Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox

Official title

Retrospective Observational Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox

Overview

The goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or Mycoclear®, in treating fungal infections. People with fungal infections of the nails and over the age of 18 were treated at the Department of Dermatology, IRCCS Azienda Ospedaliero - Universitaria Sant'Orsola in Bologna (Italy) between January 1, 2019, and April 30, 2023. The people were treated as part of their regular medical care with ciclopirox or Mycoclear®. In this observational study, the data are now being reviewed to answer the following questions: • Does Mycoclear® work as well as ciclopirox for fungal nail infections, when used for up to 24 weeks? People were seen at the beginning for an initial assessment, and then again at two, four, 12, and 24 weeks. The doctor did the following main tests during the study period: * Performing the clinical evaluation * Checking the lab test for a fungal infection. * Measuring how much of the nail grows without problems. The results of this study will help dermatologists choose the best treatment for fungal nail infections.

Detailed description

In Italy the prevalence of onychomycosis in subjects aged \>65 years was as high as 35%. This observational, retrospective study has the objective to evaluate the safety and effectiveness of two treatment for distal and lateral subungual onychomycosis (DLSO), the most prevalent clinical variant of onychomycosis. Two cohorts of patients treated between January 2019, and April 2023 are involved: 40 patients treated with Mycoclear, a medical device that is widely used as an antifungal in outpatient clinical practice and 40 patients treated with ciclopirox, an commonly used antifungal drug. The primary outcomes are the Investigator Global Assessment of Efficacy, mycological assessment, and the extent of healthy nail growth. Safety is evaluated by the incidence of adverse events. Patients were treated for a maximum period of 24 weeks, in accordance with the "standard usual care" of the center and were visited at baseline, week two, four, 12, and 24 (final visit).

Primary outcome measures

• Investigator Global Assessment of Efficacy [Time frame: 24 weeks]
• Mycological assessment [Time frame: 24 weeks]

Secondary outcome measures (3)

• Patient Global Assessment of Efficacy [Time frame: 24 weeks]
• Patient Assessment of Usability [Time frame: 24 weeks]
• Incidence of adverse events [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years old.
• Patients clinically and microscopically KOH diagnosed with distal and lateral subungual onychomycosis (DLSO) (≤30% involvement of the nail plate of at least one of the great toenails) and evaluated as mild to moderate following OSI6.
• Patients presenting positive direct potassium hydroxide (KOH) microscopy and positive fungal culture for dermatophytes

Exclusion criteria

• Other types of onychomycoses.
• Subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening.
• Pregnant woman, lactating woman.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• UOC di Dermatologia - IRCCS Policlinico di Sant'Orsola - Università di Bologna — Bologna

Publications

• Shemer A, Nathansohn N, Trau H, Amichai B, Grunwald MH. Ciclopirox nail lacquer for the treatment of onychomycosis: an open non-comparative study. J Dermatol. 2010 Feb;37(2):137-9. doi: 10.1111/j.1346-8138.2009.00773.x. PMID 20175847
• Carney C, Tosti A, Daniel R, Scher R, Rich P, DeCoster J, Elewski B. A new classification system for grading the severity of onychomycosis: Onychomycosis Severity Index. Arch Dermatol. 2011 Nov;147(11):1277-82. doi: 10.1001/archdermatol.2011.267. PMID 22106113
• Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5. PMID 33947295
• Yadav P, Singal A, Pandhi D, Das S. Comparative efficacy of continuous and pulse dose terbinafine regimes in toenail dermatophytosis: A randomized double-blind trial. Indian J Dermatol Venereol Leprol. 2015 Jul-Aug;81(4):363-9. doi: 10.4103/0378-6323.158634. PMID 26087080
• Arenas R. [Onychomycosis. Clinico-epidemiological mycological and therapeutic aspects]. Gac Med Mex. 1990 Mar-Apr;126(2):84-9; discussion 90-1. Spanish. PMID 2143740
• Naeimifar A, Samadi A, Ahmad Nasrollahi S, Fattahi A, Ghasemi Z, Azizzadeh-Roodpishi S, Malakooti S, Ehsani AH, Firooz A, Dowlatiy Y. Efinaconazole topical solution 10%: Formulation and efficacy assessment in the treatment of toenail onychomycosis. Mycoses. 2020 May;63(5):517-524. doi: 10.1111/myc.13062. Epub 2020 Mar 6. PMID 32048351
• Piraccini BM, Starace M, Toft A. Early Visible Improvements during K101-03 Treatment: An Open-Label Multicenter Clinical Investigation in Patients with Onychomycosis and/or Nail Psoriasis. Dermatology. 2017;233(2-3):178-183. doi: 10.1159/000478257. Epub 2017 Aug 5. PMID 28787710
• Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000 Oct;43(4 Suppl):S70-80. doi: 10.1067/mjd.2000.109071. PMID 11051136

Identifiers

NCT: NCT06971341 · ONYCO/23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗