Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HyBryte (0.25% Hypericin)
HyBryte gel is applied twice weekly for 18 weeks.
  • Drug: Hypericin
    HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
    Other names:
    • HyBryte
    • SGX301
Placebo Comparator
Placebo
Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.
  • Drug: Placebo
    Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37212

More Details

Status
Recruiting
Sponsor
Soligenix

Study Contact

Jennifer Bonfrisco
609-538-8200
jbonfrisco@soligenix.com

Detailed Description

The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity (mCAILS) evaluation. Participants will be followed every 4 weeks for a total of 12 weeks following their last light session.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.