Dermatologic DiseaseNCT06485050
Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes.
A study testing Photodynamic therapy in people with Dermatologic Disease and Onychomycosis of Toenail, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
There are different therapeutic alternatives for onychomycosis. Systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatologic Disease, Onychomycosis of Toenail, Diabetic Foot
- What is being tested?
- Photodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- 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 with diabetes 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University podiatry clinic (Complutense University of Madrid)
Madrid, 28040
About this study
Official title: Photodynamic Therapy as Adjuvant Therapy to Topical Antifungal Treatments for Onychomycosis in Patients With Diabetes. A Prospective Case Series.
There are different therapeutic alternatives for onychomycosis. Systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than five drugs is not recommended even though these individuals are at serious risk of fungal infection. On the other hand, laser therapy would be contraindicated in patients with neuropathy or peripheral vascular disease (diabetic foot patients) because of possible burns. Topical antifungals or lacquers are associated with a low risk of systemic adverse events and drug-drug interactions and would therefore be the most appropriate treatment for patients with diabetic foot. However, they require very long treatment periods, are generally applied daily for 12 months to allow the normal nail to grow and replace the regions damaged by the infection and have a lower cure rate.
Because of all the above difficulties, there is a need to augment topical treatments in routine clinical practice with adjunctive therapies such as photodynamic therapy for the treatment of onychomycosis in patients with diabetes.
Read more
The main aim of this study is to observe the effectiveness and safety of the combination of photodynamic therapy with the usual antifungal treatment in consultation in patients with diabetes. Secondary aims have been defined as follows:
To determine whether 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis; And to analyse the influence of the type of onychomycosis (ODL, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (through the OSI) on the response to treatment.
Patients included in the study will be visited every 2 weeks during the first two months, applying photodynamic therapy during visits 2, 3 and 4. Subsequently, a check-up will be performed two weeks after the last application of photodynamic therapy and monthly visits for the remainder of the study. At each visit and at subsequent check-ups, the nail plate and peri- and subungual hyperkeratotic tissue will be debrided and reamed in order to improve the effects of the treatment.
- Being tested
- Photodynamic therapy
- Medical subject headings
- Skin Diseases, Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyCombination product
Application of red laser-photodynamic therapy using "Rapid Podia" Laser diode® (MEDENCY). The following protocol will be followed: 1) mechanical debridement of the nail, 2) disinfection of the nail with alcohol, 3) application of topical photosensitiser (Toluidine blue gel) for 5 minutes with the area covered, 5) application of 635 nm diode laser for 10 minutes.
Daily application of ciclopirox 8% with ethyl acetate, ethanol (96%), ketosteryl alcohol, hydroxypropyl chitosan and purified water.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy with ciclopirox 8% | Experimental | Not described Receives: Combination Product: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome
Number of participants with treatment-related adverse events as assessed by the effectiveness of the combination of photodynamic therapy with the usual antifungal treatment in the clinic in patients with diabetes, change from baseline in score on the Onychomycosis Severity Index (OSI), microbiological culture and polymerase chain reaction (PCR) at 6 months.
Measured: 6 months
Secondary outcomes (3)
Secondary outcome
Number of patients who are successfully cured with 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis with microbiological culture and PCR results.
Measured: 6 months
Secondary outcome
Influence of the type of onychomycosis (ODL, total dystrophic, superficial) and the degree of severity of onychomycosis by the OSI score on the response to treatment at 6 months.
Measured: 6 months
Secondary outcome
Influence of the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis by the OSI score on the response to treatment at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start17 Apr 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Lazaro Martinez, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485050
- Sponsor's protocol ID
- 24/241-E
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy as Adjuvant Therapy to Topical Antifungal Treatments for Onychomycosis in Patients With Diabetes. A Prospective Case Series.
- ClinicalTrials.gov ID
- NCT06485050
- Acronym / sponsor ID
- 24/241-E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
There are different therapeutic alternatives for onychomycosis. Systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than five drugs is not recommended even though these individuals are at serious risk of fungal infection. On the other hand, laser therapy would be contraindicated in patients with neuropathy or peripheral vascular disease (diabetic foot patients) because of possible burns. Topical antifungals or lacquers are associated with a low risk of systemic adverse events and drug-drug interactions and would therefore be the most appropriate treatment for patients with diabetic foot. However, they require very long treatment periods, are generally applied daily for 12 months to allow the normal nail to grow and replace the regions damaged by the infection and have a lower cure rate.
Because of all the above difficulties, there is a need to augment topical treatments in routine clinical practice with adjunctive therapies such as photodynamic therapy for the treatment of onychomycosis in patients with diabetes.
The main aim of this study is to observe the effectiveness and safety of the combination of photodynamic therapy with the usual antifungal treatment in consultation in patients with diabetes. Secondary aims have been defined as follows:
To determine whether 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis; And to analyse the influence of the type of onychomycosis (ODL, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (through the OSI) on the response to treatment.
Patients included in the study will be visited every 2 weeks during the first two months, applying photodynamic therapy during visits 2, 3 and 4. Subsequently, a check-up will be performed two weeks after the last application of photodynamic therapy and monthly visits for the remainder of the study. At each visit and at subsequent check-ups, the nail plate and peri- and subungual hyperkeratotic tissue will be debrided and reamed in order to improve the effects of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy with ciclopirox 8% | Experimental | Combination Product: Photodynamic therapy |
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 with diabetes diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
- Patients over 18 years of age.
Key exclusion criteria (1 listed)
- Patients who have received topical or systemic antifungal treatment in the previous month.
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 |
|---|---|---|
| Photodynamic therapyApplication of red laser-photodynamic therapy using "Rapid Podia" Laser diode® (MEDENCY). The following protocol will be followed: 1) mechanical debridement of the nail, 2) disinfection of the nail with alcohol, 3) application of topical photosensitiser (Toluidine blue gel) for 5 minutes with the area covered, 5) application of 635 nm diode laser for 10 minutes. Daily application of ciclopirox 8% with ethyl acetate, ethanol (96%), ketosteryl alcohol, hydroxypropyl chitosan and purified water. | Combination product | Photodynamic therapy with ciclopirox 8% |
Primary outcome
Main outcome
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by the effectiveness of the combination of photodynamic therapy with the usual antifungal treatment in the clinic in patients with diabetes, change from baseline in score on the Onychomycosis Severity Index (OSI), microbiological culture and polymerase chain reaction (PCR) at 6 months.
3 secondary outcomes
Secondary outcome
Time frame: 6 months
Secondary outcome
Time frame: 6 months
Secondary outcome
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic therapy in people with Dermatologic Disease and Onychomycosis of Toenail, run by Universidad Complutense de Madrid at 1 site in Spain.
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 1 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 3 Jul 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.