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

Distal Subungual Onychomycosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814020
• Other study ID #: MOB015B/Final 30-Aug-2012
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2013
• Last updated: September 19, 2014
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: June 2013
• Source: Moberg Derma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Distal Subungual Onychomycosis
• Onychomycosis

Intervention

Drug:
• MOB015B

Locations

Country	Name	City	State
Sweden	Hudkliniken Sahlgrenska Universitetssjukhuset	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Moberg Derma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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