A Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
- Conditions
- Onychomycosis
- Interventions
- Drug: MOB015BDrug: Vehicle (Placebo Comparator)
- Registration Number
- NCT05279846
- Lead Sponsor
- Moberg Pharma AB
- Brief 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)
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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)
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MOB015B MOB015B Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks Control Arm Vehicle (Placebo Comparator) Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks
- Primary Outcome Measures
Name Time Method Incidence of adverse events (Safety) 52 Week Safety as determined by the incidence of adverse events (AEs)
Proportion of subjects with complete cure of the target toenail 52 Week Defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide \[KOH\] microscopy and 0% clinical disease involvement
- Secondary Outcome Measures
Name Time Method Proportion of subjects with mycological cure of target toenail 52 Week Defined as negative fungal culture of dermatophytes and negative direct KOH microscopy)
Proportion of subjects with treatment success of target toenail 52 Week Defined as nails that are "completely clear" or "almost clear" of clinical diseases and negative mycology
Trial Locations
- Locations (35)
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
IMA Clinical Research
🇺🇸Monroe, Louisiana, United States
Weill Cornell Medicine Dermatology
🇺🇸New York, New York, United States
Center for Dermatology Clinical Research,Inc
🇺🇸Fremont, California, United States
Driven Research LLC
🇺🇸Coral Gables, Florida, United States
Michigan Center for Skin Care Research
🇺🇸Clinton Township, Michigan, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
The South Bend Clinic, LLC
🇺🇸South Bend, Indiana, United States
Associated Skin Care Specs
🇺🇸New Brighton, Minnesota, United States
Center for Clinical Research
🇺🇸San Francisco, California, United States
UPMC Department of Dermatology
🇺🇸Pittsburgh, Pennsylvania, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
University of Alabama Hospital
🇺🇸Birmingham, Alabama, United States
Colorado Medical Research Center
🇺🇸Denver, Colorado, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Mediprobe Research
🇨🇦London, Ontario, Canada
Doctors Research Institute Corporation
🇺🇸South Miami, Florida, United States
Olympian Clinical Research
🇺🇸Clearwater, Florida, United States
Forest Hills Dermatology Group
🇺🇸Kew Gardens, New York, United States
Haber Dermatology, Inc.
🇺🇸Beachwood, Ohio, United States
Futuro Clinical Trials LLC
🇺🇸McAllen, Texas, United States
David Fivenson, MD, Dermatology, PLLC
🇺🇸Ann Arbor, Michigan, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Skin Search of Rochester
🇺🇸Rochester, New York, United States
Podiatry 1st
🇺🇸O'Fallon, Illinois, United States
DelRicht Research - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
UNC Dermatology and Skin Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Martin Foot and Ankle
🇺🇸York, Pennsylvania, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
Houston Center for Clinical Research
🇺🇸Sugar Land, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States