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

Moberg Pharma AB35 sites in 2 countries350 target enrollmentMay 9, 2022

ConditionsOnychomycosis

InterventionsMOB015B Vehicle (Placebo Comparator)

DrugsMOB015B Vehicle (Placebo Comparator)

Overview

Phase: Phase 3
Intervention: MOB015B
Conditions: Onychomycosis
Sponsor: Moberg Pharma AB
Enrollment: 350
Locations: 35
Primary Endpoint: Incidence of adverse events (Safety)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 3 multicenter, double-blind study to evaluate the safety and efficacy of vehicle-controlled topical MOB015B in the treatment of Distal Subungual Onychomycosis (DSO)

Detailed Description

Distal subungual onychomycosis (DSO) is the most common form of Onychomycosis, in which fungi invade the underside of the nail plate. The infection may worsen, spread to other uninfected areas or infect other people. Without treatment the disease may have an impact on an individual's quality of life. MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. All ingredients in MOB015B have a well-established use in approved pharmaceuticals for dermatological use. The purpose of this study is to evaluate the efficacy and safety of a new reduced dose treatment regimen of MOB015B whereby the investigational medicinal product (IMP) is applied daily for 8 weeks and then reduced to once weekly treatment for 40 weeks.

Registry

clinicaltrials.gov

Start Date

May 9, 2022

End Date

January 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Moberg Pharma AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females 12 to 75 years of age
•Distal subungual onychomycosis of at least one of the great toenail(s) affecting 20% to 60% of the target great toenail (verified by a central blinded assessor before randomization)
•Positive KOH microscopy and culture for dermatophytes in the target toenail
•Ability of the great toenail to grow (e.g., subject reports cutting toenails at least monthly)
•Signed written informed consent and assent (if applicable)

Exclusion Criteria

•Proximal subungual onychomycosis, superficial white onychomycosis, or significant dystrophy judged clinically by the blinded assessor or by the Investigator that may interfere with clinical evaluation of onychomycosis
•Distal subungual onychomycosis where disease involvement has extended into the proximal portion of the target toenail and the unaffected proximal nail is less than 3 mm measured from proximal nail fold
•Target toenail thickness more than 3 mm measured at the distal end
•"Spike" of onychomycosis extending to eponychium of the target toenail
•Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin) or severe onychorrhexis on the target toenail
•Nail conditions other than DSO that are known to cause abnormal nail appearance, presence of melanonychia or subungual hematoma that could obscure visualization of nail clearing
•Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte
•Previous target toenail surgery (within 6 months) with any residual disfigurement that will impact efficacy outcome or will not allow nail to grow normally, as judged by the Investigator
•Topical treatment of the toenails with other antifungal medication within 6 weeks before Screening/Visit 1
•History of failing oral therapy for onychomycosis within the past 3 years, or inability for nail to appear normal due to trauma, as judged by the Investigator