Trial · NCT00750152
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris
NCT00750152, Phase 3, Completed, Merz North America, Inc.; results first posted 2012-03-13
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 Cruris. Trials, record NCT00750152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00750152
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 Cruris
- NCT number
- NCT00750152
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 334 participants, actual
- Lead sponsor
- Merz North America, Inc.
- Conditions
- Tinea Cruris, Jock Itch
- Interventions
- NAFT-500, Placebo
- First posted
- 2008-09-10
- Last updated
- 2013-04-22
- Results first posted
- 2012-03-13
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 | Week 4 post-baseline | Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done. |
| Secondary | Mycological Cure and Treatment Effectiveness | Week 4 (two weeks post-treatment) | Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4. |
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 | Week 4 post-baseline | The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment. | percentage of subjects with complete cur | NUMBER |
| SECONDARY | Mycological Cure and Treatment Effectiveness | Week 4 (two weeks post-treatment) | This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was 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 |
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 |
|---|---|---|---|---|---|
| Percentage of Subjects | NAFT-500 | 25.3 | percentage of subjects with complete cur | ||
| Percentage of Subjects | Placebo-2wks | 2.8 | percentage of subjects with complete cur | ||
| Mycological Cure and Treatment Effectiveness | NAFT-500 | Mycological Cure (MC) | 72.0 | percentage of subjects | |
| Mycological Cure and Treatment Effectiveness | Placebo-2wks | Mycological Cure (MC) | 15.5 | percentage of subjects | |
| Mycological Cure and Treatment Effectiveness | NAFT-500 | Treatment Effectiveness (TE) | 60.0 | percentage of subjects | |
| Mycological Cure and Treatment Effectiveness | Placebo-2wks | Treatment Effectiveness (TE) | 9.9 | 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-500 | 166 | |
| Overall Study | STARTED | Placebo-2wks | 168 | |
| Overall Study | COMPLETED | NAFT-500 | 144 | |
| Overall Study | COMPLETED | Placebo-2wks | 141 | |
| Overall Study | NOT COMPLETED | NAFT-500 | 22 | |
| Overall Study | NOT COMPLETED | Placebo-2wks | 27 |
Source ClinicalTrials.gov
Adverse events6
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 | Dyslipidaemia | Metabolism and nutrition disorders | NAFT-500 | 2 | 166 | |
| other | Dyslipidaemia | Metabolism and nutrition disorders | Placebo-2wks | 2 | 168 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | NAFT-500 | 0 | 166 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo-2wks | 4 | 168 | |
| other | Headache | Nervous system disorders | NAFT-500 | 2 | 166 | |
| other | Headache | Nervous system disorders | Placebo-2wks | 4 | 168 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NAFT-500 | ||
| Total, all-cause mortality | Placebo-2wks | ||
| Total, other adverse events | NAFT-500 | 4 | 166 |
| Total, other adverse events | Placebo-2wks | 10 | 168 |
| Total, serious adverse events | NAFT-500 | 0 | 166 |
| Total, serious adverse events | Placebo-2wks | 0 | 168 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21968664 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NAFT-500 vs Placebo-2wks: 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/NCT00750152
GET https://conductscience.org/api/trials/v1/NCT00750152/registered