Distal subungual onychomycosis (DSO) MedDRA version: 12.1 Level: LLT Classification code 10030338 Term: Onychomycosis
Conditions
Interventions
Product Name: MOB015
Product Code: MOB015
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: Terbinafine hydrochloride
CAS Number: 78628-80-5
Concentration unit: % percent
Concentration ty
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 (verified by blinded assessor before randomization) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Signs of severe peripheral circulatory insufficiency 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 practicing 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 |
|---|---|
| Secondary Objective: Secondary efficacy variables: Mycological cure of target nail at 1, 3, 6 and 9 months, Negative fungal culture of target nail at 1, 3, 6, 9 and 12 months nail at 1, 3, 6, 9, Negative direct KOH microscopy at 1, 3, 6, 9 and 12 months, Negative fungal culture, negative direct KOH microscopy and physician’s GES = 4 or 5 at 1, 3, 6, 9 and 12 months, Complete cure (negative fungal culture, negative direct KOH microscopy and physician’s GES = 5) at 1, 3, 6, 9 and 12 months, Change from baseline in length of unaffected target nail at 3, 6, 9 and 12 months, Physician´s GES of target nail at 1, 3, 6, 9 and 12 months, Patient´s subjective score of all treated nails (overall assessment) disregarding the little toenail at 1, 3, 6, 9 and 12 months, Terbinafine concentration in nail at 1, 3 and 6 months, Terbinafine concentration in plasma at 1 month;Primary end point(s): The primary objective of this trial is to compare efficacy and safety of two different treatment regimens of topical MOB015 in adults with DSO at 12 months. The primary efficacy variable is the proportion of patients with mycological cure of target nail, defined as negative fungal culture and negative direct microscopy, at 12 months.;Main Objective: The primary objective of this trial is to compare efficacy and safety of two different treatment regimens of topical MOB015 in adults with DSO at 12 months. The primary efficacy variable is the proportion of patients with mycological cure of target nail, defined as negative fungal culture and negative direct microscopy, at 12 months. | — |
Countries
Sweden
Outcome results
None listed