A Phase 2 interventional study of NVXT Solution and Vehicle of test product in Onychomycosis, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-19.
Sponsored by Taro Pharmaceuticals USA · Phase 2, Interventional, and Treatment
This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 47 is close to the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NVXT Solution once daily for 60 days
Drug: NVXT Solution
Vehicle of test product, once daily for 60 days
Drug: Vehicle of test product
NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Also known as: NVXT
Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
Also known as: Placebo
Number of Participants With Negative Fungal Culture
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
Time frame: 28 days
| Milestone | NVXT Solution | Vehicle of Test Product |
|---|---|---|
| Started | 35 | 12 |
| Completed | 23 | 11 |
| Not completed | 12 | 1 |
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
| Participants | NVXT Solution | Vehicle of Test Product |
|---|---|---|
| Number of Participants With Negative Fungal Culture | 14 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NVXT Solution | — | 0/35 (0%) | 7/35 (20%) |
| Vehicle of Test Product | — | 0/12 (0%) | 3/12 (25%) |
| Event | NVXT Solution | Vehicle of Test Product |
|---|---|---|
| HypertensionVascular disorders | 0/35 | 1/12 |
| PharangitisRespiratory, thoracic and mediastinal disorders | 0/35 | 1/12 |
| Muscle SpasmMusculoskeletal and connective tissue disorders | 0/35 | 1/12 |
| Common ColdRespiratory, thoracic and mediastinal disorders | 2/35 | 0/12 |
| Abdominal PainGastrointestinal disorders | 1/35 | 0/12 |
| SinusitisRespiratory, thoracic and mediastinal disorders | 1/35 | 0/12 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/35 | 0/12 |
| Exacerbation of Tinea PedisSkin and subcutaneous tissue disorders | 1/35 | 0/12 |
| RashSkin and subcutaneous tissue disorders | 1/35 | 0/12 |
| Age, Categorical(Participants) | NVXT Solution | Vehicle of Test Product | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 12 | 47 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | NVXT Solution | Vehicle of Test Product | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 30 | 11 | 41 |
| Race (NIH/OMB)(Participants) | NVXT Solution | Vehicle of Test Product | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 5 | 14 |
| White | 21 | 5 | 26 |
| More than one race | 5 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Taro Pharmaceuticals USA