Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
NCT ID: NCT06971341
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2025-05-30
2025-12-30
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Mycoclear®, medical device as antimycotic topical solution
Mycoclear® was topically administered as indicated in the instructions for use of the product for a maximum of 24 weeks
No interventions assigned to this group
Ciclopirox, antimycotic drug
Ciclopirox was topically administered as indicated in the instructions for use of the product for a maximum of 24 weeks
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening.
* Pregnant woman, lactating woman.
18 Years
ALL
No
Sponsors
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Dionisio Franco Barattini, MD, MBA, MSc
UNKNOWN
University of Bologna
OTHER
Responsible Party
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Michela Valeria Rita Starace, MD PhD
Full-time Researcher RTD-B
Principal Investigators
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Bianca M Piraccini, Prof PhD MD
Role: STUDY_DIRECTOR
Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum - Università di Bologna
Locations
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UOC di Dermatologia - IRCCS Policlinico di Sant'Orsola - Università di Bologna
Bologna, BO, Italy
Countries
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Central Contacts
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Lucia A Data Manager, Msc
Role: CONTACT
Facility Contacts
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References
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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.
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.
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.
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.
Arenas R. [Onychomycosis. Clinico-epidemiological mycological and therapeutic aspects]. Gac Med Mex. 1990 Mar-Apr;126(2):84-9; discussion 90-1. Spanish.
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.
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.
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.
Ricardo JW, Lipner SR. Safety of current therapies for onychomycosis. Expert Opin Drug Saf. 2020 Nov;19(11):1395-1408. doi: 10.1080/14740338.2020.1829592. Epub 2020 Oct 12.
Piraccini BM, Iorizzo M, Lencastre A, Nenoff P, Rigopoulos D. Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer: A Review of Its Use in Onychomycosis. Dermatol Ther (Heidelb). 2020 Oct;10(5):917-929. doi: 10.1007/s13555-020-00420-9. Epub 2020 Jul 23.
Piraccini BM, Starace M, Rubin AI, Di Chiacchio NG, Iorizzo M, Rigopoulos D; A working group of the European Nail Society. Onychomycosis: Recommendations for Diagnosis, Assessment of Treatment Efficacy, and Specialist Referral. The CONSONANCE Consensus Project. Dermatol Ther (Heidelb). 2022 Apr;12(4):885-898. doi: 10.1007/s13555-022-00698-x. Epub 2022 Mar 9.
Maggioni D, Cimicata A, Pratico A, Villa R, Bianchi F, Badiale SB, Piana U, Angelinetta C. Clinical Evaluation of a Topical Formulation for the Management of Onychomycosis. J Clin Aesthet Dermatol. 2020 Jul;13(7):53-57. Epub 2020 Jul 1.
Lipner SR, Scher RK. Onychomycosis: Treatment and prevention of recurrence. J Am Acad Dermatol. 2019 Apr;80(4):853-867. doi: 10.1016/j.jaad.2018.05.1260. Epub 2018 Jun 28.
Nenoff P, Reinel D, Mayser P, Abeck D, Bezold G, Bosshard PP, Brasch J, Daeschlein G, Effendy I, Ginter-Hanselmayer G, Graser Y, Hamm G, Hengge U, Hipler UC, Hoger P, Kargl A, Kolb-Maurer A, Kruger C, Malisiewicz B, Mayer J, Ott H, Paasch U, Schaller M, Uhrlass S, Zidane M. S1 Guideline onychomycosis. J Dtsch Dermatol Ges. 2023 Jun;21(6):678-692. doi: 10.1111/ddg.14988. Epub 2023 May 22.
Maskan Bermudez N, Rodriguez-Tamez G, Perez S, Tosti A. Onychomycosis: Old and New. J Fungi (Basel). 2023 May 12;9(5):559. doi: 10.3390/jof9050559.
Leung AKC, Lam JM, Leong KF, Hon KL, Barankin B, Leung AAM, Wong AHC. Onychomycosis: An Updated Review. Recent Pat Inflamm Allergy Drug Discov. 2020;14(1):32-45. doi: 10.2174/1872213X13666191026090713.
Cozzani E, Agnoletti AF, Speziari S, Schiavetti I, Zotti M, Persi A, Drago F, Parodi A. Epidemiological study of onychomycosis in older adults with onychodystrophy. Geriatr Gerontol Int. 2016 Apr;16(4):486-91. doi: 10.1111/ggi.12496. Epub 2015 May 15.
Heikkila H, Stubb S. The prevalence of onychomycosis in Finland. Br J Dermatol. 1995 Nov;133(5):699-703. doi: 10.1111/j.1365-2133.1995.tb02741.x.
Sigurgeirsson B, Baran R. The prevalence of onychomycosis in the global population: a literature study. J Eur Acad Dermatol Venereol. 2014 Nov;28(11):1480-91. doi: 10.1111/jdv.12323. Epub 2013 Nov 28.
Other Identifiers
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ONYCO/23
Identifier Type: -
Identifier Source: org_study_id
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