NCT06470451Phase 3Terminated

Confirmatory Study of Topical HyBryte™ vs. Placebo for 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 completion2026-05-22Actual

Enrollment · participants70Actual

Source updated2026-07-13Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-13 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~80 participants (planned)~~

+ After

70 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Jul 2026~~

+ After

22 May 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Terminated

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Study details

Conditions studied

CTCL/ Mycosis Fungoides; CTCL; Mycosis Fungoides; Cutaneous T Cell Lymphoma

Treatments or interventions studied

HypericinDrugAlso known as HyBryte, SGX301
PlaceboDrug

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 the cumulative mCAILS score of the index lesions at Week 18 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: 18 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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