Trial · NCT00750139
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
NCT00750139, Phase 3, Completed, Merz North America, Inc.; results first posted 2013-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis. Trials, record NCT00750139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00750139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
- NCT number
- NCT00750139
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 707 participants, actual
- Lead sponsor
- Merz North America, Inc.
- Conditions
- Tinea Pedis, Athlete's Foot
- Interventions
- NAFT-500, Placebo 2-weeks, Naftin 1%, Placebo 4-weeks
- First posted
- 2008-09-10
- Last updated
- 2013-04-26
- Results first posted
- 2013-01-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Complete Cure at Week 6. | Week 6 | The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6. The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6. Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale. |
| Secondary | Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | Week 6 | Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6. |
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 | Percentage of Subjects With Complete Cure at Week 6. | Week 6 | This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment. | percentage of subjects with complete cur | NUMBER |
| SECONDARY | Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | Week 6 | This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment. | percentage of Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Complete Cure at Week 6. | NAFT-500 | 17.7 | percentage of subjects with complete cur | ||
| Percentage of Subjects With Complete Cure at Week 6. | Placebo 2-weeks | 7.1 | percentage of subjects with complete cur | ||
| Percentage of Subjects With Complete Cure at Week 6. | Naftin 1% | 16.1 | percentage of subjects with complete cur | ||
| Percentage of Subjects With Complete Cure at Week 6. | Placebo 4-wks | 3.1 | percentage of subjects with complete cur | ||
| Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | NAFT-500 | Mycological Cure (MC) | 67.3 | percentage of Subjects | |
| Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | Placebo 2-wks | Mycological Cure (MC) | 21.4 | percentage of Subjects | |
| Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | Naftin 1% | Mycological Cure (MC) | 71.3 | percentage of Subjects | |
| Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | Placebo 4-wks | Mycological Cure (MC) | 21.5 | percentage of Subjects | |
| Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | NAFT-500 | Treatment Effectiveness (TE) | 56.5 | percentage of Subjects | |
| Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 | Placebo 2-wks | Treatment Effectiveness (TE) | 20.0 | percentage of Subjects |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NAFT-500 | 234 | |
| Overall Study | STARTED | Placebo 2-wks | 118 | |
| Overall Study | STARTED | Naftin 1% | 236 | |
| Overall Study | STARTED | Placebo 4-wks | 119 | |
| Overall Study | COMPLETED | NAFT-500 | 145 | |
| Overall Study | COMPLETED | Placebo 2-wks | 59 | |
| Overall Study | COMPLETED | Naftin 1% | 135 | |
| Overall Study | COMPLETED | Placebo 4-wks | 73 | |
| Overall Study | NOT COMPLETED | NAFT-500 | 89 | |
| Overall Study | NOT COMPLETED | Placebo 2-wks | 59 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
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-500 | 10 | 234 | |
| other | Headache | Nervous system disorders | Placebo 2-wks | 4 | 118 | |
| other | Headache | Nervous system disorders | Naftin 1% | 9 | 236 | |
| other | Headache | Nervous system disorders | Placebo 4-wks | 3 | 119 | |
| other | Nasopharyngitis | Infections and infestations | NAFT-500 | 3 | 234 | |
| other | Nasopharyngitis | Infections and infestations | Placebo 2-wks | 2 | 118 | |
| other | Nasopharyngitis | Infections and infestations | Naftin 1% | 5 | 236 | |
| other | Nasopharyngitis | Infections and infestations | Placebo 4-wks | 4 | 119 | |
| other | Application Site Irritation | General disorders | NAFT-500 | 4 | 234 | |
| other | Application Site Irritation | General disorders | Placebo 2-wks | 3 | 118 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NAFT-500 | ||
| Total, all-cause mortality | Placebo 2-wks | ||
| Total, all-cause mortality | Naftin 1% | ||
| Total, all-cause mortality | Placebo 4-wks | ||
| Total, other adverse events | NAFT-500 | 38 | 234 |
| Total, other adverse events | Placebo 2-wks | 22 | 118 |
| Total, other adverse events | Naftin 1% | 31 | 236 |
| Total, other adverse events | Placebo 4-wks | 26 | 119 |
| Total, serious adverse events | NAFT-500 | 0 | 234 |
| Total, serious adverse events | Placebo 2-wks | 0 | 118 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22052309 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00750139
GET https://conductscience.org/api/trials/v1/NCT00750139/events?page=2