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

This study has been completed.
Sponsor:
Information provided by:
Moberg Derma AB
ClinicalTrials.gov Identifier:
NCT01246518
First received: November 19, 2010
Last updated: October 24, 2012
Last verified: September 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Moberg Derma 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with negative fungal culture, negative direct microscopy and complete cure. [ Time Frame: 1, 3, 6, 9, 12 months. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246518

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

No publications provided

Responsible Party: Kjell Rensfeldt MD, Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01246518     History of Changes
Other Study ID Numbers: MOB015-I
Study First Received: November 19, 2010
Last Updated: October 24, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Moberg Derma AB:
distal subungual onychomycosis

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

ClinicalTrials.gov processed this record on July 24, 2014