OnychomycosisNCT01915355
Pulsed Dye Laser Treatment of Onychomycosis
A study testing Pulsed Dye Laser for the treatment of nail fungus in people with Onychomycosis, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus. Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Pulsed Dye Laser for the treatment of nail fungus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 years old
- Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping
Who cannot join
- HIV/immunosuppression
- Candidal toenail infection
- Prior PO antifungal therapy within last 6 months
- Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
- Any serious generalized medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Dermatology Associates
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.
Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.
Read the detailed description
10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.
- Conditions
- Onychomycosis
- Being tested
- Pulsed Dye Laser for the treatment of nail fungus
- Keywords
- onychomycosis, nail, fungus
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Dye Laser for the treatment of nail fungusDevice
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Dye Laser for fungus treatment | Experimental | The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus. Receives: Device: Pulsed Dye Laser for the treatment of nail fungus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nail Clearance
After 3 laser treatments, the subject should experience clinical clearance.
Measured: approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazanin Saedi, MD, Principal investigator, Jefferson Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915355
- Sponsor's protocol ID
- IRB 13D.230
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Dye Laser Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT01915355
- Acronym / sponsor ID
- IRB 13D.230
- Conditions
- Onychomycosis
- Keywords
- onychomycosis, nail, fungus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Aug 2013 (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.
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.
Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.
Detailed description
10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Dye Laser for fungus treatment | Experimental | Device: Pulsed Dye Laser for the treatment of nail fungusThe purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-65 years old
- Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping
Key exclusion criteria (5 listed)
- HIV/immunosuppression
- Candidal toenail infection
- Prior PO antifungal therapy within last 6 months
- Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
- Any serious generalized medical condition
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 |
|---|---|---|
| Pulsed Dye Laser for the treatment of nail fungusThe purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus. | Device | Pulsed Dye Laser for fungus treatment |
Primary outcome
Total Nail Clearance
Time frame: approximately 12 weeks
After 3 laser treatments, the subject should experience clinical clearance.
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 19 Aug 2016.
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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.
Nazanin Saedi, MD principal investigator
Jefferson Dermatology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Dye Laser for the treatment of nail fungus in people with Onychomycosis, run by Thomas Jefferson University 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 2 inclusion and 5 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 19 Aug 2016. 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?
Total Nail Clearance (time frame: approximately 12 weeks). 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 19 Aug 2016.