Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

Moberg Pharma

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: MOB015

Study type: Interventional

Funder types: Industry

Identifiers

NCT01246518

MOB015-I

Details and patient eligibility

About

Onychomycosis is a fungal infection that affects fingernails and/or toenails.

The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female
2. 18 - 70 years
3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization)
4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
5. Signed written informed consent

Exclusion criteria

1. Proximal subungual onychomycosis

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

3. "Spike" of onychomycosis extending to eponychium of the target nail

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

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

6. Topical antifungal treatment of the nails within 1 month before screening

7. Systemic use of antifungal treatment within 3 months before screening

8. Signs of severe peripheral circulatory insufficiency

9. Immunosuppression

10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening

11. Known allergy to any of the tested treatment products

12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)

13. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :

    • are pregnant or nursing
    • are not surgically sterile
    • are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

MOB015 for 3 months

Active Comparator group

Treatment:

Drug: MOB015

MOB015 for 9 months

Active Comparator group

Treatment:

Drug: MOB015