NCT00804193 is a NA clinical trial of Ciclopirox Olamine Topical Suspension in Tinea Pedis, sponsored by Padagis LLC.

Who is sponsoring NCT00804193?

NCT00804193 is sponsored by Padagis LLC.

What drugs are being tested in NCT00804193?

Interventions in NCT00804193: Ciclopirox Olamine Topical Suspension, Ciclopirox Topical Suspension 0.77%-Reference Product, Ciclopirox Olamine Topical Suspension-Placebo.

What condition does NCT00804193 study?

NCT00804193 studies Tinea Pedis.

Is NCT00804193 still recruiting?

NCT00804193 is currently completed. Last updated 11 October 2021.

Are results published for NCT00804193?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-11 · How we verify

NCT00804193

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis

Completed NA Results posted Last updated 11 October 2021

What this trial tests

NA trial testing Ciclopirox Olamine Topical Suspension in Tinea Pedis in 553 participants. Completed in 1 April 2005.

Timeline

1 June 2004

Primary endpoint
1 December 2004

1 April 2005

Quick facts

Lead sponsor	Padagis LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	553
Start date	1 June 2004
Primary completion	1 December 2004
Estimated completion	1 April 2005

Drugs / interventions tested

Ciclopirox Olamine Topical Suspension — full drug profile →
Ciclopirox Topical Suspension 0.77%-Reference Product — full drug profile →
Ciclopirox Olamine Topical Suspension-Placebo — full drug profile →

Conditions studied

Tinea Pedis — all drugs for Tinea Pedis →

Sponsor

Padagis LLC — full company profile →

Who can join

10 and older, any sex, with Tinea Pedis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of Subjects in Each Treatment Group With Therapeutic Success
Time frame: 6 weeks
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure

Sponsor's own description

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tinea Pedis

Currently open trials in the same condition.

NCT07056660 — Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis · NA · recruiting

Other Padagis LLC trials

Trials by the same sponsor.

NCT05763082 — Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis · Phase 3 · completed
NCT04944290 — To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocul · Phase 3 · completed
NCT04155203 — To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infe · Phase 3 · completed
NCT04024072 — To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocul · Phase 3 · completed
NCT03393494 — Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00804193 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Padagis LLC
Last refreshed: 11 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00804193.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing