Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

NCT01246518 | Completed Phase 2

• 1 other identifier: MOB015-I
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Onychomycosis is a fungal infection that affects fingernails and/or toenails. The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.

Conditions

Onychomycosis

Keywords

distal subungual onychomycosis

Outcome Measures

Primary Outcomes (1)

• Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.

  12 months

Secondary Outcomes (1)

• Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.

  1, 3, 6, 9, 12 months.

Study Arms (2)

MOB015 for 3 months

ACTIVE COMPARATOR

Drug: MOB015

MOB015 for 9 months

ACTIVE COMPARATOR

Drug: MOB015

Interventions

MOB015 DRUG

Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.

MOB015 for 3 months; MOB015 for 9 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• 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 (verified by blinded assessor before randomization)
• 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
• Signs of severe peripheral circulatory insufficiency
• 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)

15 Locations

Sweden, Sweden

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jan Faergemann, MD, PhD

  Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 23, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2011-09

Locations

SE (1)