OnychomycosisPhase 3NCT05279846
A Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
A Phase 3 study testing MOB015B in people with Onychomycosis, run by Moberg Pharma AB at 35 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- MOB015B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 9 May 2022to Jan 2025
- 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 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)
Who cannot join
- 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
Show all 25Show fewer
- 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
- Systemic use of antifungal treatment within 6 months before Screening/Visit 1
- Moderate to severe moccasin tinea pedis that require prolonged topical antifungal treatment or oral antifungal treatment should be excluded. Subjects with symptomatic interdigital tinea pedis or mild moccasin type tinea pedis will be screen failed. However, However, they will be allowed to enter the study after appropriate effective treatment and washout period as per Investigator judgment.
- Signs of severe peripheral circulatory insufficiency as determined by significantly diminished/lack of pedal pulse on either foot
- Subjects with a current or past history of psoriasis and/or lichen planus
- Subjects with poorly controlled (or uncontrolled) diabetes mellitus as determined by HbA1c of > 8%
- Known immunodeficiency, i.e., congenital immunodeficiency, acquired immunodeficiency, iatrogenic by immunosuppressive drugs like cytostatics or by radiation therapy or immunomodulatory medications (e.g., TNF inhibitors)
- Participation in another clinical trial with an investigational drug or device during the previous 3 months before enrollment/baseline and for the duration of this study
- Known allergy to any of the tested treatment products
- Female subjects who are pregnant or breastfeeding; or intend to conceive a child during the duration of the study (52 weeks).
- Subjects previously randomized to any study involving MOB015B treatment/exposure
- History of, or current drug or alcohol abuse that would interfere with a subject's ability to participate in the study as determined by the Investigator
- Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the subject'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 the same study site, or subject who is an employee of the Sponsor/designee
- Subjects who are institutionalized because of legal or regulatory order
- Any diseases or circumstances in which the subject should not participate in the study in the opinion of the Investigator
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States33 sites
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, 48103
DermResearch, Inc.
Austin, Texas, 78759
DelRicht Research - Baton Rouge
Baton Rouge, Louisiana, 70809
Haber Dermatology, Inc.
Beachwood, Ohio, 44122
Hassman Research Institute
Berlin, New Jersey, 08009
University of Alabama Hospital
Birmingham, Alabama, 35233
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
Olympian Clinical Research
Clearwater, Florida, 33756
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Driven Research LLC
Coral Gables, Florida, 33134
Colorado Medical Research Center
Denver, Colorado, 80210
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Center for Dermatology Clinical Research,Inc
Fremont, California, 94538
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Dermatology Research Associates
Los Angeles, California, 90045
Futuro Clinical Trials LLC
McAllen, Texas, 78501
IMA Clinical Research
Monroe, Louisiana, 71201
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Associated Skin Care Specs
New Brighton, Minnesota, 55112
Weill Cornell Medicine Dermatology
New York, New York, 10021
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Podiatry 1st
O'Fallon, Illinois, 62269
Skin Specialists, PC
Omaha, Nebraska, 68144
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Skin Search of Rochester
Rochester, New York, 14623
Progressive Clinical Research, PA
San Antonio, Texas, 78213
Center for Clinical Research
San Francisco, California, 94115
The South Bend Clinic, LLC
South Bend, Indiana, 46617
Doctors Research Institute Corporation
South Miami, Florida, 33143
Houston Center for Clinical Research
Sugar Land, Texas, 77479
Martin Foot and Ankle
York, Pennsylvania, 17402
Canada2 sites
Mediprobe Research
London, Ontario, N5X 2P1
Toronto Research Centre
Toronto, Ontario
About this study
Official title: 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)
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)
Read the 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.
- Conditions
- Onychomycosis
- Being tested
- MOB015B, Vehicle (Placebo Comparator)
- Keywords
- Nail Fungus, Antifungal, Terbinafine, Distal Subungual Onychomycosis (DSO)
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOB015BDrug
Applied topically for 48 weeks
Vehicle (Placebo Comparator)Drug
Applied topically for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| MOB015B | Experimental | Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks Receives: Drug: MOB015B |
| Control Arm | Placebo comparator | Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks Receives: Drug: Vehicle (Placebo Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with complete cure of the target toenail
Defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide [KOH] microscopy and 0% clinical disease involvement
Measured: 52 Week
Incidence of adverse events (Safety)
Safety as determined by the incidence of adverse events (AEs)
Measured: 52 Week
Secondary outcomes (2)
Proportion of subjects with mycological cure of target toenail
Defined as negative fungal culture of dermatophytes and negative direct KOH microscopy)
Measured: 52 Week
Proportion of subjects with treatment success of target toenail
Defined as nails that are "completely clear" or "almost clear" of clinical diseases and negative mycology
Measured: 52 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start9 May 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279846
- Sponsor's protocol ID
- MOB015B-33-21-001
- Status last verified
- Jun 2024
- First submitted
- 4 Mar 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05279846
- Acronym / sponsor ID
- MOB015B-33-21-001
- Conditions
- Onychomycosis
- Keywords
- Nail Fungus, Antifungal, Terbinafine, Distal Subungual Onychomycosis (DSO)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Mar 2022 (actual)
- 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.
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.
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: MOB015BApplied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks |
| Control Arm | Placebo comparator | Drug: Vehicle (Placebo Comparator)Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
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 |
|---|---|---|
| MOB015BApplied topically for 48 weeks | Drug | MOB015B |
| Vehicle (Placebo Comparator)Applied topically for 48 weeks | Drug | Control Arm |
Primary outcome
Proportion of subjects with complete cure of the target toenail
Time frame: 52 Week
Defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide [KOH] microscopy and 0% clinical disease involvement
Incidence of adverse events (Safety)
Time frame: 52 Week
Safety as determined by the incidence of adverse events (AEs)
2 secondary outcomes
Proportion of subjects with mycological cure of target toenail
Time frame: 52 Week
Proportion of subjects with treatment success of target toenail
Time frame: 52 Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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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.
35 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 Onychomycosis, run by Moberg Pharma AB at 35 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 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
Results are not available in the source record.
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?
Proportion of subjects with complete cure of the target toenail (time frame: 52 Week). The study lists 2 primary outcomes in all. 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 26 Jun 2024.