A Multi-centre, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Completed · Phase 3

Conditions studied: Distal Subungual Onychomycosis

In brief

The primary objective of this study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate distal subungual onychomycosis (DSO). The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.

Key facts

Study ID

NCT02859519

Run by

Moberg Pharma AB

People needed

365

Starts

2016-10-01

Expected to finish

2019-11-13

Last updated by the study team

2020-12-24

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females 12 - 75 years of age
• Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail
• Positive culture for dermatophytes
• Written informed consent

You may not qualify if…

• Proximal subungual onychomycosis
• Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)
• Target toenail thickness more than 3 mm
• "Spike" of onychomycosis extending to eponychium of the target toenail
• Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
• Other conditions than DSO known to cause abnormal nail appearance
• Presence of toenail infection other than dermatophytes
• Previous target toenail surgery with any residual disfigurement
• Topical treatment of the nails with other antifungal medication within 6 weeks before screening/Visit 1
• Systemic use of antifungal treatment within 6 months before screening/visit 1
• Severe moccasin tinea pedis
• Signs of severe peripheral circulatory insufficiency
• Uncontrolled diabetes mellitus
• Known immunodeficiency
• Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2
• Known allergy to any of the tested treatment products
• A positive pregnancy test at Baseline/Visit 2 indicating pregnancy in a woman of childbearing potential or a premenarche subject
• Females who are pregnant or breastfeeding
• Men who have female sexual partners of child-bearing potential and sexually active women of child-bearing potential who are not practicing an acceptable method of birth control, or who will not remain abstinent through the trial.
• Patients previously randomized in this study
• History of, or current drug or alcohol abuse
• Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient's ability to completely understand the consequences of consent is missing
• Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor's company
• Patients who are institutionalized because of legal or regulatory order
• Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Where it is running

• Study site — Multiple Locations, California, United States
• Study site — Multiple Locations, Florida, United States
• Study site — Multiple Locations, Idaho, United States
• Study site — Rolling Meadows, Illinois, United States
• Study site — Fridley, Minnesota, United States
• Study site — Multiple Locations, New Jersey, United States
• Study site — Multiple Locations, Oregon, United States
• Study site — Multiple Locations, Texas, United States
• Study site — Multiple Locations, Virginia, United States
• Study site — Multiple Locations, Canada

Full record on ClinicalTrials.gov

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