NCT06149247Phase 2Completed

HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

Study sponsor: Soligenix

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-05-31Actual

Enrollment · participants10Actual

Source updated2025-08-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Treatments or interventions studied

HypericinDrugAlso known as HyBryte, SGX301
Mechlorethamine Topical GelDrugAlso known as Valchlor

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score; description: 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.; timeFrame: 12 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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