Onychomycosis of ToenailsNCT06971341
Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
An observational study of Onychomycosis of Toenails, run by University of Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenails
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucia A Data Manager, Msc contact
Italy1 site
UOC di Dermatologia - IRCCS Policlinico di Sant'Orsola - Università di Bologna
Bologna, BO, 40138
Lucia Abitante, MSc, +39 0512143507, lucia.abitante2@unibo.it
Michela Valeria R Starace, PhD MD
About this study
Official title: Retrospective Observational Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
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?
Read more
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.
Read the 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).
- Conditions
- Onychomycosis of Toenails
- Keywords
- onychomycosis, medical device, observational study
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (3)
Patient Global Assessment of Efficacy
Change from baseline to the final 24 week visit of global treatment effectiveness assessed by the patient and scored by a ordinal scale as follows : 0=no change; 1=moderate improvement; 2=good improvement; 3=excellent improvement.
Measured: 24 weeks
Patient Assessment of Usability
The patient responds to a usability questionnaire for the tested medical device. The questionnaire items will be scored by an ordinal scale (ranging from 1-10) where 1 = poor rating, and 10 = excellent rating)
Measured: 24 weeks
Incidence of adverse events
The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) for the two products will be collected by Investigators only if they were not reported as part of clinical practice in the previous visits performed on the patients.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Onychomycosis of ToenailsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Dionisio Franco Barattini, MD, MBA, MSc
- Responsible party
- Principal investigator, Michela Valeria Rita Starace, MD PhD, University of Bologna
- Investigators
- Bianca M Piraccini, Prof PhD MD, Study director, Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum - Università di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971341
- Sponsor's protocol ID
- ONYCO/23
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 20175847Carney 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.
PubMed 22106113Blauvelt 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.
PubMed 33947295Yadav 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.
PubMed 26087080Arenas R. [Onychomycosis. Clinico-epidemiological mycological and therapeutic aspects]. Gac Med Mex. 1990 Mar-Apr;126(2):84-9; discussion 90-1. Spanish.
PubMed 2143740Naeimifar 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.
PubMed 32048351Piraccini 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.
PubMed 28787710Gupta 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.
PubMed 11051136Ricardo 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.
PubMed 32990062Piraccini 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.
PubMed 32705532Piraccini 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.
PubMed 35262878Maggioni 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.
PubMed 32983339Lipner 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.
PubMed 29959962Nenoff 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.
PubMed 37212291Maskan 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.
PubMed 37233270
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
- ClinicalTrials.gov ID
- NCT06971341
- Acronym / sponsor ID
- ONYCO/23
- Conditions
- Onychomycosis of Toenails
- Keywords
- onychomycosis, medical device, observational study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- Dionisio Franco Barattini, MD, MBA, MSc
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigator Global Assessment of Efficacy
Time frame: 24 weeks
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.
Mycological assessment
Time frame: 24 weeks
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Background: PubMed 20175847Shemer 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.
- Background: PubMed 22106113Carney 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.
- Background: PubMed 33947295Blauvelt 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.
- Background: PubMed 26087080Yadav 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.
- Background: PubMed 2143740Arenas R. [Onychomycosis. Clinico-epidemiological mycological and therapeutic aspects]. Gac Med Mex. 1990 Mar-Apr;126(2):84-9; discussion 90-1. Spanish.
- Background: PubMed 32048351Naeimifar 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.
- Background: PubMed 28787710Piraccini 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.
- Background: PubMed 11051136Gupta 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.
- Background: PubMed 32990062Ricardo 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.
- Background: PubMed 32705532Piraccini 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.
- Background: PubMed 35262878Piraccini 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.
- Background: PubMed 32983339Maggioni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucia A Data Manager, Msc contact
Bianca M Piraccini, Prof PhD MD study director
Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum - Università di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onychomycosis of Toenails, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michela Valeria R Starace, MD PhD (+39 051214 3677, michela.starace2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment of Efficacy (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971341, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.