Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox

NCT06971341 | Not Yet Recruiting

• 1 other identifier: ONYCO/23
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Onychomycosis of Toenails

Keywords

onychomycosis; medical device; observational study

Outcome Measures

Primary Outcomes (2)

• Investigator Global Assessment of Efficacy

  Change from baseline to 24 weeks of nail color, surface, and thickness assessed by the Investigator during the medical examinations and scored by a ordinal scale as follows : 0=no change; 1=moderate improvement; 2=excellent improvement.

  24 weeks

• Mycological assessment

  It was assessed by Investigator during the medical examination by KOH staining and collection of a sample for culture. It was scored according the following: negative culture=cure; positive culture=failure.

  24 weeks

Secondary Outcomes (3)

• Patient Global Assessment of Efficacy

  24 weeks

• Patient Assessment of Usability

  24 weeks

• Incidence of adverse events

  24 weeks

Study Arms (2)

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

Ciclopirox, antimycotic drug

Ciclopirox was topically administered as indicated in the instructions for use of the product for a maximum of 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal outpatients affected by distal and lateral subungual onychomycosis (DLSO) and visited in the Department of Dermatology at the IRCCS Azienda Ospedaliero-Universitaria Sant'Orsola in Bologna, Italy, between January 1, 2019, and April 30, 2023

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead
• Dionisio Franco Barattini, MD, MBA, MSc: collaborator

Study Sites (1)

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

Bologna, BO, 40138, Italy

Location

Related Publications (19)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32990062 BACKGROUND

• 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.

  PMID: 32705532 BACKGROUND

• 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.

  PMID: 35262878 BACKGROUND

• 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.

  PMID: 32983339 BACKGROUND

• 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.

  PMID: 29959962 BACKGROUND

• 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.

  PMID: 37212291 BACKGROUND

• 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.

  PMID: 37233270 BACKGROUND

• 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.

  PMID: 31738146 BACKGROUND

• 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.

  PMID: 25981058 BACKGROUND

• 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.

  PMID: 8555019 BACKGROUND

• 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.

  PMID: 24283696 BACKGROUND

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bianca M Piraccini, Prof PhD MD

  Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum - Università di Bologna

  STUDY DIRECTOR

Central Study Contacts

Michela Valeria R Starace, MD PhD

CONTACT

+39 051214 3677; michela.starace2@unibo.it

Lucia A Data Manager, Msc

CONTACT

+39 0512143507

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time Researcher RTD-B

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

IT (1)