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

Phase 2

Completed

• Conditions: Distal Subungual Onychomycosis

• Registration Number: NCT01814020
• Lead Sponsor: Moberg Pharma AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-19
• Status Verified: 2013-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-09-19
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with mycological cure of the target nail,defined as negative fungal culture and negative direct microscopy at 60 weeks.	At 60 weeks

Trial Locations

Locations (1)

Hudkliniken Sahlgrenska Universitetssjukhuset; 🇸🇪 Gothenburg, Sweden