Distal Subungual Onychomycosis MedDRA version: 20.0 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: MOB015B
Product Code: MOB015B
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Terbinafine-Hydrochloride
CAS Number: 78628-80-5
Current Sponsor code: MOB015B
Concentration un
Sponsors
Moberg Pharma AB (publ)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females 18 – 75 years of age (inclusive) at the time of Informed Consent 2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail 3. Positive culture for dermatophytes 4. Signed written informed consent (ICF) prior to any study-related activity Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 406 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: 1. Proximal subungual onychomycosis 2. 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) 3. Target toenail thickness more than 3 mm 4. ”Spike” of onychomycosis extending to eponychium of the target toenail 5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 6. Other conditions than DSO known to cause abnormal nail appearance 7. Presence of toenail infection other than dermatophytes 8. Previous target toenail surgery with any residual disfigurement 9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before Screening/Visit 1 10. Systemic use of antifungal treatment within 6 months before Screening / Visit 1 11. Severe moccasin tinea pedis 12. Signs of severe peripheral circulatory insufficiency 13. Uncontrolled diabetes mellitus (blood glucose not adjusted to stable levels despite antidiabetic therapy and / or careful medical monitoring by the family physician / specialist is not ensured) 14. Known immunodeficiency, i.e. congenital immunodeficiency, acquired immunodeficiency (e.g. HIV, some bone marrow diseases, extreme diets), iatrogenic by immunosuppressive drugs like cytostatics or by radiation therapy or immunomodulatory medications (e.g. TNF inhibitors) 15. Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2 16. Known allergy to any of the tested treatment products 17. A positive pregnancy test indicating pregnancy in a woman of childbearing potential* at Baseline/ Visit 2 18. Females who are pregnant or breastfeeding 19. Pre-menopausal (last menstruation = 1 year prior to screening) sexually active women who: • are of childbearing potential* and are not practicing an acceptable method of birth control**, or do not plan to continue practicing an acceptable method of birth control throughout the trial 20. Patients previously randomized in this study 21. History of, or current drug or alcohol abuse 22. 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 23. 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 24. Patients who are institutionalized because of legal or regulatory order 25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this phase III study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate DSO.;Secondary Objective: The secondary objective of this phase III study is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.;Primary end point(s): • Patients with complete cure at Week 52 Complete cure is defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical involvement of the target nail. ;Timepoint(s) of evaluation of this end point: Week 52 of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Complete cure (negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement) of target nail at other time points than the primary endpoint (i.e., Visit 3, 4, 5, and 6) • Mycological cure of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Negative fungal culture of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Negative direct KOH microscopy of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • “Completely clear” or “almost clear” target nail (i.e., 0-10% clinical disease involvement of the target nail) during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Treatment success (defined as “completely clear” or “almost clear” and negative mycology) of target nail during the treatment period (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Patient´s subjective score of all treated nails except the little toenail(s) during the treatment period of the study (Visit 3, 4, 5, and 6) and at the end of follow-up (Visit 7) • Patient´s assessment of IMP handling (Visit 3) ;Timepoint(s) of evaluation of this end point: • Complete Cure at other visits than Week 52 (i.e. Visits 3, 4, 5 and 6 • Mycological cure of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Negative fungal culture of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Negative direct KOH microscopy of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) •“Completely clear” or “almost clear” target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Treatment success (defined as “completely clear” or “almost clear” and negative mycology) of target nail at Visits 3, 4, 5, 6 and end of Follow-Up (Visit 7) • Patient´s subjective score of all treated nails except the little toenail(s) | — |
Countries
Germany, Poland, United Kingdom
Contacts
Public ContactProject Leader
Moberg Pharma AB (publ)
Outcome results
None listed