Trial · NCT01290341
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
NCT01290341, Phase 3, Completed, Merz North America, Inc.; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis. Trials, record NCT01290341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01290341
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
- NCT number
- NCT01290341
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 860 participants, actual
- Lead sponsor
- Merz North America, Inc.
- Conditions
- Tinea Pedis
- Interventions
- NAFT-600 (naftin 2 % gel), Placebo
- First posted
- 2011-02-07
- Last updated
- 2013-09-26
- Results first posted
- 2013-09-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Cure of Interdigital Tinea Pedis | Visit 4/ Week 6 | The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus. |
| Secondary | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Visit 4/ Week 6 | Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Cure of Interdigital Tinea Pedis | Visit 4/ Week 6 | Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment. | percentage of subjects | NUMBER |
| SECONDARY | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Visit 4/ Week 6 | Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Cure of Interdigital Tinea Pedis | NAFT-600 | 26.0 | percentage of subjects | ||
| Complete Cure of Interdigital Tinea Pedis | Placebo | 3.3 | percentage of subjects | ||
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | NAFT-600 | Mycological Cure | 58.8 | percentage of subjects | |
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Placebo | Mycological Cure | 10.3 | percentage of subjects | |
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | NAFT-600 | Effective Treatment | 50.8 | percentage of subjects | |
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Placebo | Effective Treatment | 7.0 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NAFT-600 | 573 | |
| Overall Study | STARTED | Placebo | 287 | |
| Overall Study | COMPLETED | NAFT-600 | 481 | |
| Overall Study | COMPLETED | Placebo | 258 | |
| Overall Study | NOT COMPLETED | NAFT-600 | 92 | |
| Overall Study | NOT COMPLETED | Placebo | 29 |
Source ClinicalTrials.gov
Adverse events8
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 |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | NAFT-600 | 16 | 572 | |
| other | Headache | Nervous system disorders | Placebo | 5 | 287 | |
| serious | Urethral Stenosis | Renal and urinary disorders | NAFT-600 | 1 | 572 | |
| serious | Urethral Stenosis | Renal and urinary disorders | Placebo | 0 | 287 | |
| serious | Appendicitis | Infections and infestations | NAFT-600 | 0 | 572 | |
| serious | Appendicitis | Infections and infestations | Placebo | 1 | 287 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | NAFT-600 | 0 | 572 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | Placebo | 1 | 287 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NAFT-600 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | NAFT-600 | 16 | 572 |
| Total, other adverse events | Placebo | 5 | 287 |
| Total, serious adverse events | NAFT-600 | 1 | 572 |
| Total, serious adverse events | Placebo | 2 | 287 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NAFT-600 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01290341
GET https://conductscience.org/api/trials/v1/NCT01290341/registered