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Light-Activated gel shows promise for rare skin cancer

NCT ID NCT06470451

Disease control Sponsor: Soligenix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a gel called HyBryte, which is activated by visible light, for treating cutaneous T-cell lymphoma (CTCL), a rare type of skin cancer. About 80 adults with early-stage CTCL will apply the gel or a placebo twice a week for 18 weeks, then receive light treatment. The goal is to see if the gel can significantly reduce the size and severity of skin lesions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HyBryte (hypericin sodium) gel plus visible light activation
What this could lead to
If successful, this could provide a new topical treatment option for early-stage cutaneous T-cell lymphoma, potentially reducing skin lesions without systemic side effects.
What could go wrong
This is a relatively small Phase 3 trial (80 participants), and the treatment may not work better than placebo. Skin sensitivity and local reactions are possible risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

70 people

The number who actually took part.

Started

Jan 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA. * Patients with a minimum of three (3) evaluable, discrete lesions. * Patients willing to follow the clinical protocol and voluntarily give their written informed consent. * Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation. Exclusion Criteria: * History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling. * History of allergy or hypersensitivity to any of the components of HyBryte. * A Screening ECG with a QT interval \>470 ms (corrected for heart rate using the Fridericia's formula). * All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception. * Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment. * Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment. * Patients who have received electron beam irradiation within 3 months of enrollment. * Patients with a history of significant systemic immunosuppression. * Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study. * Patients whose condition is spontaneously improving. * Patients with tumor stage or erythrodermic CTCL (stages IIB-IV). * Patients with extensive skin disease (\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment. * Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study. * Prior participation in the current study.

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Conditions

The condition(s) this trial relates to.

mycosis fungoides primary cutaneous T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CTCL CTCL/ mycosis fungoides Cutaneous T-cell lymphoma Mycosis fungoides

Contacts and locations

Locations

  • Accellacare (PMG)

    Wilmington, North Carolina, 28411, United States

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dawes Fretzin Dermatology Group

    Indianapolis, Indiana, 46256, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Penn State Health Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Rochester Skin Lymphoma Medical Group

    Fairport, New York, 14450, United States

  • Therapeutics Clinical Research

    San Diego, California, 92123, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Vanderbilt University

    Nashville, Tennessee, 37212, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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