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Journal of the American Podiatric... Jul 2015New therapies for onychomycosis continue to be developed, yet treatments are seldom directly compared in randomized controlled trials. The objective of this study was to... (Review)
Review
New therapies for onychomycosis continue to be developed, yet treatments are seldom directly compared in randomized controlled trials. The objective of this study was to compare the rates of mycological cure for oral and topical onychomycosis treatments using network meta-analysis. A systematic review of the literature on onychomycosis treatments published before March 25, 2013, was performed, and data were analyzed using network meta-analysis. Terbinafine, 250 mg, therapy was significantly superior to all treatments except itraconazole, 400 mg, pulse therapy; itraconazole, 200 mg, therapy was significantly superior to fluconazole and the topical treatments; and fluconazole, efinaconazole, ciclopirox, terbinafine nail solution, and amorolfine treatments were significantly superior to only placebo. These results support the superiority of 12-week continuous terbinafine, 250 mg, therapy and itraconazole, 400 mg, pulse therapy (1 week per month for 3 months) while suggesting the equivalence of topical therapies. These results reflect findings from the literature and treatment efficacy observed in clinical practice.
Topics: Administration, Topical; Antifungal Agents; Foot Dermatoses; Humans; Network Meta-Analysis; Onychomycosis; Treatment Outcome
PubMed: 25032982
DOI: 10.7547/13-110.1 -
Journal of the American Podiatric... 2023Onychomycosis is the most common nail disorder, with a global prevalence of approximately 5.5%. It is difficult to cure on both short-term and long-term bases. The most...
Onychomycosis is the most common nail disorder, with a global prevalence of approximately 5.5%. It is difficult to cure on both short-term and long-term bases. The most common treatments include the use of oral or topical antifungals. Recurrent infections are common, and the use of systemic oral antifungals raises concerns of hepatotoxicity and drug-drug interactions, particularly in patients with polypharmacy. A number of device-based treatments have been developed for onychomycosis treatment, to either directly treat fungal infection or act as adjuvants to increase the efficacy of topical and oral agents. These device-based treatments have been increasing in popularity over the past several years, and include photodynamic therapy, iontophoresis, plasma, microwaves, ultrasound, nail drilling, and lasers. Some, such as photodynamic therapy, provide more direct treatment, whereas others, such as ultrasound and nail drilling, aid the uptake of traditional antifungals. We conducted a systematic literature search investigating the efficacy of these device-based treatment methods. From an initial result of 841 studies, 26 were deemed relevant to the use of device-based treatments of onychomycosis. This review examines these methods and provides insight into the state of clinical research for each. Many device-based treatments show promising results, but require more research to assess their true impact on onychomycosis.
Topics: Humans; Onychomycosis; Antifungal Agents; Nails; Photochemotherapy; Administration, Topical
PubMed: 36905611
DOI: 10.7547/21-240 -
American Journal of Therapeutics 2019Onychomycoses are fungal nail infections affecting predominantly toenails, and mainly caused by dermatophyte fungi, molds and some Candida species. Nail infections can...
BACKGROUND
Onychomycoses are fungal nail infections affecting predominantly toenails, and mainly caused by dermatophyte fungi, molds and some Candida species. Nail infections can be mild with purely cosmetic implications, but they can also negatively influence quality of life. The deep-seated nature of fungi within the nail plate, prolonged treatment, poor patient adherence, frequent recurrences, and development of resistance to various antimicrobial agents make onychomycosis difficult to successfully treat.
AREAS OF UNCERTAINTY
When and how should clinicians prescribe systemic and topical antifungal drugs for onychomycosis?
DATA SOURCES
A narrative review was undertaken of the current literature identified in Medline, Scopus, CINAHL, the Cochrane library, and Google Scholar.
RESULTS
Treatment is often lengthy and requires persistence and patient education. Definitive mycological diagnosis, and an individualized evaluation of risks and benefits of different treatments are imperative before initiating therapy. The choice of treatment can be influenced by the age and general health of the patient, the causative organism, the number of affected nails, and the extent of nail involvement. Oral antifungals offer greater likelihood of a cure than topicals, but oral therapy carries greater risks and requires closer monitoring. Oral terbinafine is the treatment of choice, followed by itraconazole pulse regimen. The newly approved topical agents, efinaconazole and tavaborole, were superior to placebo in clinical trials and appear to produce slightly improved mycological cure rates compared to previous topicals, but further direct comparisons are needed.
CONCLUSIONS
The treatment of onychomycosis can be challenging, as most therapeutic options are lengthy, expensive and potentially unsuccessful.
Topics: Administration, Oral; Administration, Topical; Antifungal Agents; Clinical Trials as Topic; Humans; Medication Adherence; Onychomycosis; Patient Education as Topic; Quality of Life; Recurrence; Time Factors; Treatment Outcome
PubMed: 31082864
DOI: 10.1097/MJT.0000000000000696 -
The Cochrane Database of Systematic... Jan 2020Onychomycosis refers to fungal infections of the nail apparatus that may cause pain, discomfort, and disfigurement. This is an update of a Cochrane Review published in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Onychomycosis refers to fungal infections of the nail apparatus that may cause pain, discomfort, and disfigurement. This is an update of a Cochrane Review published in 2007; a substantial amount of new research warrants a review exclusively on toenails.
OBJECTIVES
To assess the clinical and mycological effects of topical drugs and device-based therapies for toenail onychomycosis.
SEARCH METHODS
We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials.
SELECTION CRITERIA
Randomised controlled trials of topical and device-based therapies for onychomycosis in participants with toenail onychomycosis, confirmed by positive cultures, direct microscopy, or histological nail examination. Eligible comparators were placebo, vehicle, no treatment, or an active topical or device-based treatment.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes were complete cure rate (normal-looking nail plus fungus elimination, determined with laboratory methods) and number of participants reporting treatment-related adverse events.
MAIN RESULTS
We included 56 studies (12,501 participants, average age: 27 to 68 years), with mainly mild-to-moderate onychomycosis without matrix involvement (where reported). Participants had more than one toenail affected. Most studies lasted 48 to 52 weeks; 23% reported disease duration (variable). Thirty-five studies specifically examined dermatophyte-caused onychomycosis. Forty-three studies were carried out in outpatient settings. Most studies assessed topical treatments, 9% devices, and 11% both. We rated three studies at low risk of bias across all domains. The most common high-risk domain was performance bias. We present results for key comparisons, where treatment duration was 36 or 48 weeks, and clinical outcomes were measured at 40 to 52 weeks. Based on two studies (460 participants), compared with vehicle, ciclopirox 8% lacquer may be more effective in achieving complete cure (risk ratio (RR) 9.29, 95% confidence interval (CI) 1.72 to 50.14; low-quality evidence) and is probably more effective in achieving mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence). Ciclopirox lacquer may lead to increased adverse events, commonly application reactions, rashes, and nail alteration (e.g. colour, shape). However, the 95% CI indicates that ciclopirox lacquer may actually make little or no difference (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence). Efinaconazole 10% solution is more effective than vehicle in achieving complete cure (RR 3.54, 95% CI 2.24 to 5.60; 3 studies, 1716 participants) and clinical cure (RR 3.07, 95% CI 2.08 to 4.53; 2 studies, 1655 participants) (both high-quality evidence) and is probably more effective in achieving mycological cure (RR 2.31, 95% CI 1.08 to 4.94; 3 studies, 1716 participants; moderate-quality evidence). Risk of adverse events (such as dermatitis and vesicles) was slightly higher with efinaconazole (RR 1.10, 95% CI 1.01 to 1.20; 3 studies, 1701 participants; high-quality evidence). No other key comparison measured clinical cure. Based on two studies, compared with vehicle, tavaborole 5% solution is probably more effective in achieving complete cure (RR 7.40, 95% CI 2.71 to 20.24; 1198 participants), but probably has a higher risk of adverse events (application site reactions were most commonly reported) (RR 3.82, 95% CI 1.65 to 8.85; 1186 participants (both moderate-quality evidence)). Tavaborole improves mycological cure (RR 3.40, 95% CI 2.34 to 4.93; 1198 participants; high-quality evidence). Moderate-quality evidence from two studies (490 participants) indicates that P-3051 (ciclopirox 8% hydrolacquer) is probably more effective than the comparators ciclopirox 8% lacquer or amorolfine 5% in achieving complete cure (RR 2.43, 95% CI 1.32 to 4.48), but there is probably little or no difference between the treatments in achieving mycological cure (RR 1.08, 95% CI 0.85 to 1.37). We found no difference in the risk of adverse events (RR 0.60, 95% CI 0.19 to 1.92; 2 studies, 487 participants; low-quality evidence). The most common events were erythema, rash, and burning. Three studies (112 participants) compared 1064-nm Nd:YAG laser to no treatment or sham treatment. We are uncertain if there is a difference in adverse events (very low-quality evidence) (two studies; 85 participants). There may be little or no difference in mycological cure at 52 weeks (RR 1.04, 95% CI 0.59 to 1.85; 2 studies, 85 participants; low-quality evidence). Complete cure was not measured. One study (293 participants) compared luliconazole 5% solution to vehicle. We are uncertain whether luliconazole leads to higher rates of complete cure (very low-quality evidence). Low-quality evidence indicates there may be little or no difference in adverse events (RR 1.02, 95% CI 0.90 to 1.16) and there may be increased mycological cure with luliconazole; however, the 95% CI indicates that luliconazole may make little or no difference to mycological cure (RR 1.39, 95% CI 0.98 to 1.97). Commonly-reported adverse events were dry skin, paronychia, eczema, and hyperkeratosis, which improved or resolved post-treatment.
AUTHORS' CONCLUSIONS
Assessing complete cure, high-quality evidence supports the effectiveness of efinaconazole, moderate-quality evidence supports P-3051 (ciclopirox 8% hydrolacquer) and tavaborole, and low-quality evidence supports ciclopirox 8% lacquer. We are uncertain whether luliconazole 5% solution leads to complete cure (very low-quality evidence); this outcome was not measured by the 1064-nm Nd:YAG laser comparison. Although evidence supports topical treatments, complete cure rates with topical treatments are relatively low. We are uncertain if 1064-nm Nd:YAG laser increases adverse events compared with no treatment or sham treatment (very low-quality evidence). Low-quality evidence indicates that there is no difference in adverse events between P-3051 (ciclopirox hydrolacquer), luliconazole 5% solution, and their comparators. Ciclopirox 8% lacquer may increase adverse events (low-quality evidence). High- to moderate-quality evidence suggests increased adverse events with efinaconazole 10% solution or tavaborole 5% solution. We downgraded evidence for heterogeneity, lack of blinding, and small sample sizes. There is uncertainty about the effectiveness of device-based treatments, which were under-represented; 80% of studies assessed topical treatments, but we were unable to evaluate all of the currently relevant topical treatments. Future studies of topical and device-based therapies should be blinded, with patient-centred outcomes and an adequate sample size. They should specify the causative organism and directly compare treatments.
Topics: Administration, Topical; Adult; Aged; Antifungal Agents; Female; Humans; Male; Middle Aged; Onychomycosis; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31978269
DOI: 10.1002/14651858.CD012093.pub2 -
Journal of the European Academy of... Nov 2021Tinea capitis is a fungal infection mostly affecting children. Epidemiology is changing over time due to migration, and it has been estimated that up to 40% of children... (Review)
Review
Tinea capitis is a fungal infection mostly affecting children. Epidemiology is changing over time due to migration, and it has been estimated that up to 40% of children from certain developing countries are affected. The mechanism of transmission is still unclear although asymptomatic carriage seems to have an influence in establishing persistent reservoirs that can cause or fuel epidemics. Screening and prophylactic treatment of close contacts of tinea capitis patients are therefore recommended by several international guidelines, but vaguely and not consistent. The treatments involved can be expensive, hard to integrate in everyday life, have well-known side effects and some are not approved for the treatment of children. The aim of this review was to clarify the evidence behind treatment of human asymptomatic carriers of tinea capitis. Databases were searched for the 'tinea capitis', 'carriers' and 'treatment'. Inclusion criteria were clinical trials, observational and interventional studies including case series (10+ cases) and case reports in English, Danish, Swedish, Norwegian and French. Reviews, guidelines, unclear reports and in vitro trials were excluded. A systematic review identified 10 studies with low to moderate evidence levels. The topical treatments ketoconazole, povidone-iodine, miconazole and the systemic antifungals terbinafine and itraconazole have all shown significant effects in the mycological eradication of fungal conidia. General prophylactic hygienic measures may have a benefit. The scientific evidence behind the treatment of asymptomatic carriage of scalp dermatophytes is sparse and not of high quality. Yet, both topical and systemic antifungal agents show treatment efficacy. Considering the possible adverse effects, topical agents are preferable, but with necessary attention to the compliance of asymptomatic contacts with treatment.
Topics: Antifungal Agents; Child; Humans; Itraconazole; Naphthalenes; Terbinafine; Tinea Capitis
PubMed: 34146430
DOI: 10.1111/jdv.17462 -
Journal of the European Academy of... Jun 2015Onychomycosis is a fungal infection of the nail and is the most common nail affliction in the general population. Certain patient populations are at greater risk of... (Review)
Review
Onychomycosis is a fungal infection of the nail and is the most common nail affliction in the general population. Certain patient populations are at greater risk of infection and the prevalence of onychomycosis reported in the literature has yet to be summarized across these at-risk groups. We performed a systematic review of the literature and calculated pooled prevalence estimates of onychomycosis in at-risk patient populations. The prevalence of dermatophyte toenail onychomycosis was as follows: general population 3.22% (3.07, 3.38), children 0.14% (0.11, 0.18), the elderly 10.28% (8.63, 12.18), diabetic patients 8.75% (7.48, 10.21), psoriatic patients 10.22% (8.61, 12.09), HIV positive patients 10.40% (8.02, 13.38), dialysis patients 11.93% (7.11, 19.35) and renal transplant patients 5.17% (1.77, 14.14). Dialysis patients had the highest prevalence of onychomycosis caused by dermatophytes, elderly individuals had the highest prevalence of onychomycosis caused by yeasts (6.07%; 95% CI = 3.58, 10.11) and psoriatic patients had the highest prevalence of onychomycosis caused by non-dermatophyte moulds (2.49%; 95% CI = 1.74, 3.55). An increased prevalence of onychomycosis in certain patient populations may be attributed to impaired immunity, reduced peripheral circulation and alterations to the nail plate which render these patients more susceptible to infection.
Topics: Age Factors; Arthrodermataceae; Diabetes Mellitus; Foot Dermatoses; HIV Infections; Humans; Kidney Transplantation; Onychomycosis; Prevalence; Psoriasis; Renal Dialysis; Risk Factors; Yeasts
PubMed: 25413984
DOI: 10.1111/jdv.12873 -
The Cochrane Database of Systematic... Jul 2017Fungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment.
OBJECTIVES
To assess the effects of oral antifungal treatments for toenail onychomycosis.
SEARCH METHODS
We searched the following databases up to October 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We sought to identify unpublished and ongoing trials by correspondence with authors and by contacting relevant pharmaceutical companies.
SELECTION CRITERIA
RCTs comparing oral antifungal treatment to placebo or another oral antifungal treatment in participants with toenail onychomycosis, confirmed by one or more positive cultures, direct microscopy of fungal elements, or histological examination of the nail.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included 48 studies involving 10,200 participants. Half the studies took place in more than one centre and were conducted in outpatient dermatology settings. The participants mainly had subungual fungal infection of the toenails. Study duration ranged from 4 months to 2 years.We assessed one study as being at low risk of bias in all domains and 18 studies as being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'.We found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure (risk ratio (RR) 6.00, 95% confidence interval (CI) 3.96 to 9.08, 8 studies, 1006 participants) and mycological cure (RR 4.53, 95% CI 2.47 to 8.33, 8 studies, 1006 participants). Adverse events amongst terbinafine-treated participants included gastrointestinal symptoms, infections, and headache, but there was probably no significant difference in their risk between the groups (RR 1.13, 95% CI 0.87 to 1.47, 4 studies, 399 participants, moderate-quality evidence).There was high-quality evidence that azoles were more effective than placebo for achieving clinical cure (RR 22.18, 95% CI 12.63 to 38.95, 9 studies, 3440 participants) and mycological cure (RR 5.86, 95% CI 3.23 to 10.62, 9 studies, 3440 participants). There were slightly more adverse events in the azole group (the most common being headache, flu-like symptoms, and nausea), but the difference was probably not significant (RR 1.04, 95% CI 0.97 to 1.12; 9 studies, 3441 participants, moderate-quality evidence).Terbinafine and azoles may lower the recurrence rate when compared, individually, to placebo (RR 0.05, 95% CI 0.01 to 0.38, 1 study, 35 participants; RR 0.55, 95% CI 0.29 to 1.07, 1 study, 26 participants, respectively; both low-quality evidence).There is moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure (RR 0.82, 95% CI 0.72 to 0.95, 15 studies, 2168 participants) and mycological cure (RR 0.77, 95% CI 0.68 to 0.88, 17 studies, 2544 participants). There was probably no difference in the risk of adverse events (RR 1.00, 95% CI 0.86 to 1.17; 9 studies, 1762 participants, moderate-quality evidence) between the two groups, and there may be no difference in recurrence rate (RR 1.11, 95% CI 0.68 to 1.79, 5 studies, 282 participants, low-quality evidence). Common adverse events in both groups included headache, viral infection, and nausea.Moderate-quality evidence shows that azoles and griseofulvin probably had similar efficacy for achieving clinical cure (RR 0.94, 95% CI 0.45 to 1.96, 5 studies, 222 participants) and mycological cure (RR 0.87, 95% CI 0.50 to 1.51, 5 studies, 222 participants). However, the risk of adverse events was probably higher in the griseofulvin group (RR 2.41, 95% CI 1.56 to 3.73, 2 studies, 143 participants, moderate-quality evidence), with the most common being gastrointestinal disturbance and allergic reaction (in griseofulvin-treated participants) along with nausea and vomiting (in azole-treated participants). Very low-quality evidence means we are uncertain about this comparison's impact on recurrence rate (RR 4.00, 0.26 to 61.76, 1 study, 7 participants).There is low-quality evidence that terbinafine may be more effective than griseofulvin in terms of clinical cure (RR 0.32, 95% CI 0.14 to 0.72, 4 studies, 270 participants) and mycological cure (RR 0.64, 95% CI 0.46 to 0.90, 5 studies, 465 participants), and griseofulvin was associated with a higher risk of adverse events, although this was based on low-quality evidence (RR 2.09, 95% CI 1.15 to 3.82, 2 studies, 100 participants). Common adverse events included headache and stomach problems (in griseofulvin-treated participants) as well as taste loss and nausea (in terbinafine-treated participants). No studies addressed recurrence rate for this comparison.No study addressed quality of life.
AUTHORS' CONCLUSIONS
We found high-quality evidence that compared to placebo, terbinafine and azoles are effective treatments for the mycological and clinical cure of onychomycosis, with moderate-quality evidence of excess harm. However, terbinafine probably leads to better cure rates than azoles with the same risk of adverse events (moderate-quality evidence).Azole and griseofulvin were shown to probably have a similar effect on cure, but more adverse events appeared to occur with the latter (moderate-quality evidence). Terbinafine may improve cure and be associated with fewer adverse effects when compared to griseofulvin (low-quality evidence).Only four comparisons assessed recurrence rate: low-quality evidence found that terbinafine or azoles may lower the recurrence rate when compared to placebo, but there may be no difference between them.Only a limited number of studies reported adverse events, and the severity of the events was not taken into account.Overall, the quality of the evidence varied widely from high to very low depending on the outcome and comparison. The main reasons to downgrade evidence were limitations in study design, such as unclear allocation concealment and randomisation as well as lack of blinding.
Topics: Administration, Oral; Adult; Aged; Antifungal Agents; Azoles; Female; Foot Dermatoses; Griseofulvin; Humans; Male; Middle Aged; Naphthalenes; Onychomycosis; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Terbinafine
PubMed: 28707751
DOI: 10.1002/14651858.CD010031.pub2 -
Lasers in Medical Science Aug 2022Onychomycosis is a common fungal infection of the nail. Laser and topical antifungal agent combination therapy is an emerging treatment for onychomycosis. The objective... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Onychomycosis is a common fungal infection of the nail. Laser and topical antifungal agent combination therapy is an emerging treatment for onychomycosis. The objective of this study was to systematically evaluate the efficacy and safety of laser and topical antifungal agent combination therapy for onychomycosis.
METHODS
The PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang and VIP databases were searched from inception to November 2021. Randomised controlled trials (RCTs) on laser therapy combined with topical antifungal agents for onychomycosis were included. The Cochrane Collaboration tool was used to assess the risk of bias, and Revman 5.3 software was used in the meta-analysis.
RESULTS
Twelve studies involving 869 patients were included in this meta-analysis. The results showed that compared with topical antifungal agents alone, laser and topical antifungal agent combination therapy was superior in terms of the complete cure rate (RR 6.04,95% CI (2.17, 16.85), P = 0.0006), mycological cure rate (RR 1.27, 95% CI (1.10, 1.48), P = 0.001), clinical effective rate (RR 1.38, 95% CI (1.20, 1.57), P < 0.00001) and patient satisfaction rate (RR 1.47,95% CI (1.17, 1.84), P = 0.0009).The subgroup analysis of outcome indicators, including mycological cure rate and clinical effective rate, demonstrated that both carbon dioxide (CO) laser therapy combined with topical antifungal therapy and 1064-nm neodymium-doped:yttrium aluminium garnet (Nd:YAG) laser therapy combined with topical antifungal therapy showed better results than topical antifungal therapy alone. No adverse events were identified except for three studies reporting transient burning sensation without treatment and mild to moderate pain, both of which were well tolerated.
CONCLUSION
The present study indicated that laser and topical antifungal agent combination therapy is effective for onychomycosis. However, more large-scale and well-designed RCTs are warranted.
Topics: Antifungal Agents; Humans; Laser Therapy; Lasers, Gas; Low-Level Light Therapy; Onychomycosis; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35484440
DOI: 10.1007/s10103-022-03561-9 -
Mycoses Aug 2021Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise... (Review)
Review
BACKGROUND
Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise efficacy data.
OBJECTIVES
We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials.
METHODS
A PubMed search for onychomycosis clinical trials was performed in August 2020. Primary clinical trial data were included and post hoc analyses were excluded. Categorical variables were compared using chi-squared and Fisher's exact tests. Statistical significance was set at p < .05. Photos in articles were categorised by Fitzpatrick skin type.
RESULTS
Only 32/182 (17.5%) trials reported on race and/or ethnicity and only one trial compared treatment efficacy in different subgroups. Darker skin colours were infrequently depicted in articles. Topical treatment, location with ≥1 US-based site, industry funding type and publication date after 2000 were significantly associated with reporting of racial/ethnic data (p < .05 for all comparisons).
LIMITATIONS
Demographics on excluded subjects and methods of recruitment were not available. Assigning Fitzpatrick skin type is inherently subjective.
CONCLUSIONS
This study highlights a need for consistent reporting of races and ethnicities of onychomycosis clinical trial participants with subgroup analyses of treatment efficacies.
Topics: Administration, Topical; Antifungal Agents; Clinical Trials as Topic; Foot Dermatoses; Humans; Onychomycosis; Treatment Outcome
PubMed: 33655595
DOI: 10.1111/myc.13262 -
Photobiomodulation, Photomedicine, and... Feb 2023The purpose of this study is to evaluate the effectiveness and safety of photodynamic therapy (PDT) in treating superficial fungal infections, and provide reference for... (Meta-Analysis)
Meta-Analysis Review
The purpose of this study is to evaluate the effectiveness and safety of photodynamic therapy (PDT) in treating superficial fungal infections, and provide reference for clinical application. In accordance with Population, Intervention, Comparator, and Outcome (PICO), the research question and keywords were formulated. Records published in English by PubMed, Embase, Cochrane Library, and Web of Science as of November 14, 2022 were retrieved, including the keywords "mycoses," "tinea," "photochemotherapy," etc. Besides, meta-analysis performed by STATA and PROSPERO registration code was CRD42022363448. One thousand four hundred eighty-four records were identified and 18 articles involving 343 patients with superficial fungal infections were enrolled. The overall mycological cure rate of PDT is 55% [95% confidence interval (CI): 0.46-0.65]. The fungal cure rate using methylene blue (MB) as photosensitizer (PS) is 67% (95% CI: 0.55-0.79); using 5-aminolevulinic acid is 34% (95% CI: 0.21-0.47); and using methyl aminolevulinate is 56% (95% CI: 0.33-0.78). The fungal cure rate of moderate-to-severe onychomycosis according to Onychomycosis Severity Index is 60% (95% CI: 0.47-0.73) and that of moderate onychomycosis is 66% (95% CI: 0.56-0.76). It was observed that the treatment parameters did not follow the same standard across studies. The majority of the included studies were moderate to low biased. PDT, particularly using MB as PS, has a certain mycological cure rate and safety at treating superficial mycoses. Due to the insufficient number of studies on PDT in the treatment of superficial fungal infections and the small sample size of some studies, more studies with standardized PDT parameters, large sample size, and long follow-up periods are needed to prove that PDT has the potential to become an alternative to traditional antifungal therapy or to find a better combination between them.
Topics: Humans; Onychomycosis; Photosensitizing Agents; Photochemotherapy; Antifungal Agents; Ultraviolet Therapy
PubMed: 36780576
DOI: 10.1089/photob.2022.0117