Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06149247
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-11-20
Brief Title:
HyBryte Synthetic Hypericin Versus Valchlor Mechlorethamine in the Treatment of CTCL
Sponsor:
Soligenix
Organization:
Soligenix
Study Overview
Official Title:
Pilot Study of HyBryte Synthetic Hypericin Versus Valchlor Mechlorethamine in the Treatment of CTCL
Status:
COMPLETED
Status Verified Date:
2024-07
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 objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment
Detailed Description:
Participants will be randomized to receive HyBryte or Valchlor in a 11 randomization Participants will be treated for 12 weeks and follow-up visits will be conducted 1 2 and 4 weeks after completion of the treatment phase of the trial
Prior to randomization each participant will have at least 3 and up to 5 lesions identified index lesions that will be evaluated during the treatment phase and during the follow-up visits
Prior to randomization each participant will have at least 3 and up to 5 lesions identified index lesions that will be evaluated during the treatment phase and during the follow-up visits
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?:
None
Is an FDA AA801 Violation?:
None