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Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing all 15 studies.
Reviews & meta-analyses: 4 · 2020–2024
Showing all 15 studies, sorted by most relevant.
A. Rai, S. Misra, S. Panda, et al.
Life, 2022
Oral candidiasis is the most common opportunistic fungal infection caused by commensal Candida species. Since there are various local and systemic predisposing factors for the disease, the treatment also varies from topical to systemic antifungal agents. Nystatin is a common antifungal agent used topically. The aim of this systematic review was to evaluate and compare the efficacy of different antifungal agents and the safety of nystatin in the treatment of oral candidiasis. Three electronic databases were searched for randomized controlled trials comparing nystatin with other anti-fungal therapies or placebo. Clinical and/or mycological cure was the outcome evaluation. A meta-analysis and descriptive study on the efficacy, treatment protocols, and safety of nystatin was also conducted. The meta-analysis included five studies, which compared the efficacy of nystatin suspensions with photodynamic therapy. A significant difference in the colony-forming units per milliliters (CFU/mL) of Candida species was observed at 60 days intervals for both palatal mucosa and denture surfaces, with both groups favoring nystatin with low heterogeneity at a 95% confidence interval. Nystatin and photodynamic therapy were found to be equally effective for the clinical remission of denture stomatitis as well as a significant reduction of CFU/mL of Candida species from dentures and palatal surfaces of the patients.
Abstract licence: CC BY
M. Shaikh, A. Alnazzawi, S. Habib, et al.
Prosthesis, 2021
Denture-induced stomatitis (DIS) represents a pathological condition caused by ill-fitting dentures trauma, manifested as inflammation of the palatal tissue beneath the denture. The fungal infections are the principal contributory factors to DIS. Although the aetiology of DIS is multifactorial, the Candida albicans fungal infection remains the main cause. The objective of the present systematic review was to evaluate the latest literature on the addition of nystatin into the tissue conditioners (TCs) in the management of DIS. To search the published literature about “the addition of nystatin in TCs for treating DIS”, electronic databases (PubMed (National library of medicine) and Cochrane Library (Wiley)) were searched (from 1975 until December 2020) using different keywords. Various studies described the effectiveness and efficacy of incorporating nystatin into several TCs. The present systematic review reported that the addition of nystatin is beneficial, with slight or no consequences on both the mechanical and physical features of TCs. Adding nystatin to various TCs for treating DIS can be suggested.
Abstract licence: CC BY
Filipa Sousa, Cecília Nascimento, D. Ferreira, et al.
Advanced drug delivery reviews, 2023
- Antifungal Agents
- Nystatin
- Liposomes
Nystatin is an antifungal molecule with a remarkable yet squandered versatility. In this review, its mechanism of action is explored, along with its extensive action spectrum and toxicity. A multitude of methodologies to tackle the drug's physical and chemical hurdles are outlined along with some proven-effective strategies to increase its activity and/or decrease its toxicity. A separate detailed section focused on micro and nanotechnology solutions addresses new drug delivery systems made of polymeric, metallic or lipid materials. Although the topical route depicts greater representativeness amongst these formulations, the intravenous, dental, oral, vaginal and inhalation routes are also mentioned. The unsuccessful previous attempts at developing parenteral formulations of nystatin or even the withdrawal of a nystatin-loaded multilamellar liposome should not divert research away from this drug. In fact, the interest in nystatin ought to be reawakened with the ongoing clinical trials on the promising nystatin-like genetically engineered derivate BSG005.
Abstract licence: CC BY
Leung AK, Barankin B, Lam JM, et al.
2023
Background: Tinea pedis is one of the most common superficial fungal infections of the skin, with various clinical manifestations. This review aims to familiarize physicians with the clinical features, diagnosis and management of tinea pedis. Methods: A search was conducted in April 2023 in PubMed Clinical Queries using the key terms 'tinea pedis' OR 'athlete's foot'. The search strategy included all clinical trials, observational studies and reviews published in English within the past 10 years. Results: . It is estimated that approximately 3% of the world population have tinea pedis. The prevalence is higher in adolescents and adults than in children. The peak age incidence is between 16 and 45 years of age. Tinea pedis is more common amongst males than females. Transmission amongst family members is the most common route, and transmission can also occur through indirect contact with contaminated belongings of the affected patient. Three main clinical forms of tinea pedis are recognized: interdigital, hyperkeratotic (moccasin-type) and vesiculobullous (inflammatory). The accuracy of clinical diagnosis of tinea pedis is low. A KOH wet-mount examination of skin scrapings of the active border of the lesion is recommended as a point-of-care testing. The diagnosis can be confirmed, if necessary, by fungal culture or culture-independent molecular tools of skin scrapings. Superficial or localized tinea pedis usually responds to topical antifungal therapy. Oral antifungal therapy should be reserved for severe disease, failed topical antifungal therapy, concomitant presence of onychomycosis or in immunocompromised patients. Conclusion: Topical antifungal therapy (once to twice daily for 1-6 weeks) is the mainstay of treatment for superficial or localized tinea pedis. Examples of topical antifungal agents include allylamines (e.g. terbinafine), azoles (e.g. ketoconazole), benzylamine, ciclopirox, tolnaftate and amorolfine. Oral antifungal agents used for the treatment of tinea pedis include terbinafine, itraconazole and fluconazole. Combined therapy with topical and oral antifungals may increase the cure rate. The prognosis is good with appropriate antifungal treatment. Untreated, the lesions may persist and progress.
Abstract licence: CC BY-NC-ND
S. Nile, Dipalee Thombre, Amruta V. Shelar, et al.
Molecules, 2023
- Selenium
- Nanoparticles
- Antifungal Agents
In the present study, biogenic selenium nanoparticles (SeNPs) have been prepared using Paenibacillus terreus and functionalized with nystatin (SeNP@PVP_Nystatin nanoconjugates) for inhibiting growth, morphogenesis, and a biofilm in Candida albicans. Ultraviolet–visible spectroscopy analysis has shown a characteristic absorption at 289, 303, and 318 nm, and X-ray diffraction analysis has shown characteristic peaks at different 2θ values for SeNPs. Electron microscopy analysis has shown that biogenic SeNPs are spherical in shape with a size in the range of 220–240 nm. Fourier transform infrared spectroscopy has confirmed the functionalization of nystatin on SeNPs (formation of SeNP@PVP_Nystatin nanoconjugates), and the zeta potential has confirmed the negative charge on the nanoconjugates. Biogenic SeNPs are inactive; however, nanoconjugates have shown antifungal activities on C. albicans (inhibited growth, morphogenesis, and a biofilm). The molecular mechanism for the action of nanoconjugates via a real-time polymerase chain reaction has shown that genes involved in the RAS/cAMP/PKA signaling pathway play an important role in antifungal activity. In cytotoxic studies, nanoconjugates have inhibited only 12% growth of the human embryonic kidney cell line 293 cells, indicating that the nanocomposites are not cytotoxic. Thus, the biogenic SeNPs produced by P. terreus can be used as innovative and effective drug carriers to increase the antifungal activity of nystatin.
Abstract licence: CC BY
Tikrit Journal of Pure Science, 2023
Two silver nanoparticles containing compounds were prepared by simple chemical reactions and characterized by X-ray diffraction (XRD), infra-red spectrum (FTIR) and atomic force microscope (AFM). These functionalized silver nanoparticles were used to study their biological activity against four types of fungi. These compounds proved to have high inhibition effect against all types of studied fungi. Due to the presence of silver nanoparticles which increases nystatin and clotrimazol interact with the fungi.
Abstract licence: CC BY
A. Tevyashova, S. Efimova, Alexander Alexandrov, et al.
Antibiotics, 2023
Polyene antifungal amphotericin B (AmB) has been used for over 60 years, and remains a valuable clinical treatment for systemic mycoses, due to its broad antifungal activity and low rate of emerging resistance. There is no consensus on how exactly it kills fungal cells but it is certain that AmB and the closely-related nystatin (Nys) can form pores in membranes and have a higher affinity towards ergosterol than cholesterol. Notably, the high nephro- and hemolytic toxicity of polyenes and their low solubility in water have led to efforts to improve their properties. We present the synthesis of new amphotericin and nystatin amides and a comparative study of the effects of identical modifications of AmB and Nys on the relationship between their structure and properties. Generally, increases in the activity/toxicity ratio were in good agreement with increasing ratios of selective permeabilization of ergosterol- vs. cholesterol-containing membranes. We also show that the introduced modifications had an effect on the sensitivity of mutant yeast strains with alterations in ergosterol biosynthesis to the studied polyenes, suggesting a varying affinity towards intermediate ergosterol precursors. Three new water-soluble nystatin derivatives showed a prominent improvement in safety and were selected as promising candidates for drug development.
Abstract licence: CC BY
A. El-Batal, Hanady G. Nada, Reham R El-Behery, et al.
RSC Advances, 2020
, respectively. The present research provides a revolutionary nano-drug-based solution to address the increasing global resistance of pathogenic microbes at low concentrations, thus offering a new infectious disease treatment technique that is cost effective, eco-friendly, and works in an acceptable time frame.
Abstract licence: CC BY
L. Powell, Jennifer M. Adams, S. Quoraishi, et al.
Frontiers in Cellular and Infection Microbiology, 2023
- Antifungal Agents
- Candidiasis
- Adenosine Triphosphate
Background The increasing prevalence of invasive fungal infections in immuno-compromised patients is a considerable cause of morbidity and mortality. With the rapid emergence of antifungal resistance and an inadequate pipeline of new therapies, novel treatment strategies are now urgently required. Methods The antifungal activity of the alginate oligosaccharide OligoG in conjunction with nystatin was tested against a range of Candida spp. ( C. albicans , C. glabrata , C. parapsilosis , C. auris , C. tropicalis and C. dubliniensis ), in both planktonic and biofilm assays, to determine its potential clinical utility to enhance the treatment of candidal infections. The effect of OligoG (0-6%) ± nystatin on Candida spp. was examined in minimum inhibitory concentration (MIC) and growth curve assays. Antifungal effects of OligoG and nystatin treatment on biofilm formation and disruption were characterized using confocal laser scanning microscopy (CLSM), scanning electron microscopy (SEM) and ATP cellular viability assays. Effects on the cell membrane were determined using permeability assays and transmission electron microscopy (TEM). Results MIC and growth curve assays demonstrated the synergistic effects of OligoG (0-6%) with nystatin, resulting in an up to 32-fold reduction in MIC, and a significant reduction in the growth of C. parapsilosis and C. auris (minimum significant difference = 0.2 and 0.12 respectively). CLSM and SEM imaging demonstrated that the combination treatment of OligoG (4%) with nystatin (1 µg/ml) resulted in significant inhibition of candidal biofilm formation on glass and clinical grade silicone surfaces ( p < 0.001), with increased cell death ( p < 0.0001). The ATP biofilm disruption assay demonstrated a significant reduction in cell viability with OligoG (4%) alone and the combined OligoG/nystatin (MIC value) treatment ( p < 0.04) for all Candida strains tested. TEM studies revealed the combined OligoG/nystatin treatment induced structural reorganization of the Candida cell membrane, with increased permeability when compared to the untreated control ( p < 0.001). Conclusions Antimicrobial synergy between OligoG and nystatin against Candida spp. highlights the potential utility of this combination therapy in the prevention and topical treatment of candidal biofilm infections, to overcome the inherent tolerance of biofilm structures to antifungal agents.
Abstract licence: CC BY
Mohammed A Aljaffary, H. Jang, N. Alomeir, et al.
Clinical Oral Investigations, 2023
- Dental Caries
- Dental Plaque
- Antifungal Agents
OBJECTIVES: To examine the effect of Nystatin oral rinse on oral Candida species and Streptococcus mutans carriage. MATERIALS AND METHODS: Twenty healthy adults with oral candidiasis participated in the single-arm clinical trial and received Nystatin oral rinse for 7 days, 4 applications/day, and 600,000 International Units/application. Demographic-socioeconomic-oral-medical conditions were obtained. Salivary and plaque Candida species and Streptococcus mutans were assessed at baseline and 1-week and 3-month follow-ups. Twenty-four salivary cytokines were assessed. Candida albicans isolates underwent Nystatin susceptibility test. RESULTS: Half of participants (10/20) were free of salivary C. albicans after using Nystatin rinse. Salivary S. mutans was significantly reduced at 3-month follow-up (p < 0.05). Periodontal status reflected by bleeding-on-probing was significantly improved at 1-week and 3-month follow-ups (p < 0.05). Plaque accumulation was significantly reduced at 1-week follow-up (p < 0.05). Interestingly, the responses to Nystatin oral rinse were not associated with race, gender, age, oral hygiene practice, adherence to Nystatin rinse, or sweet consumption (p > 0.05). No C. albicans isolates were resistant to Nystatin. Furthermore, salivary cytokine eotaxin and fractalkine were significantly reduced at 3-month follow-up among participants who responded to Nystatin rinse (p < 0.05). CONCLUSIONS: The study results indicate that oral antifungal treatment had an effect on S. mutans salivary carriage. Future clinical trials are warranted to comprehensively assess the impact of antifungal treatment on the oral flora other than S. mutans and Candida. CLINICAL RELEVANCE: Due to the potential cariogenic role of oral Candida species, antifungal approaches shed new light on the prevention and management of dental caries from a fungal perspective.
Abstract licence: CC BY
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Scientific data (pharmacology, interactions, ADME) is not yet available for this medicine. Clinical sections are sourced from the NHS dm+d database.