Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Distal Subungual Onychomycosis Clinical Trial

Official title:

A Multi-centre, Randomized, Two-armed, Parallel Group and Evaluator-blinded Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866032
• Other study ID #: MOB015B-III
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: June 10, 2020

Study information

• Verified date: October 2020
• Source: Moberg Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate distal subungual onychomycosis (DSO).

The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: June 10, 2020
• Est. primary completion date: June 10, 2020
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Males or females 18 - 75 years of age

2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail

3. Positive culture for dermatophytes

4. Signed written informed consent

Exclusion Criteria:

1. Proximal subungual onychomycosis

2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)

3. Target toenail thickness more than 3 mm

4. "Spike" of onychomycosis extending to eponychium of the target toenail

5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail

6. Other conditions than DSO known to cause abnormal nail appearance

7. Presence of toenail infection other than dermatophytes

8. Previous target toenail surgery with any residual disfigurement

9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before screening/Visit 1

10. Systemic use of antifungal treatment within 6 months before screening/ Visit 1

11. Severe moccasin tinea pedis

12. Signs of severe peripheral circulatory insufficiency

13. Uncontrolled diabetes mellitus

14. Known immunodeficiency

15. Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2

16. Known allergy to any of the tested treatment products

17. A positive pregnancy test indicating pregnancy in a woman of childbearing potential at Baseline/ Visit 2

18. Females who are pregnant or breastfeeding

19. Pre-menopausal (last menstruation = 1 year prior to screening) sexually active women who are of childbearing potential and are not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial

20. Patients previously randomized in this study

21. History of, or current drug or alcohol abuse

22. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient's ability to completely understand the consequences of consent is missing

23. Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor's company

24. Patients who are institutionalized because of legal or regulatory order

25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Related Conditions & MeSH terms

• Distal Subungual Onychomycosis
• Onychomycosis

Intervention

Drug:
• MOB015B

• Ciclopirox 80 mg/g

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moberg Pharma AB

Countries where clinical trial is conducted

Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete cure of the target nail defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement at Week 52		Week 52