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

(FLASH2)

Sponsored by Soligenix

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Nov 14, 2025

Phase

Clinical Trial

Sponsor

Soligenix

Enrollment Target

80

Start Date

Jan 2025

📊
1 of 80 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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

Who Can Participate

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 con

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

📋

Study Type

INTERVENTIONAL

👥

Target Enrollment

80 participants

Gender

ALL

🏢

Sponsor

Soligenix

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Phoenix

Arizona

Location available
RECRUITING

Scottsdale

Arizona

Location available
RECRUITING

San Diego

California

Location available
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Chicago

Illinois

Location available
RECRUITING

Indianapolis

Indiana

Location available
RECRUITING

St Louis

Missouri

Location available
RECRUITING

Fairport

New York

Location available
COMPLETED

New York

New York

Location available

📍 And 8 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Cutaneous T Cell Lymphoma Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Cutaneous T Cell Lymphoma Treatment Options in Phoenix, Arizona

If you're searching for Cutaneous T Cell Lymphoma treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Scottsdale, San Diego and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Cutaneous T Cell Lymphoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 80 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Cutaneous T Cell Lymphoma?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Cutaneous T Cell Lymphoma

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Cutaneous T Cell Lymphoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06470451. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.