Clinical Trial of Topical ABL01 Treatment of Onychomycosis
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|ClinicalTrials.gov Identifier: NCT03141840|
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis of Toenail||Device: ABL01 Device: Placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind randomized controlled trail comparing ABL01 and placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Study subjects are randomly assigned to treatment or placebo groups by a predetermined algoritm using sealed envelopes.|
|Official Title:||Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis|
|Actual Study Start Date :||August 14, 2017|
|Actual Primary Completion Date :||February 8, 2019|
|Actual Study Completion Date :||February 8, 2019|
Experimental group: ABL01 is to be applied topically to the infected nail once a week during the study period to counter onychomycosis.
Experimental medical device
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.
ABL01 lacking active component
- 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.
- Questionnaire regarding subjects opinion of the treatment, nail improvement. [ Time Frame: 12 months ]Subjects score (1-5) the perceived improvement of their nail condition.
- Questionnaire regarding subjects opinion of the treatment, ease of use. [ Time Frame: 12 months ]Subjects score (1-5) the perceived ease of using ABL01.
- Number of study subjects with treatment-related adverse events [ Time Frame: 12 months ]Subject reported safety data in combination with reported adverse events and adverse device effects related to the topical administration of ABL01.
- Number of study subjects with a reduction in infected area of the nail [ Time Frame: 12 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 80% reduction in infected area at the 12 month time period.
- Number of study subjects with clinical cure [ Time Frame: 12 months ]Clinical cure is established with a negative test for dermatophytes as assessed by DNA-analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141840
|Stockholm, Sweden, 113 52|
|Principal Investigator:||Irini Mouratidou-Kontorinis||Fotcompaniet Stockholm|