- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141840
Clinical Trial of Topical ABL01 Treatment of Onychomycosis
Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden, 113 52
- Fotcompaniet Stockholm
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Experimental group: ABL01 is to be applied topically to the infected nail once a week during the study period to counter onychomycosis.
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Experimental medical device
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Placebo Comparator: Control
Control group: Placebo solution to be applied topically to the infected nail once a week during the study period to counter onychomycosis.
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ABL01 lacking active component
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of study subjects with a reduction in infected nail area at 6 months.
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire regarding subjects opinion of the treatment, nail improvement.
Time Frame: 12 months
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Subjects score (1-5) the perceived improvement of their nail condition.
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12 months
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Questionnaire regarding subjects opinion of the treatment, ease of use.
Time Frame: 12 months
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Subjects score (1-5) the perceived ease of using ABL01.
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12 months
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Number of study subjects with treatment-related adverse events
Time Frame: 12 months
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Subject reported safety data in combination with reported adverse events and adverse device effects related to the topical administration of ABL01.
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12 months
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Number of study subjects with a reduction in infected area of the nail
Time Frame: 12 months
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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.
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12 months
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Number of study subjects with clinical cure
Time Frame: 12 months
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Clinical cure is established with a negative test for dermatophytes as assessed by DNA-analysis.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irini Mouratidou-Kontorinis, Fotcompaniet Stockholm
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AB001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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