Clinical trial · Interventional
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility
Summary
Brief summary (as posted)
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CTCL | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| CTCL/ Mycosis Fungoides | Mycosis Fungoides | ALIAS | 0.90 |
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypericin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HyBryte (0.25% Hypericin)
- description
- HyBryte gel is applied twice weekly for 18 weeks.
- interventionNames
- Drug: Hypericin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available