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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Moberg Derma AB
ClinicalTrials.gov Identifier:
NCT01814020
First received: March 15, 2013
Last updated: September 19, 2014
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Distal Subungual Onychomycosis
Drug: MOB015B
Phase 2

Study Type: Interventional

Further study details as provided by Moberg Derma AB:

Primary Outcome Measures:
  • 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 ]

Study Start Date: December 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01814020

Locations
Sweden
Hudkliniken Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, SE-413 45
Sponsors and Collaborators
Moberg Derma AB
  More Information

No publications provided

Responsible Party: Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01814020     History of Changes
Other Study ID Numbers: MOB015B/Final 30-Aug-2012
Study First Received: March 15, 2013
Last Updated: September 19, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Moberg Derma AB:
DSO

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

ClinicalTrials.gov processed this record on October 23, 2014