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NCT02448381 · ClinicalTrials.gov registry record · Phase 3

FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

A Phase 3 study, sponsored by Soligenix.

Completed
Registry status
Phase 3
Development phase
169
Enrollment target

NCT02448381: Completed Phase 3 study, sponsored by Soligenix.

NCT02448381 is a Phase 3 study that has completed, run by Soligenix. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02448381, a Phase 3 study, has completed, sponsored by Soligenix.

COMPLETED
Registry status
Phase 3
Development phase
169 participants
Enrollment target

Study Summary

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Primary Outcome

The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (CAILS) 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

Interventions

  • DRUG Placebo
  • DRUG SGX301 (synthetic hypericin)

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2015-12
Est. Completion 2020-11
Phase Phase 3
Soligenix

10 total trials

What the finished NCT02448381 record still lists

NCT02448381 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02448381 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02448381 about?

NCT02448381 is a clinical study titled "FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)". To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

What is the current status of trial NCT02448381?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2015-12. Estimated completion is 2020-11.

What interventions are being tested in trial NCT02448381?

The interventions under investigation include: Placebo (DRUG), SGX301 (synthetic hypericin) (DRUG).

Who is sponsoring clinical trial NCT02448381?

This trial is sponsored by Soligenix, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02448381's enrollment target sits among peer trials

169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02448381, the US trial registry maintained by the National Library of Medicine. NCT02448381 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.