NCT02859519

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2016

Typical duration for phase_3

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

3.1 years

First QC Date

August 4, 2016

Last Update Submit

December 16, 2020

Conditions

Distal Subungual Onychomycosis

Outcome Measures

Primary Outcomes (1)

  • Subjects with complete cure of the target toe nail at Week 52

    Complete cure was defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide (KOH) microscopy and 0% clinical disease involvement of the target toenail.

    Week 52

Secondary Outcomes (2)

  • Subjects with mycological cure of the target toe nail at Week 52

    Week 52

  • Subjects with treatment success of the target toe nail at Week 52

    Week 52

Study Arms (2)

MOB015B

EXPERIMENTAL

Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime.

Drug: MOB015B

MOB015B Vehicle

PLACEBO COMPARATOR

Subjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime.

Drug: MOB015B Vehicle

Interventions

MOB015BDRUG

MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution

MOB015B
MOB015B VehicleDRUG

MOB015B Vehicle without the active ingredient Terbinafine

MOB015B Vehicle

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Multiple Locations, California, United States

Location

Unknown Facility

Multiple Locations, Florida, United States

Location

Unknown Facility

Multiple Locations, Idaho, United States

Location

Unknown Facility

Rolling Meadows, Illinois, United States

Location

Unknown Facility

Fridley, Minnesota, United States

Location

Unknown Facility

Multiple Locations, New Jersey, United States

Location

Unknown Facility

Multiple Locations, Oregon, United States

Location

Unknown Facility

Multiple Locations, Texas, United States

Location

Unknown Facility

Multiple Locations, Virginia, United States

Location

Unknown Facility

Multiple Locations, Canada

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

October 1, 2016

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

US(9)CA(1)