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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246518
First Posted: November 23, 2010
Last Update Posted: October 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Moberg Pharma AB
  Purpose

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.


Condition Intervention Phase
Onychomycosis Drug: MOB015 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)

Further study details as provided by Moberg Pharma AB:

Primary Outcome Measures:
  • Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy. [ Time Frame: 12 months ]

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

Estimated Enrollment: 250
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246518


Locations
Sweden
15 Locations
Sweden, Sweden
Sponsors and Collaborators
Moberg Pharma AB
Investigators
Principal Investigator: Jan Faergemann, MD, PhD Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden
  More Information

Responsible Party: Kjell Rensfeldt MD, Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01246518     History of Changes
Other Study ID Numbers: MOB015-I
First Submitted: November 19, 2010
First Posted: November 23, 2010
Last Update Posted: October 25, 2012
Last Verified: September 2011

Keywords provided by Moberg Pharma AB:
distal subungual onychomycosis

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases