An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

NCT01814020 | Completed Phase 2

• 1 other identifier: MOB015B/Final 30-Aug-2012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.

Conditions

Distal Subungual Onychomycosis

Keywords

DSO

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.

  At 60 weeks

Interventions

MOB015B DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (1)

Hudkliniken Sahlgrenska Universitetssjukhuset

Gothenburg, SE-413 45, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2013-06

Locations

SE (1)