Back to resultsA 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)
Primary Purpose
Distal Subungual Onychomycosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MOB015B
MOB015B Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Distal Subungual Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MOB015B
MOB015B Vehicle
Arm Description
Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime.
Subjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Subjects with mycological cure of the target toe nail at Week 52
Mycological cure was defined as negative fungal culture of dermatophytes and negative direct KOH microscopy of the target toenail.
Subjects with treatment success of the target toe nail at Week 52
Treatment success was defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and ≤10% clinical disease involvement of the target toenail.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02859519
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moberg Pharma AB
4. Oversight
5. Study Description
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.
Detailed Description
Male or female subjects aged between 12 and 75 years with confirmed DSO involving 20-60% of at least one great toenail will be screened for randomization in this study. The diagnosis of DSO will be confirmed prior to randomization through a positive culture of dermatophytes. In addition, a central blinded assessment of the clinical disease involvement (i.e., affected nail area) will be performed at Screening. Subjects have to meet all eligibility criteria before being randomized in to the study.
Eligible subjects will be randomized to the investigational medicinal products (MOB015B or vehicle) in a ratio of 2:1. The investigational medicinal products (IMPs) will be applied to all affected fingernails and/or toenails for 48 weeks once daily at bedtime. However, fingernails will not be assessed for efficacy.
Since both the IMPs are indistinguishable in appearance and mode of administration, the study will be performed as a double-blind study, i.e., both the investigator and the subject will remain blinded throughout the entire study.
After a 4-week follow-up period without IMP treatment the end of study (EoS) Visit will be performed at Week 52 (Visit 7). The primary efficacy variable will be assessed at Week 52. The end of the clinical study for each individual subject is defined as the EoS Visit at Week 52 (Visit 7). The end of the clinical study is defined as the last visit of the last subject in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Subungual Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
365 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOB015B
Arm Type
Experimental
Arm Description
Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime.
Arm Title
MOB015B Vehicle
Arm Type
Placebo Comparator
Arm Description
Subjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime.
Intervention Type
Drug
Intervention Name(s)
MOB015B
Intervention Description
MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution
Intervention Type
Drug
Intervention Name(s)
MOB015B Vehicle
Intervention Description
MOB015B Vehicle without the active ingredient Terbinafine
Primary Outcome Measure Information:
Title
Subjects with complete cure of the target toe nail at Week 52
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Subjects with mycological cure of the target toe nail at Week 52
Description
Mycological cure was defined as negative fungal culture of dermatophytes and negative direct KOH microscopy of the target toenail.
Time Frame
Week 52
Title
Subjects with treatment success of the target toe nail at Week 52
Description
Treatment success was defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and ≤10% clinical disease involvement of the target toenail.
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
City
Multiple Locations
State/Province
California
Country
United States
City
Multiple Locations
State/Province
Florida
Country
United States
City
Multiple Locations
State/Province
Idaho
Country
United States
City
Rolling Meadows
State/Province
Illinois
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
Multiple Locations
State/Province
New Jersey
Country
United States
City
Multiple Locations
State/Province
Oregon
Country
United States
City
Multiple Locations
State/Province
Texas
Country
United States
City
Multiple Locations
State/Province
Virginia
Country
United States
City
Multiple Locations
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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)
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