OnychomycosisPhase 4LaserNCT05809297
Diode Laser and Photodynamic Therapy Vs. Ciclopirox.
A Phase 4 study testing Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® and Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer in people with Onychomycosis, run by Universidad Complutense de Madrid.
Trial summary
The main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer. The study is a low-intervention, randomised controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® and Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
- Patients over 18 years of age.
Who cannot join
- Patients who have received topical or systemic antifungal treatment in the previous month.
- Pregnancy or lactation.
- Patients with peripheral vascular disease.
- Patients with an immune system disorder or undergoing treatment with immunosuppressants.
- Patients with peripheral or central neuropathy.
- Patients with a coagulation disorder.
- Patients with Raynaud's disease or with any alteration in the perception of cold or heat.
Trial locations and contacts
No sites are listed yet.
Francisco Javier Álvaro Afonso, PhD contact
About this study
Official title: Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.
The main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
The study is a low-intervention, randomised controlled clinical trial. Patient recruitment will be done by including in the sample those patients who have diagnostic confirmation of onychomycosis in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid. Participants in the trial will be assigned with equal probability to each treatment arm, according to their consecutive inclusion in the study. Subsequently, treatment assignment will be determined by a random code. The treatment used will be evident to both the participant and the podiatrist responsible for the intervention.
Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
Read the detailed description
Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
- Conditions
- Onychomycosis
- Being tested
- Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®, Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
- Keywords
- onychomycosis, laser, ciclopirox
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®Device
Also called Laser
According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.
Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail LacquerDrug
Also called Control
The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.
| Study group | Role | What they receive |
|---|---|---|
| Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY) | Experimental | According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist. Receives: Device: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® |
| Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer | Active comparator | The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day. Receives: Drug: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Clinical cure (yes/no).
Measured: 12 months
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Mycological cure (yes/no)
Measured: 12 months
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Complete cure (yes/no)
Measured: 12 months
Secondary outcomes (6)
To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve clinical cure of onychomycosis.
Clinical cure (yes/no)
Measured: 12 months
To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve, mycological cure of onychomycosis.
Mycological cure (yes/no).
Measured: 12 months
To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve complete cure of onychomycosis.
Complete cure (yes/no).
Measured: 12 months
To analyse the influence of the type of onychomycosis on the response to treatment.
Onychomycosis clasification (ODL, total dystrophic, superficial)
Measured: 12 months
To analyse the influence of the causal fungal agent on the response to treatment.
Causal fungal agent (dermatophyte, mould or yeast)
Measured: 12 months
To analyse the influence of the degree of severity of onychomycosis on the response to treatment.
Onychomycosis severity index (OSI)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FRANCISCO JAVIER ALVARO AFONSO, Universidad Complutense de Madrid
- Investigators
- Francisco Javier Álvaro Afonso, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809297
- Sponsor's protocol ID
- Nº EudraCT 2022-003913-12
- Acronym
- Laser
- Status last verified
- May 2023
- First submitted
- 15 Mar 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Garcia-Oreja S, Alvaro-Afonso FJ, Navarro-Perez D, Leon-Herce D, Tardaguila-Garcia A, Lazaro-Martinez JL. Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial. Mycoses. 2025 Oct;68(10):e70121. doi: 10.1111/myc.70121.
PubMed 41024682
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05809297
- Acronym / sponsor ID
- Laser / Nº EudraCT 2022-003913-12
- Conditions
- Onychomycosis
- Keywords
- onychomycosis, laser, ciclopirox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 2023 (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 main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
The study is a low-intervention, randomised controlled clinical trial. Patient recruitment will be done by including in the sample those patients who have diagnostic confirmation of onychomycosis in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid. Participants in the trial will be assigned with equal probability to each treatment arm, according to their consecutive inclusion in the study. Subsequently, treatment assignment will be determined by a random code. The treatment used will be evident to both the participant and the podiatrist responsible for the intervention.
Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
Detailed description
Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY) | Experimental | Device: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist. |
| Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer | Active comparator | Drug: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail LacquerThe application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
- Patients over 18 years of age.
Key exclusion criteria (7 listed)
- Patients who have received topical or systemic antifungal treatment in the previous month.
- Pregnancy or lactation.
- Patients with peripheral vascular disease.
- Patients with an immune system disorder or undergoing treatment with immunosuppressants.
- Patients with peripheral or central neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®Also: LaserAccording to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist. | Device | Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY) |
| Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail LacquerAlso: ControlThe application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day. | Drug | Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer |
Primary outcome
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Time frame: 12 months
Clinical cure (yes/no).
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Time frame: 12 months
Mycological cure (yes/no)
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Time frame: 12 months
Complete cure (yes/no)
6 secondary outcomes
To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve clinical cure of onychomycosis.
Time frame: 12 months
To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve, mycological cure of onychomycosis.
Time frame: 12 months
To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve complete cure of onychomycosis.
Time frame: 12 months
To analyse the influence of the type of onychomycosis on the response to treatment.
Time frame: 12 months
To analyse the influence of the causal fungal agent on the response to treatment.
Time frame: 12 months
To analyse the influence of the degree of severity of onychomycosis on the response to treatment.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 41024682Garcia-Oreja S, Alvaro-Afonso FJ, Navarro-Perez D, Leon-Herce D, Tardaguila-Garcia A, Lazaro-Martinez JL. Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial. Mycoses. 2025 Oct;68(10):e70121. doi: 10.1111/myc.70121.
- Individual participant dataSharing planned: No
Related trials for Onychomycosis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
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. This study is not recruiting at the moment.
Francisco Javier Álvaro Afonso, PhD contact
Francisco Javier Álvaro Afonso principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® and Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer in people with Onychomycosis, run by Universidad Complutense de Madrid.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier Álvaro Afonso, PhD (91 394 1535, alvaro@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer. (time frame: 12 months). The study lists 3 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 NCT05809297, which also lists 1 linked publication.
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 10 May 2023.