Clinical TrialID 8250
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
NCT06149247
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8250
- Evidence Id
- 8250
- Core Evidence Id
- 8250
- Source Clinical Trial Id
- 8248
- Herb2 Clinical Trial Id
- HBCT008248
- Nct Id
- NCT06149247
- Title
- HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
- Status
- Completed
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Hypericin|DRUG: Mechlorethamine Topical Gel
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 10
- Outcome Measure
- Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score, A treatment response is defined as a ≥50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome., 12 weeks
- Sponsor Collaborator
- Soligenix
- Funded By
- INDUSTRY
- Location
- Rochester Skin Lymphoma Medical Group, Fairport, New York, 14450, United States
- Other Id
- HPN-CTCL-04
- Start Date
- 2023-12-05
- Primary Completion Date
- 2024-05-31
- Completion Date
- 2024-06-27
- First Posted
- 2023-11-28
- Results First Posted
- Last Update Posted
- 2024-07-03
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT06149247
- Title Cn
- Title En
- HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
- Bilingual Status
- semi_complete