An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

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. Identifier: NCT01814020
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : September 22, 2014
Information provided by (Responsible Party):
Moberg Pharma AB

Brief Summary:
Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.

Condition or disease Intervention/treatment Phase
Distal Subungual Onychomycosis Drug: MOB015B Phase 2

Study Type : Interventional  (Clinical Trial)
Study Start Date : December 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Primary Outcome Measures :
  1. The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks. [ Time Frame: At 60 weeks ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.
  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. History or signs of peripheral circulatory insufficiency and/or diabetic neuropathy
  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 devices (IUD), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)

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 identifier (NCT number): NCT01814020

Hudkliniken Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, SE-413 45
Sponsors and Collaborators
Moberg Pharma AB

Responsible Party: Moberg Pharma AB Identifier: NCT01814020     History of Changes
Other Study ID Numbers: MOB015B/Final 30-Aug-2012
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: June 2013

Keywords provided by Moberg Pharma AB:

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases