Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03141840
Other study ID # AB001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2017
Est. completion date February 8, 2019

Study information

Verified date February 2019
Source Abbell AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date February 8, 2019
Est. primary completion date February 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
ABL01
Experimental medical device
Placebo
ABL01 lacking active component

Locations

Country Name City State
Sweden Fotcompaniet Stockholm Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Abbell AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary Questionnaire regarding subjects opinion of the treatment, nail improvement. Subjects score (1-5) the perceived improvement of their nail condition. 12 months
Secondary Questionnaire regarding subjects opinion of the treatment, ease of use. Subjects score (1-5) the perceived ease of using ABL01. 12 months
Secondary 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. 12 months
Secondary 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. 12 months
Secondary Number of study subjects with clinical cure Clinical cure is established with a negative test for dermatophytes as assessed by DNA-analysis. 12 months
See also
  Status Clinical Trial Phase
Completed NCT03110029 - Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish Phase 4
Active, not recruiting NCT05110638 - Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis Phase 1
Completed NCT05260450 - Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser N/A
Completed NCT03382717 - Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis N/A
Not yet recruiting NCT06417983 - Topical Application of Essential Oils to Treat Onchomycosis
Withdrawn NCT03094468 - Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis Phase 3
Recruiting NCT05674747 - Pilot Study of Swift Microwave Device for Onychomycosis Phase 1/Phase 2
Recruiting NCT06006455 - Effect of the Erchonia® LunulaLaserâ„¢ for the Treatment of Toenail Onychomycosis N/A
Not yet recruiting NCT03098342 - Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment N/A
Completed NCT03216200 - Early Feasibility Study to Evaluate the Efficacy of the RenewalNailâ„¢ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail) N/A
Recruiting NCT04042857 - Safety and Efficacy of Next Science Gel on Toenail Fungus N/A
Active, not recruiting NCT05135910 - To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis Phase 2
Active, not recruiting NCT05139888 - Light Therapy for Onychomycosis Study N/A
Completed NCT04961684 - Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis N/A
Recruiting NCT04084782 - An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
Withdrawn NCT03066336 - A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus N/A