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

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

Study Overview

• Status: Completed
• Conditions: Distal Subungual Onychomycosis
• Intervention / Treatment: Drug: MOB015B

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-413 45
    • Hudkliniken Sahlgrenska Universitetssjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Moberg Pharma AB

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): September 22, 2014
• Last Update Submitted That Met QC Criteria: September 19, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: DSO
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: MOB015B/Final 30-Aug-2012