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

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.
 
ClinicalTrials.gov Identifier: NCT01246518
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : October 25, 2012
Sponsor:
Information provided by:
Moberg Pharma AB

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE November 23, 2010
Last Update Posted Date October 25, 2012
Study Start Date  ICMJE December 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
Proportion of patients with negative fungal culture, negative direct microscopy and complete cure. [ Time Frame: 1, 3, 6, 9, 12 months. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis
Official Title  ICMJE An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE Drug: MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
Study Arms  ICMJE
  • Active Comparator: MOB015 for 3 months
    Intervention: Drug: MOB015
  • Active Comparator: MOB015 for 9 months
    Intervention: Drug: MOB015
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01246518
Other Study ID Numbers  ICMJE MOB015-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kjell Rensfeldt MD, Moberg Derma AB
Study Sponsor  ICMJE Moberg Pharma AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Faergemann, MD, PhD Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden
PRS Account Moberg Pharma AB
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP