Distal subungual onychomycosis (DSO)
Conditions
Interventions
Product Name: MOB015B
Product Code: MOB015B
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: TERBINAFINE HYDROCHLORIDE
CAS Number: 78628-80-5
Concentration unit: % (W/W) percent weight/wei
Sponsors
Moberg Derma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. 18 – 70 years 3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail. 4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes) 5. Signed written informed consent 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 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Proximal subungual onychomycosis. 2. DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm) 3. ”Spike” of onychomycosis extending to eponychium of the target nail 4. Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 5. Other conditions than DSO known to cause abnormal nail appearance 6. Topical antifungal treatment of the nails within 1 month before screening 7. Systemic use of antifungal treatment within 3 months before screening 8. History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy 9. Immunosuppression 10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening 11. Known allergy to any of the tested treatment products 12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1) 13. Pre-menopausal (last menstruation = 1 year prior to screening) sexually active women who : • are pregnant or nursing • are not surgically sterile • are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this trial are to evaluate efficacy and safety of topical MOB015B in adults with DSO at 60 weeks.;Secondary Objective: Not applicable;Primary end point(s): The proportion of patients with mycological cure of the target nail, defined as negative fungal culture and negative direct microscopy.;Timepoint(s) of evaluation of this end point: At 60 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of patients with mycological cure of the target nail defined as negative fungal culture and negative direct KOH microscopy. 2. Negative fungal culture of the target nail 3. Negative direct microscopy of the target nail. 4. Negative PCR. 5. The proportion of patients with complete cure ( negative fungal culture, negative direct KOH microscopy and physician’s GES=5). 6. The proportion of patients with negative fungal culture, negative direct KOH microscopy and physician’s GES=4 or 5. 7. Patient’s subjective score and physician’s GES. 8. Terbinafine concentration in nail/nail bed. 9. Terbinafine concentration in plasma. ;Timepoint(s) of evaluation of this end point: 1. At 12, 24 and 36 weeks. 2. At 12, 24, 36 and 60 weeks. 3. At 12, 24, 36 and 60 weeks. 4. At 12, 24, 36 and 48 weeks. 5. At 12, 24, 36 and 60 weeks. 6. At 12, 24 and 36 weeks. 7. At 4, 12, 24, 36, 48 and 60 weeks. 8. At 24 weeks. 9. At 4 weeks. | — |
Countries
Sweden
Contacts
Public ContactClinical Development
Moberg Derma AB
Outcome results
None listed