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

Primary Purpose

Distal Subungual Onychomycosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MOB015B
Ciclopirox 80 mg/g
Sponsored by
Moberg Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Distal Subungual Onychomycosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MOB015B

Ciclopirox 80 mg/g

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2016
Last Updated
October 5, 2020
Sponsor
Moberg Pharma AB
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1. Study Identification

Unique Protocol Identification Number
NCT02866032
Brief Title
Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moberg Pharma AB

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Subungual Onychomycosis

7. Study Design

Study Phase
Phase 3
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOB015B
Arm Type
Experimental
Arm Title
Ciclopirox 80 mg/g
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MOB015B
Intervention Type
Drug
Intervention Name(s)
Ciclopirox 80 mg/g
Primary Outcome Measure Information:
Title
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
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria: Males or females 18 - 75 years of age Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail Positive culture for dermatophytes Signed written informed consent Exclusion Criteria: Proximal subungual onychomycosis 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) Target toenail thickness more than 3 mm "Spike" of onychomycosis extending to eponychium of the target toenail Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail Other conditions than DSO known to cause abnormal nail appearance Presence of toenail infection other than dermatophytes Previous target toenail surgery with any residual disfigurement Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before screening/Visit 1 Systemic use of antifungal treatment within 6 months before screening/ Visit 1 Severe moccasin tinea pedis Signs of severe peripheral circulatory insufficiency Uncontrolled diabetes mellitus Known immunodeficiency Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2 Known allergy to any of the tested treatment products A positive pregnancy test indicating pregnancy in a woman of childbearing potential at Baseline/ Visit 2 Females who are pregnant or breastfeeding 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 Patients previously randomized in this study History of, or current drug or alcohol abuse 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 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 Patients who are institutionalized because of legal or regulatory order Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Facility Information:
City
Multiple Locations
Country
Germany
City
Multiple Locations
Country
Poland
City
Multiple Locations
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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