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

An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01246518

Enrollment

250

Registered

2010-11-23

Start date

2010-12-31

Completion date

2012-10-31

Last updated

2012-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Keywords

distal subungual onychomycosis

Brief summary

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.

Interventions

DRUGMOB015

Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.	12 months

Secondary

Measure	Time frame
Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.	1, 3, 6, 9, 12 months.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026