Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01278394
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.
Study:
NCT01278394
Study Brief:
Protocol Section:
NCT01278394