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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Soligenix
Study ID
NCT06470451
Phase
PHASE3
Status
Recruiting
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Conditions

  • CTCL
  • CTCL/ Mycosis Fungoides
  • Cutaneous T Cell Lymphoma
  • Mycosis Fungoides

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypericin — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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

Key Dates

Start date
Jan 7, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HyBryte (0.25% Hypericin)
    HyBryte gel is applied twice weekly for 18 weeks.
  • Placebo Comparator: Placebo
    Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.

Primary Outcome Measure

Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score [ Time Frame: 18 weeks ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Medical Dermatology SpecialistsPhoenixArizona85006-
Mayo ClinicScottsdaleArizona85259
Clinical Trials Referral Office
855-776-0015
Aaron Mangold, MD (PRINCIPAL_INVESTIGATOR)
Therapeutics Clinical ResearchSan DiegoCalifornia92123-
University of South FloridaTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611
Deptarment of Dermatology Research
[email protected]
Dawes Fretzin Dermatology GroupIndianapolisIndiana46256
Lana Johnson
[email protected]
317-516-5030
Kenneth Dawes, MD
[email protected]
317-516-5030
Kenneth Dawes, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Jian Yang
[email protected]
314-273-3737
Amy Musiek, MD
[email protected]
314-362-8171
Amy Musiek, MD (PRINCIPAL_INVESTIGATOR)
Rochester Skin Lymphoma Medical GroupFairportNew York14450
Lily Hauschildt
[email protected]
585 364-1188
Brian Poligone, MD, PhD
[email protected]
585-364-2075
Brian Poligone, MD, PhD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032-
Accellacare (PMG)WilmingtonNorth Carolina28411-
Penn State Health Hershey Medical CenterHersheyPennsylvania17033
Dermatology Clinical Trials Office
[email protected]
717-531-5136
Christopher Bazewicz, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Laura Cesar
[email protected]
445-800-6538
Ellen Kim, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
David Liotta
[email protected]
412-864-3681
Oleg Akilov, MD, PhD
[email protected]
412 864-3717
Oleg Akilov, MD, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37212-
MD AndersonHoustonTexas77030
Alda Ashu
[email protected]
713-792-1280
Auris Huen, MD
[email protected]
Auris Huen, MD (PRINCIPAL_INVESTIGATOR)
Austin Institute for Clinical ResearchPflugervilleTexas78660
Tommy Ha
[email protected]
512-279-2545
Edward Lain, MD (PRINCIPAL_INVESTIGATOR)
Inova Schar Cancer InstituteFairfaxVirginia22031
Kelly Jeffords
[email protected]
703-970-6548
Jennifer DeSimone, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Medical Dermatology Specialists· Phoenix, AZMayo Clinic· Scottsdale, AZTherapeutics Clinical Research· San Diego, CAUniversity of South Florida· Tampa, FLNorthwestern University· Chicago, ILDawes Fretzin Dermatology Group· Indianapolis, IN

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