Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-17
Brief Title:
Confirmatory Study of Topical HyBryte vs Placebo for the Treatment of CTCL
Sponsor:
Soligenix
Organization:
Soligenix
Study Overview
Official Title:
A Confirmatory Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study of the Efficacy of Topical HyBryte Hypericin Sodium and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma CTCL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
FLASH2
Brief Summary:
To evaluate the use of HyBryte a topical photosensitizing agent to treat patients with patchplaque phase cutaneous T-cell lymphoma mycosis fungoides
Detailed Description:
The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patchplaque phase CTCL compared to patients receiving placebo and visible lightThe study will evaluate the efficacy and safety of HyBryte 025 hypericin gel or placebo gel applied twice weekly for 18 weeks Treated lesions will be covered with opaque material such as opaque clothing followed 21 3 hours later by the administration of visible light All of the participants lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity mCAILS evaluation Participants will be followed every 4 weeks for a total of 12 weeks following their last light session
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