Toenail OnychomycosisNCT03022903
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
A study testing Aminolevulinic Acid (ALA) in people with Toenail Onychomycosis and Distal and Lateral Subungual Toenail Onychomycosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Toenail Onychomycosis, Distal and Lateral Subungual Toenail Onychomycosis
- What is being tested?
- Aminolevulinic Acid (ALA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2021
- 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 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 19 and younger than 70 years
- Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum
- No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks
- At lease 20% of target great toe nail affected
Who cannot join
- Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance)
- Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis
- Patients with greater than 6 toenails affected
- Over 90% of target great toe affected
- Evidence of fingernail fungal infection
- Patients with recurrent serious infections or have been hospitalized in the preceding 6 months for infection
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- Patients with known history of HIV or hepatitis B or C infection
- Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease
- Any subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology at the Whitaker Clinic
Birmingham, Alabama, 35249
About this study
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Read the detailed description
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
- Being tested
- Aminolevulinic Acid (ALA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic Acid (ALA)Procedure or surgery
Also called ALA is a topical drug used in the administration of PDT.
Photosensitizing
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic Therapy (PDT) | Other | PDT with ALA (photosensitizer) for 3 hours Receives: Procedure: Aminolevulinic Acid (ALA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
Based on presence of fungal infection from culture assessment
Measured: 3 weeks after baseline
Number of subjects with clinical cure based on photographs after the 3rd treatment session
Based on visual assessment of photographs: presence or absence of fungal infection
Measured: 3 weeks after baseline
Secondary outcomes (5)
Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
Measured: 3 weeks after baseline
Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
Measured: 24 weeks after first treatment
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Measured: 1 week after baseline
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Measured: 2 weeks after baseline
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Measured: 3 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startSep 2015
- Primary completionSep 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toenail OnychomycosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Boni Elewski, University of Alabama at Birmingham
- Investigators
- Boni E Elewski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022903
- Sponsor's protocol ID
- F150128007
- Status last verified
- Feb 2022
- First submitted
- 16 Oct 2015
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT03022903
- Acronym / sponsor ID
- F150128007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Detailed description
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
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 (PDT) | Other | Procedure: Aminolevulinic Acid (ALA)PDT with ALA (photosensitizer) for 3 hours |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 19 and younger than 70 years
- Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum
- No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks
- At lease 20% of target great toe nail affected
Key exclusion criteria (9 listed)
- Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance)
- Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis
- Patients with greater than 6 toenails affected
- Over 90% of target great toe affected
- Evidence of fingernail fungal infection
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 |
|---|---|---|
| Aminolevulinic Acid (ALA)Also: ALA is a topical drug used in the administration of PDT.Photosensitizing | Procedure or surgery | Photodynamic Therapy (PDT) |
Primary outcome
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
Time frame: 3 weeks after baseline
Based on presence of fungal infection from culture assessment
Number of subjects with clinical cure based on photographs after the 3rd treatment session
Time frame: 3 weeks after baseline
Based on visual assessment of photographs: presence or absence of fungal infection
5 secondary outcomes
Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
Time frame: 3 weeks after baseline
Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
Time frame: 24 weeks after first treatment
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time frame: 1 week after baseline
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time frame: 2 weeks after baseline
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time frame: 3 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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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.
Boni E Elewski, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminolevulinic Acid (ALA) in people with Toenail Onychomycosis and Distal and Lateral Subungual Toenail Onychomycosis, run by University of Alabama at Birmingham at 1 site in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 7 Feb 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session (time frame: 3 weeks after baseline). 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?
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 7 Feb 2022.