was calculated as 50% at week 12. At week 24, our measurements were calculated as 91.66% for complete cure, 8.33% for no response, and 91.66% for mycological cure. One patient reported nail plate detachment at week 2 but continued the topical application; follow-up between weeks 2 and 24 showed a complete cure and regrowth of healthy nails. No other adverse effects were detected. Overall, our study suggests that topical nanoliposomal amphotericin B 0.4% is an effective treatment, which is accessible, affordable, and user-friendly, has minimum adverse effects, and could be regarded as an alternative treatment for those ineligible for systemic therapy. This trial is registered with IRCT20150101020514N18.","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136078842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}