OncoMatch

OncoMatch/Clinical Trials/NCT06470451

Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Is NCT06470451 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Hypericin for ctcl/ mycosis fungoides.

Phase 3RecruitingSoligenixNCT06470451Data as of Jun 2026

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

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Extracted eligibility criteria

Treatments studied

Other

Hypericin

Cancer type

Non-Hodgkin Lymphoma

Disease stage

Required: Stage IA, IB, IIA

Excluded: Stage IIB, III, IV

Prior therapy

Cannot have received: topical steroid

Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment

Cannot have received: topical therapy (nitrogen mustard)

Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment

Cannot have received: systemic steroid

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

Cannot have received: psoralen UVA radiation therapy

psoralen UVA radiation therapy (PUVA)

Cannot have received: narrow band UVB light therapy

narrow band UVB light therapy (NB-UVB)

Cannot have received: systemic therapy (carmustine)

carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment

Cannot have received: electron beam irradiation

Patients who have received electron beam irradiation within 3 months of enrollment

Lab requirements

Cardiac function

Screening ECG with QT interval >470 ms (corrected for heart rate using the Fridericia's formula) excluded

A Screening ECG with a QT interval >470 ms (corrected for heart rate using the Fridericia's formula)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Medical Dermatology Specialists · Phoenix, Arizona
  • Mayo Clinic · Scottsdale, Arizona
  • Therapeutics Clinical Research · San Diego, California
  • University of South Florida · Tampa, Florida
  • Northwestern University · Chicago, Illinois

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06470451 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior topical steroid, topical therapy, systemic steroid disqualifies patients from enrollment.

What disease stage is eligible?

Stage IA or IB or IIA is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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