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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)

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ClinicalTrials.gov Identifier: NCT02859519
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Moberg Pharma AB

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.


Condition or disease Intervention/treatment Phase
Distal Subungual Onychomycosis Drug: MOB015B Drug: MOB015B Vehicle Phase 3

Detailed Description:

Male or female subjects aged between 12 and 75 years with confirmed DSO involving 20-60% of at least one great toenail will be screened for randomization in this study. The diagnosis of DSO will be confirmed prior to randomization through a positive culture of dermatophytes. In addition, a central blinded assessment of the clinical disease involvement (i.e., affected nail area) will be performed at Screening. Subjects have to meet all eligibility criteria before being randomized in to the study.

Eligible subjects will be randomized to the investigational medicinal products (MOB015B or vehicle) in a ratio of 2:1. The investigational medicinal products (IMPs) will be applied to all affected fingernails and/or toenails for 48 weeks once daily at bedtime. However, fingernails will not be assessed for efficacy.

Since both the IMPs are indistinguishable in appearance and mode of administration, the study will be performed as a double-blind study, i.e., both the investigator and the subject will remain blinded throughout the entire study.

After a 4-week follow-up period without IMP treatment the end of study (EoS) Visit will be performed at Week 52 (Visit 7). The primary efficacy variable will be assessed at Week 52. The end of the clinical study for each individual subject is defined as the EoS Visit at Week 52 (Visit 7). The end of the clinical study is defined as the last visit of the last subject in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 13, 2019
Actual Study Completion Date : November 13, 2019

Arm Intervention/treatment
Experimental: MOB015B
Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime.
Drug: MOB015B
MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution

Placebo Comparator: MOB015B Vehicle
Subjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime.
Drug: MOB015B Vehicle
MOB015B Vehicle without the active ingredient Terbinafine




Primary Outcome Measures :
  1. Subjects with complete cure of the target toe nail at Week 52 [ Time Frame: Week 52 ]
    Complete cure was defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide (KOH) microscopy and 0% clinical disease involvement of the target toenail.


Secondary Outcome Measures :
  1. Subjects with mycological cure of the target toe nail at Week 52 [ Time Frame: Week 52 ]
    Mycological cure was defined as negative fungal culture of dermatophytes and negative direct KOH microscopy of the target toenail.

  2. Subjects with treatment success of the target toe nail at Week 52 [ Time Frame: Week 52 ]
    Treatment success was defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and ≤10% clinical disease involvement of the target toenail.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859519


Locations
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United States, California
Multiple Locations, California, United States
United States, Florida
Multiple Locations, Florida, United States
United States, Idaho
Multiple Locations, Idaho, United States
United States, Illinois
Rolling Meadows, Illinois, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, New Jersey
Multiple Locations, New Jersey, United States
United States, Oregon
Multiple Locations, Oregon, United States
United States, Texas
Multiple Locations, Texas, United States
United States, Virginia
Multiple Locations, Virginia, United States
Canada
Multiple Locations, Canada
Sponsors and Collaborators
Moberg Pharma AB
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Responsible Party: Moberg Pharma AB
ClinicalTrials.gov Identifier: NCT02859519    
Other Study ID Numbers: MOB015B-IV
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases