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

October 24, 2012 updated by: Moberg Pharma AB

An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Sweden, Sweden
        • 15 Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 (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

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. 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MOB015 for 3 months
Drug: MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
Active Comparator: MOB015 for 9 months
Drug: MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.
Time Frame: 1, 3, 6, 9, 12 months.
1, 3, 6, 9, 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moberg Pharma AB

Investigators

  • Principal Investigator: Jan Faergemann, MD, PhD, Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOB015-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe