Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305637
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
A Study Comparing Ketoconazole Shampoo 2 and Ketoconazole 2 Shampoo RS in the Treatment of Tinea Versicolor
Sponsor:
Taro Pharmaceuticals USA
Organization:
Taro Pharmaceuticals USA
Study Overview
Official Title:
A Multi-center Double-blind Randomized Placebo Controlled Parallel-group Study Comparing Ketoconazole Shampoo 2 to Ketoconazole Shampoo 2 RS and Both Active Treatments to a Placebo Control in the Treatment of Tinea Versicolor
Status:
COMPLETED
Status Verified Date:
2024-03
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:
To demonstrate the efficacy therapeutic equivalence and safety of Ketoconazole Shampoo 2 Taro Pharmaceuticals USA Inc and Ketoconazole 2 Shampoo Reference Standard in the treatment of tinea versicolor
Detailed Description:
A multi-center double-blind randomized placebo controlled parallel-group study comparing Ketoconazole Shampoo 2 Taro Pharmaceuticals USA Inc to Ketoconazole Shampoo 2 Reference Standard and both active treatments to a placebo control in the treatment of tinea versicolor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None