Trial · NCT00804193

Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis

NCT00804193, Not applicable, Completed, Padagis LLC; results first posted 2012-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis. Trials, record NCT00804193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00804193

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 Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis
NCT number: NCT00804193
Status: Completed
Phases: Not applicable
Enrollment: 553 participants, actual
Lead sponsor: Padagis LLC
Conditions: Tinea Pedis
Interventions: Ciclopirox Olamine Topical Suspension, Ciclopirox Topical Suspension 0.77%-Reference Product, Ciclopirox Olamine Topical Suspension-Placebo
First posted: 2008-12-08
Last updated: 2021-10-27
Results first posted: 2012-12-17

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	Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
Secondary	Proportion of Subjects With Mycological Cure	6 weeks	Potassium hydroxide \[KOH\] 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		participants	NUMBER
SECONDARY	Proportion of Subjects With Clinical Cure	6 weeks		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	Value	Units
Proportion of Subjects in Each Treatment Group With Therapeutic Success	Test Product	93	participants
Proportion of Subjects in Each Treatment Group With Therapeutic Success	Reference Product	88	participants
Proportion of Subjects in Each Treatment Group With Therapeutic Success	Vehicle Product	7	participants
Proportion of Subjects With Mycological Cure	Test Product	119	participants
Proportion of Subjects With Mycological Cure	Reference Product	127	participants
Proportion of Subjects With Mycological Cure	Vehicle Product	18	participants
Proportion of Subjects With Clinical Cure	Test Product	81	participants
Proportion of Subjects With Clinical Cure	Reference Product	96	participants
Proportion of Subjects With Clinical Cure	Vehicle Product	22	participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Test Product	220
Overall Study	STARTED	Reference Product	224
Overall Study	STARTED	Vehicle Product	109
Overall Study	COMPLETED	Test Product	181
Overall Study	COMPLETED	Reference Product	180
Overall Study	COMPLETED	Vehicle Product	77
Overall Study	NOT COMPLETED	Test Product	39
Overall Study	NOT COMPLETED	Reference Product	44
Overall Study	NOT COMPLETED	Vehicle Product	32

Source ClinicalTrials.gov

Adverse events18

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	Chest pain	Cardiac disorders	Test Product	0	220	0
serious	Chest pain	Cardiac disorders	Reference Product	0	224	0
serious	Chest pain	Cardiac disorders	Vehicle Product	1	109	1
serious	Perforated sigmoid colon	Gastrointestinal disorders	Test Product	0	220	0
serious	Perforated sigmoid colon	Gastrointestinal disorders	Reference Product	1	224	1
serious	Perforated sigmoid colon	Gastrointestinal disorders	Vehicle Product	0	109	0
serious	Subarachnoid hemorrhage; MCA aneurysm; PCOM	Nervous system disorders	Test Product	0	220	0
serious	Subarachnoid hemorrhage; MCA aneurysm; PCOM	Nervous system disorders	Reference Product	0	224	0
serious	Subarachnoid hemorrhage; MCA aneurysm; PCOM	Nervous system disorders	Vehicle Product	1	109	1
serious	Blood clots spleen	Gastrointestinal disorders	Test Product	0	220	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse 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	220
Total, other adverse events	Reference Product	0	224
Total, other adverse events	Vehicle Product	0	109
Total, serious adverse events	Test Product	0	220
Total, serious adverse events	Reference Product	2	224
Total, serious adverse events	Vehicle Product	4	109

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00804193

GET https://conductscience.org/api/trials/v1/NCT00804193/registered

API reference For AI assistants