Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05872854
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-04-07
Brief Title:
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
Sponsor:
Ellen Kim MD
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
Status:
RECRUITING
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:
RW-HPN-MF-01
Brief Summary:
The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment HyBryte and visible light in patients with mycosis fungoides for up to 12 months 54 weeks Funding Source FDA OOPD
Detailed Description:
This is an open label trial in which patients will have their mycosis fungoides MF lesions treated twice a week with HyBryte ointment that is followed 24 hours later 6 hours by activation of the drug with visible light treatment Patients will treat all of their MF lesions where accessible to light therapy but 3 to 5 lesions will be identified and followed as Index Lesions that will be evaluated using the Composite Assessment of Index Lesion Severity CAILS score every 6 weeks for the up to 54 weeks of therapy Patients will be treated until resolution dropout for adverse events or plateau of therapeutic response occurs Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RW-HPN-MF-01 | OTHER | None | None |
| 851617 | OTHER | IRB number | None |