Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study

Gupta, Aditya K.; Surprenant, Maria S.; Kempers, Steven; Pariser, David M.; Rensfeldt, Kjell; Tavakkol, Amir

doi:10.1016/j.jaad.2020.06.055

Cited by 18 publications

(11 citation statements)

References 18 publications

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“…Gregoriou went on to discuss the results of a multicentre Phase III randomised controlled trial evaluating the efficacy of a 48-week course of terbinafine 10% solution in patients with mild-to-moderate, dermatophyte-positive DLSO, affecting 20 -60% of at least one great toenail, in achieving mycological and complete cure. 2 Upon completion of the 48-week course and 4-week follow-up, 4.5% achieved complete cure compared with 0% in the control group. Furthermore, 69.9% achieved mycological cure compared with 27.7% in the control group The cohort randomised to the terbinafine solution experienced negative fungal culture in 95.5% compared with 58.0% in the control group.…”

Section: Topical Treatment Updatesmentioning

confidence: 92%

“…By Week 52, ≤10% of the target toenail was affected in 19.1% of the terbinafine solution group compared with 8.4% in the control group. 2 No additional adverse events were observed with the terbinafine solution, demonstrating that terbinafine can reach sufficient concentrations in both the nail bed and plate to impose fungicidal activity. 2 Gregoriou commented how he hopes this treatment "will eventually be launched in Europe.…”

Section: Topical Treatment Updatesmentioning

confidence: 93%

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Updates on Best Practices for Onychomycosis: Hitting the Nail on the Head

Richards¹

2022

EMJ Dermatol

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DURING the 31st Annual European Academy of Dermatology and Venereology (EADV) Congress, 7th–10th September 2022, held both in-person in Milan, Italy, and virtually, experts delivered a session on the topic of nail disorders. The session, chaired by Michela Starace, University of Bologna, Italy, and Stamatis Gregoriou, National and Kapodistrian University of Athens, Greece, explored the complexity of nail disease and anatomy, the impact of diet on nail health, nail disorders in childhood, and fungal nail infections. Gregoriou delivered an insightful, up-to-date talk on the best practices for management of distal lateral subungual onychomycosis (DLSO), supported by recent data from clinical studies and the European Nail Society (ENS).1

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Section: Topical Treatment Updatesmentioning

confidence: 92%

Section: Topical Treatment Updatesmentioning

confidence: 93%

Updates on Best Practices for Onychomycosis: Hitting the Nail on the Head

Richards¹

2022

EMJ Dermatol

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“…Novel topical formulations for onychomycosis as alternatives to traditional topical treatments have been of recent interest. In a phase III, multicenter, randomized, double-blind study, 163 365 patients (ages 12–74) with 20–60% distal and lateral subungual onychomycosis of at least one toenail received a once daily application of topical terbinafine (MOB-015 formulation) or matching vehicle for 48 weeks. At week 52, mycologic and complete cure were higher in the MOB-015 (69.9%, 4.5%, respectively) vs vehicle (27.7%, 0%, respectively) groups (p < 0.001, p = 0.0195, respectively).…”

Section: Topical Therapiesmentioning

confidence: 99%

Updated Perspectives on the Diagnosis and Management of Onychomycosis

Falotico¹,

Lipner²

2022

CCID

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Onychomycosis is the most common nail disease encountered in clinical practice and can cause pain, difficulty with ambulation, and psycho-social problems. A thorough history and physical examination, including dermoscopy, should be performed for each patient presenting with nail findings suggestive of onychomycosis. Several approaches are available for definitive diagnostic testing, including potassium hydroxide and microscopy, fungal culture, histopathology, polymerase chain reaction, or a combination of techniques. Confirmatory testing should be performed for each patient prior to initiating any antifungal therapies. There are several different therapeutic options available, including oral and topical medications as well as device-based treatments. Oral antifungals are generally recommended for moderate to severe onychomycosis and have higher cure rates, while topical antifungals are recommended for mild to moderate disease and have more favorable safety profiles. Oral terbinafine, itraconazole, and griseofulvin and topical ciclopirox 8% nail lacquer, efinaconazole 10% solution, and tavaborole 5% solution are approved by the Food and Drug Administration for treatment of onychomycosis in the United States and amorolfine 5% nail lacquer is approved in Europe. Laser treatment is approved in the United States for temporary increases in clear nail, but clinical results are suboptimal. Oral fluconazole is not approved in the United States for onychomycosis treatment, but is frequently used off-label with good efficacy. Several novel oral, topical, and over-the-counter therapies are currently under investigation. Physicians should consider the disease severity, infecting pathogen, medication safety, efficacy and cost, and patient age, comorbidities, medication history, and likelihood of compliance when determining management plans. Onychomycosis is a chronic disease with high recurrence rates and patients should be counseled on an appropriate plan to minimize recurrence risk following effective antifungal therapy.

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“…The mycological cure was measured at week 60 after a 48-week regimen with daily applications and was reported negative in 54.2% of the patients who completed the trial. In a phase III study [ 22 ], patients 12–75 years old with distal subungual onychomycosis (dermatophyte infection previously confirmed by a positive culture) involving 20–60% of at least one great toenail were enrolled. The mycological cure rates at week 52 were 69.9% and 27.7% for MOB015B subjects and the vehicle group, respectively ( p < 0.001).…”

Section: Topical Antifungal Nail Therapies Under Development and Inve...mentioning

confidence: 99%

Novel and Investigational Treatments for Onychomycosis

Gregoriou

Kyriazopoulou

Tsiogka

et al. 2022

JoF

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Onychomycosis is a common nail disease caused by fungi. The primary pathogens are dermatophytes; however, yeasts, non-dermatophyte moulds, and mixed fungal populations may also contribute to the development of a recalcitrant condition, usually accompanied by difficulties in everyday life and severe emotional stress. Treatment failure and relapse of the infection are the most frequent problems, though new issues have become the new challenges in the therapeutic approach to onychomycosis. Resistance to antifungals, an increasing number of comorbidities, and polydrug use among the ageing population are imperatives that impose a shift to safer drugs. Topical antifungals are considered less toxic and minimally interact with other drugs. The development of new topical drugs for onychomycosis is driven by the unmet need for effective agents with prolonged post-treatment disease-free time and a lack of systemic impact on the patients’ health. Efinaconazole, Tavaborole, and Luliconazole have been added to physicians’ weaponry during the last decade, though launched on the market of a limited number of countries. The pipeline is either developing new products (e.g., ME-1111 and NP213) with an appealing combination of pharmacokinetic, efficacy, and safety properties or reformulating old, well-known drugs (Terbinafine and Amphotericin B) by using new excipients as penetration enhancers.

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Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study

Cited by 18 publications

References 18 publications

Updates on Best Practices for Onychomycosis: Hitting the Nail on the Head

Updates on Best Practices for Onychomycosis: Hitting the Nail on the Head

Updated Perspectives on the Diagnosis and Management of Onychomycosis

Novel and Investigational Treatments for Onychomycosis

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