Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-30 @ 1:50 AM
Study NCT ID:
NCT00890968
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2009-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis
Sponsor:
ZARS Pharma Inc.
Organization:
Study Overview
Official Title:
A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis
Status:
COMPLETED
Status Verified Date:
2012-03
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:
TAC-202
Brief Summary:
The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.
Detailed Description:
Triamcinolone acetonide is a commonly used, safe, and effective topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the effectiveness of topical agents such as creams or ointments is limited by patients' routine activities using bare hands that may remove the topical agent from the hands. The use of a topical corticosteroid in a vehicle that allows the product to remain in contact with the skin and is not susceptible to inadvertent removal would be beneficial.
The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time.
This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.
The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time.
This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.
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?: