Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
NCT07929844, Phase 2, Not yet recruiting, SATO Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis | ClinicalTrials.gov |
| NCT number | NCT07929844 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 204 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | SATO Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Onychomycosis of Toenails | ClinicalTrials.gov |
| Interventions | SKX-16 (Luliconazole 10% Solution), Vehicle solution | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Complete Cure at Week 56 | 56 weeks | Proportion of participants who achieve Complete Cure of the target toenail at Week 56, as defined by clinical cure (completely clear target great toenail as assessed by the investigator) and mycological cure (negative KOH microscopy and negative culture) | ClinicalTrials.gov |
| Secondary | Mycological Cure at Week 56 | 56 weeks | Proportion of participants with mycological cure (negative KOH microscopy and negative culture) of the target toenail at Week 56 | ClinicalTrials.gov |
| Secondary | Clinical Cure at Week 56 | 56 weeks | Proportion of participants with clinical cure (completely clear target great toenail as assessed by the investigator) at Week 56 | ClinicalTrials.gov |
| Secondary | ≤5% Affected Nail Area + Mycological Cure at Week 56 | 56 weeks | Proportion of participants with ≤ 5% of affected target toenail area and mycological cure of the target toenail at Week 56 | ClinicalTrials.gov |
| Secondary | <10% Affected Nail Area + Mycological Cure at Week 56 | 56 weeks | Proportion of participants with \< 10% of affected target toenail area and mycological cure of the target toenail at Week 56 | ClinicalTrials.gov |
| Secondary | Percent Change in Affected Nail Area | Baseline and Week 56 | Percent change from baseline in percentage of affected target toenail area at Week 56 | ClinicalTrials.gov |
| Secondary | Clear Nail Growth at Week 56 | 56 weeks | Clear nail growth of the target toenail at Week 56 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)