Clinical Trial: Clinical Trial of Topical ABL01 Treatment of Onychomycosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis

Brief 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.

Detailed Summary:

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.


Sponsor: Abbell AB

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Abbell AB

Dates:
Date Received: May 2, 2017
Date Started: May 2017
Date Completion: December 2018
Last Updated: May 8, 2017
Last Verified: May 2017