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

NCT ID: NCT02866032

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-06-10

Brief 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.

Conditions

Distal Subungual Onychomycosis

Study Groups

MOB015B

Group Type: EXPERIMENTAL

MOB015B

Intervention Type: DRUG

Ciclopirox 80 mg/g

Group Type: ACTIVE_COMPARATOR

Ciclopirox 80 mg/g

Intervention Type: DRUG

Interventions

MOB015B

Intervention Type: DRUG

Ciclopirox 80 mg/g

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moberg Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Multiple Locations, , Germany

Multiple Locations, , Poland

Multiple Locations, , United Kingdom

Countries

Germany; Poland; United Kingdom

Other Identifiers

MOB015B-III

Identifier Type: -

Identifier Source: org_study_id