Phase 2
Completed N=184
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
Onychomycosis
Source: ClinicalTrials.gov NCT02933879 ↗
Enrolled (actual)
184
Serious AEs
0.5%
Results posted
Dec 2018
Primary outcomePrimary: Number of Patients in Each Treatment Group With a Complete Therapeutic Cure — 1; 0; 1 Participants — p=0.4615
Summary
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Each Treatment Group With a Complete Therapeutic Cure |
0; 1 | — |
| SECONDARY Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure |
1; 1 | — |
| SECONDARY Number of Patients in Each Treatment Group With a Mycological Cure |
30; 10 | — |
| SECONDARY Number of Patients in Each Treatment Group With a Complete Clinical Cure |
0; 1 | — |
| SECONDARY Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure |
2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).
Exclusion Criteria
- Females who are pregnant, lactating or likely to become pregnant during the study.
Data sourced from ClinicalTrials.gov (NCT02933879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.