A Multi-centre, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

• Status: Completed
• Trial end date: 2019-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moberg Pharma AB

Criteria

Inclusion Criteria:

1. Males or females 12 - 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. 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 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 at Baseline/Visit 2 indicating pregnancy in a woman of childbearing potential or a premenarche subject

18. Females who are pregnant or breastfeeding

19. Men who have female sexual partners of child-bearing potential and sexually active women of child-bearing potential who are not practicing an acceptable method of birth control, or who will not remain abstinent through 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