Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

Onychomycosis Clinical Trial

Official title:

An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246518
• Other study ID #: MOB015-I
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2010
• Last updated: October 24, 2012
• Start date: December 2010
• Est. completion date: October 2012

Study information

• Verified date: September 2011
• Source: Moberg Derma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Onychomycosis is a fungal infection that affects fingernails and/or toenails.

The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• 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 (verified by blinded assessor before randomization)

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. Signs of severe peripheral circulatory insufficiency

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.

Locations

Country	Name	City	State
Sweden	15 Locations	Sweden

Sponsors (1)

Lead Sponsor	Collaborator
Moberg Derma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.		12 months	No
Secondary	Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.		1, 3, 6, 9, 12 months.	No