Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT01278394
Status:
COMPLETED
Last Update Posted:
2018-12-06
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed Description:
In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.
This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.
This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: