An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
Primary Purpose
Distal Subungual Onychomycosis
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
MOB015B
Sponsored by
About this trial
This is an interventional trial for Distal Subungual Onychomycosis focused on measuring DSO
Eligibility Criteria
Inclusion Criteria:
- Male or female
- 18 - 70 years
- DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail.
- Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
- Signed written informed consent
Exclusion Criteria:
- Proximal subungual onychomycosis.
- 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)
- "Spike" of onychomycosis extending to eponychium of the target nail
- 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
- Other conditions than DSO known to cause abnormal nail appearance
- Topical antifungal treatment of the nails within 1 month before screening
- Systemic use of antifungal treatment within 3 months before screening
- History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
- Immunosuppression
- Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
- Known allergy to any of the tested treatment products
- A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
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)
Sites / Locations
- Hudkliniken Sahlgrenska Universitetssjukhuset
Outcomes
Primary Outcome Measures
The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01814020
Brief Title
An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moberg Pharma AB
4. Oversight
5. Study Description
Brief Summary
Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Subungual Onychomycosis
Keywords
DSO
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MOB015B
Primary Outcome Measure Information:
Title
The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.
Time Frame
At 60 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Male or female
18 - 70 years
DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail.
Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
Signed written informed consent
Exclusion Criteria:
Proximal subungual onychomycosis.
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)
"Spike" of onychomycosis extending to eponychium of the target nail
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
Other conditions than DSO known to cause abnormal nail appearance
Topical antifungal treatment of the nails within 1 month before screening
Systemic use of antifungal treatment within 3 months before screening
History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
Immunosuppression
Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
Known allergy to any of the tested treatment products
A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
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)
Facility Information:
Facility Name
Hudkliniken Sahlgrenska Universitetssjukhuset
City
Gothenburg
ZIP/Postal Code
SE-413 45
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)
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