Trial · NCT00802672
Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
NCT00802672, Phase 3, Completed, Padagis LLC; results first posted 2012-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis. Trials, record NCT00802672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00802672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
- NCT number
- NCT00802672
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 561 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Tinea Pedis
- Interventions
- Ciclopirox Olamine Cream, Loprox Cream 0.77%, Placebo
- First posted
- 2008-12-05
- Last updated
- 2021-10-13
- Results first posted
- 2012-06-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects in Each Treatment Group With Therapeutic Success | 6 weeks | Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success |
| Secondary | Proportion of Subjects With Mycological Cure | 6 weeks | Mycological Cure (KOH wet mount negative and fungal culture negative |
| Secondary | Proportion of Subjects With Clinical Cure | 6 weeks | Clinical Cure was defined as a signs and symptoms score of \<1 for erythema; \<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects in Each Treatment Group With Therapeutic Success | 6 weeks | Per protocol population | participants | NUMBER |
| SECONDARY | Proportion of Subjects With Mycological Cure | 6 weeks | per protocol population | participants | NUMBER |
| SECONDARY | Proportion of Subjects With Clinical Cure | 6 weeks | per protocol population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | Test Product | 70 | participants | ||
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | Reference Product | 95 | participants | ||
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | Vehicle Product | 3 | participants | ||
| Proportion of Subjects With Mycological Cure | Test Product | 107 | participants | ||
| Proportion of Subjects With Mycological Cure | Reference Product | 133 | participants | ||
| Proportion of Subjects With Mycological Cure | Vehicle Product | 9 | participants | ||
| Proportion of Subjects With Clinical Cure | Test Product | 82 | participants | ||
| Proportion of Subjects With Clinical Cure | Reference Product | 106 | participants | ||
| Proportion of Subjects With Clinical Cure | Vehicle Product | 9 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Product | 224 | |
| Overall Study | STARTED | Reference Product | 226 | |
| Overall Study | STARTED | Vehicle Product | 111 | |
| Overall Study | COMPLETED | Test Product | 156 | |
| Overall Study | COMPLETED | Reference Product | 174 | |
| Overall Study | COMPLETED | Vehicle Product | 77 | |
| Overall Study | NOT COMPLETED | Test Product | 68 | |
| Overall Study | NOT COMPLETED | Reference Product | 52 | |
| Overall Study | NOT COMPLETED | Vehicle Product | 34 |
Source ClinicalTrials.gov
Adverse events15
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 |
|---|---|---|---|---|---|---|
| serious | Pain secondary to head trauma | General disorders | Test Product | 1 | 224 | 1 |
| serious | Pain secondary to head trauma | General disorders | Reference Product | 0 | 226 | 0 |
| serious | Pain secondary to head trauma | General disorders | Vehicle Product | 0 | 111 | 0 |
| serious | Near syncope | Cardiac disorders | Test Product | 0 | 224 | 0 |
| serious | Near syncope | Cardiac disorders | Reference Product | 1 | 226 | 1 |
| serious | Near syncope | Cardiac disorders | Vehicle Product | 0 | 111 | 0 |
| serious | pneumonia | Respiratory, thoracic and mediastinal disorders | Test Product | 0 | 224 | 0 |
| serious | pneumonia | Respiratory, thoracic and mediastinal disorders | Reference Product | 1 | 226 | 1 |
| serious | pneumonia | Respiratory, thoracic and mediastinal disorders | Vehicle Product | 0 | 111 | 0 |
| serious | congestive heart failure | Cardiac disorders | Test Product | 0 | 224 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Product | ||
| Total, all-cause mortality | Reference Product | ||
| Total, all-cause mortality | Vehicle Product | ||
| Total, other adverse events | Test Product | 0 | 0 |
| Total, other adverse events | Reference Product | 0 | 0 |
| Total, other adverse events | Vehicle Product | 0 | 0 |
| Total, serious adverse events | Test Product | 2 | 224 |
| Total, serious adverse events | Reference Product | 2 | 226 |
| Total, serious adverse events | Vehicle Product | 1 | 111 |
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 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/NCT00802672
GET https://conductscience.org/api/trials/v1/NCT00802672/registered