Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

NCT02866032 | Completed Phase 3

• 1 other identifier: MOB015B-III
• Study Type: interventional
• Target: 452
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Distal Subungual Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Complete cure of the target nail defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement at Week 52

  Week 52

Study Arms (2)

MOB015B

EXPERIMENTAL

Drug: MOB015B

Ciclopirox 80 mg/g

ACTIVE COMPARATOR

Drug: Ciclopirox 80 mg/g

Interventions

MOB015B DRUG

MOB015B

Ciclopirox 80 mg/g DRUG

Ciclopirox 80 mg/g

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18 - 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
• Signed 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 or medical device 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

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (3)

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Poland

Location

Unknown Facility

Multiple Locations, United Kingdom

Location

MeSH Terms

Interventions

Ciclopirox

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 15, 2016
• Study Start: September 1, 2016
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

DE (1); PL (1); GB (1)