Onychomycosis of ToenailNCT03141840
Clinical Trial of Topical ABL01 Treatment of Onychomycosis
A study testing ABL01 in people with Onychomycosis of Toenail, run by Abbell AB at 1 site in Sweden.
Trial summary
This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- ABL01
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- 14 Aug 2017to 8 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Men and women above age 18 weighing over 40 kg
- Present with distal lateral subungual onychomycosis of any of the big toe nails
- The onychomycosis should involve less than 50 % of the nail bed and may not have reached the cuticle
Who cannot join
- Unable to come for study visits
- Known allergy to any of the components in ABL01
- Not willing to participate in the trial or not able to understand the content of the trial
- Present with proximal subungual onychomycosis or superficial onychomycosis.
- Present with distal lateral subungual onychomycosis of other nails than the big toe.
- More than 50 % of the nailbed affected by onychomycosis or the cuticles infected
Show all 13Show fewer
- Known conditions (like psoriasis) that cause abnormal nail appearance
- Nail damage caused by trauma, pressure or other mechanical reasons
- Currently on immunosuppressive therapy
- Showing signs of poor peripheral blood circulation
- Used another topical antifungal treatment within 1 month of screening
- Used a systemic antifungal treatment within 3 months of screening
- Participated in any other clinical onychomycosis trial in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis
This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.
Read the detailed description
The purpose of this clinical trial is to determine the safety and effectiveness of the medical device ABL01. The intended use of ABL01 is to reduce and treat onychomycosis, fungal nail infection. ABL01 is a solution intended to be topically administered weekly to infected nails. The trial is designed as a double blinded randomized placebo controlled clinical trial. The trial involves 70 study subjects, half of which will receive ABL01 and the other half placebo. The inclusion criteria for study subjects are adult men and women that present with distal lateral subungual onychomycosis (DSU) on the big toe nails. Furthermore, the extent of DSU should not involve more than half of the area of the nail.
The study subjects will themselves apply the study solution weekly to the treated nail. The trial will run for 6 months with a possible extension to maximum 12 months. There will be a total of 4 study visits at baseline, 3, 6 and 12 months to follow up the progress of the trial. The primary objective of the trial is to determine if ABL01 treatment are able to reduce and treat onychomycosis. Secondary objectives are to collect safety data, determine if the ABL01 are perceived as easy to use and assess long term effects of the treatment. The endpoint of the trial is reduction in clinical signs or complete cure of onychomycosis at the 6- or 12-month time-point.
- Conditions
- Onychomycosis of Toenail
- Being tested
- ABL01, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL01Device
Experimental medical device
PlaceboDevice
ABL01 lacking active component
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental group: ABL01 is to be applied topically to the infected nail once a week during the study period to counter onychomycosis. Receives: Device: ABL01 |
| Control | Placebo comparator | Control group: Placebo solution to be applied topically to the infected nail once a week during the study period to counter onychomycosis. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study subjects with a reduction in infected nail area at 6 months.
Clinical improvement of the condition is assessed by analyzing changes in infected nail area (in relation to total nail area) due to ABL01 or placebo treatment. Clinical improvement is considered to be a 40% reduction in infected area at the 6 month time period.
Measured: 6 months
Secondary outcomes (5)
Questionnaire regarding subjects opinion of the treatment, nail improvement.
Subjects score (1-5) the perceived improvement of their nail condition.
Measured: 12 months
Questionnaire regarding subjects opinion of the treatment, ease of use.
Subjects score (1-5) the perceived ease of using ABL01.
Measured: 12 months
Number of study subjects with treatment-related adverse events
Subject reported safety data in combination with reported adverse events and adverse device effects related to the topical administration of ABL01.
Measured: 12 months
Number of study subjects with a reduction in infected area of the nail
Clinical improvement of the condition is assessed by analyzing changes in infected nail area (in relation to total nail area) due to ABL01 or placebo treatment. Clinical improvement is considered to be a 80% reduction in infected area at the 12 month time period.
Measured: 12 months
Number of study subjects with clinical cure
Clinical cure is established with a negative test for dermatophytes as assessed by DNA-analysis.
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 posted5 May 2017
- Study start14 Aug 2017
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized controlled trail comparing ABL01 and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbell AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irini Mouratidou-Kontorinis, Principal investigator, Fotcompaniet Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141840
- Sponsor's protocol ID
- AB001
- Status last verified
- Feb 2019
- First submitted
- 2 May 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT03141840
- Acronym / sponsor ID
- AB001
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Abbell ABIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 5 May 2017 (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.
This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.
Detailed description
The purpose of this clinical trial is to determine the safety and effectiveness of the medical device ABL01. The intended use of ABL01 is to reduce and treat onychomycosis, fungal nail infection. ABL01 is a solution intended to be topically administered weekly to infected nails. The trial is designed as a double blinded randomized placebo controlled clinical trial. The trial involves 70 study subjects, half of which will receive ABL01 and the other half placebo. The inclusion criteria for study subjects are adult men and women that present with distal lateral subungual onychomycosis (DSU) on the big toe nails. Furthermore, the extent of DSU should not involve more than half of the area of the nail.
The study subjects will themselves apply the study solution weekly to the treated nail. The trial will run for 6 months with a possible extension to maximum 12 months. There will be a total of 4 study visits at baseline, 3, 6 and 12 months to follow up the progress of the trial. The primary objective of the trial is to determine if ABL01 treatment are able to reduce and treat onychomycosis. Secondary objectives are to collect safety data, determine if the ABL01 are perceived as easy to use and assess long term effects of the treatment. The endpoint of the trial is reduction in clinical signs or complete cure of onychomycosis at the 6- or 12-month time-point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trail comparing ABL01 and placebo.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ABL01Experimental group: ABL01 is to be applied topically to the infected nail once a week during the study period to counter onychomycosis. |
| Control | Placebo comparator | Device: PlaceboControl group: Placebo solution to be applied topically to the infected nail once a week during the study period to counter onychomycosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written informed consent
- Men and women above age 18 weighing over 40 kg
- Present with distal lateral subungual onychomycosis of any of the big toe nails
- The onychomycosis should involve less than 50 % of the nail bed and may not have reached the cuticle
Key exclusion criteria (13 listed)
- Unable to come for study visits
- Known allergy to any of the components in ABL01
- Not willing to participate in the trial or not able to understand the content of the trial
- Present with proximal subungual onychomycosis or superficial onychomycosis.
- Present with distal lateral subungual onychomycosis of other nails than the big toe.
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 |
|---|---|---|
| ABL01Experimental medical device | Device | Experimental |
| PlaceboABL01 lacking active component | Device | Control |
Primary outcome
Number of study subjects with a reduction in infected nail area at 6 months.
Time frame: 6 months
Clinical improvement of the condition is assessed by analyzing changes in infected nail area (in relation to total nail area) due to ABL01 or placebo treatment. Clinical improvement is considered to be a 40% reduction in infected area at the 6 month time period.
5 secondary outcomes
Questionnaire regarding subjects opinion of the treatment, nail improvement.
Time frame: 12 months
Questionnaire regarding subjects opinion of the treatment, ease of use.
Time frame: 12 months
Number of study subjects with treatment-related adverse events
Time frame: 12 months
Number of study subjects with a reduction in infected area of the nail
Time frame: 12 months
Number of study subjects with clinical cure
Time frame: 12 months
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 20 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Irini Mouratidou-Kontorinis principal investigator
Fotcompaniet Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABL01 in people with Onychomycosis of Toenail, run by Abbell AB at 1 site in Sweden.
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 4 inclusion and 13 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 20 Feb 2019. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 study subjects with a reduction in infected nail area at 6 months. (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 20 Feb 2019.