Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168064
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2005-09-07
Brief Title:
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Sponsor:
Yaupon Therapeutics
Organization:
Yaupon Therapeutics
Study Overview
Official Title:
A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard NM 002 Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides MF
Status:
COMPLETED
Status Verified Date:
2012-10
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:
This study will evaluate the efficacy tolerability and safety of the topical application of mechlorethamine MCH formulations in patients with stage I or IIA mycosis fungoides MF
Detailed Description:
The successful use of mechlorethamine MCH as a topical agent in the treatment of mycosis fungoides a form of cutaneous T-cell lymphoma was first reported in the late 1950s and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity Since then multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides This study will evaluate the efficacy non-inferiority tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF
Study Oversight
Has Oversight DMC:
None
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?:
None