Distal Subungual OnychomycosisPhase 3NCT02859519
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)
A Phase 3 study testing MOB015B in people with Distal Subungual Onychomycosis, run by Moberg Pharma AB at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Distal Subungual Onychomycosis
- What is being tested?
- MOB015B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2016to 13 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Study site
Fridley, Minnesota
Study site
Multiple Locations, California
Study site
Multiple Locations, Florida
Study site
Multiple Locations, Idaho
Study site
Multiple Locations, New Jersey
Study site
Multiple Locations, Oregon
Study site
Multiple Locations, Texas
Study site
Multiple Locations, Virginia
Study site
Rolling Meadows, Illinois
About this study
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.
Read the 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.
- Conditions
- Distal Subungual Onychomycosis
- Being tested
- MOB015B, MOB015B Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOB015BDrug
MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution
MOB015B VehicleDrug
MOB015B Vehicle without the active ingredient Terbinafine
| Study group | Role | What they receive |
|---|---|---|
| MOB015B | Experimental | Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime. Receives: 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. Receives: Drug: MOB015B Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 52
Secondary outcomes (2)
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.
Measured: Week 52
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.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startOct 2016
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Subungual OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859519
- Sponsor's protocol ID
- MOB015B-IV
- Status last verified
- Dec 2020
- First submitted
- 4 Aug 2016
- Last updated
- 24 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02859519
- Acronym / sponsor ID
- MOB015B-IV
- Conditions
- Distal Subungual Onychomycosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOB015B | Experimental | Drug: MOB015BSubjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime. |
| MOB015B Vehicle | Placebo comparator | Drug: MOB015B VehicleSubjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOB015BMOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution | Drug | MOB015B |
| MOB015B VehicleMOB015B Vehicle without the active ingredient Terbinafine | Drug | MOB015B Vehicle |
Primary outcome
Subjects with complete cure of the target toe nail at Week 52
Time frame: 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.
2 secondary outcomes
Subjects with mycological cure of the target toe nail at Week 52
Time frame: Week 52
Subjects with treatment success of the target toe nail at Week 52
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MOB015B in people with Distal Subungual Onychomycosis, run by Moberg Pharma AB at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects with complete cure of the target toe nail at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020; AzTrials last refreshed its copy on 28 Oct 2026.