An open, single-centre pilot study of efficacy and safety of topical MOB015B in the treatment of distal subungual onychomycosis (DSO)

Phase 1

• Conditions: Distal subungual onychomycosis (DSO); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003722-24-SE
• Lead Sponsor: Moberg Derma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-06
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this trial are to evaluate efficacy and safety of topical MOB015B in adults with DSO at 60 weeks.;Secondary Objective: Not applicable;Primary end point(s): The proportion of patients with mycological cure of the target nail, defined as negative fungal culture and negative direct microscopy.;Timepoint(s) of evaluation of this end point: At 60 weeks