An open, multi-centre trial comparing the efficacy and safety of two different treatment regimens of topical MOB015 treatment of distal subungual onychomycosis (DSO)
- Conditions
- Distal subungual onychomycosis (DSO)MedDRA version: 12.1Level: LLTClassification code 10030338Term: Onychomycosis
- Registration Number
- EUCTR2010-022622-32-SE
- Lead Sponsor
- Moberg Derma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method