FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

NCT ID: NCT02448381

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-11-30

Brief Summary

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Conditions

Cutaneous T-Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SGX301

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy.

Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated.

Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment.

Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

Group Type: ACTIVE_COMPARATOR

SGX301 (synthetic hypericin)

Intervention Type: DRUG

0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Placebo

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Interventions

SGX301 (synthetic hypericin)

0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Intervention Type: DRUG

Placebo

USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Intervention Type: DRUG

Other Intervention Names

Hypericin; Synthetic Hypericin

Eligibility Criteria

Inclusion Criteria

• Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
• Subjects must have a minimum of three (3) evaluable, discrete lesions.
• Subjects must be willing to refrain from sunbathing for the duration of the study.

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.
• Pregnancy or mothers who are breast feeding.
• Males and females not willing to use effective contraception.
• Unhealed sunburn.
• Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.
• Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
• Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.
• Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soligenix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

University of Arizona

Phoenix, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

University of Arkansas

Little Rock, Arkansas, United States

Stanford University

Palo Alto, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Olympian Clinical Research

Clearwater, Florida, United States

Leon Medical Research

Miami, Florida, United States

Medical Professional Clinical Research

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Rush University

Chicago, Illinois, United States

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, United States

Tulane University

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Rochester Skin Lymphoma Medical Group

Fairport, New York, United States

Columbia University Medical Center

New York, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

PMG Research of Wilmington

Wilmington, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Jefferson Dermatology

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson

Houston, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

INOVA Schar Cancer Institute

Fairfax, Virginia, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Seattle Care Cancer Center

Seattle, Washington, United States

Countries

United States

References

Kim EJ, Mangold AR, DeSimone JA, Wong HK, Seminario-Vidal L, Guitart J, Appel J, Geskin L, Lain E, Korman NJ, Zeitouni N, Nikbakht N, Dawes K, Akilov O, Carter J, Shinohara M, Kuzel TM, Piette W, Bhatia N, Musiek A, Pariser D, Kim YH, Elston D, Boh E, Duvic M, Huen A, Pacheco T, Zwerner JP, Lee ST, Girardi M, Querfeld C, Bohjanen K, Olsen E, Wood GS, Rumage A, Donini O, Haulenbeek A, Schaber CJ, Straube R, Pullion C, Rook AH, Poligone B. Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Sep 1;158(9):1031-1039. doi: 10.1001/jamadermatol.2022.2749.

Reference Type: DERIVED

PMID: 35857290 (View on PubMed)

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Reference Type: DERIVED

PMID: 32632956 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.rarediseases.org/

The National Organization for Rare Disorders

http://www.clfoundation.org/

The Cutaneous Lymphoma Foundation

Other Identifiers

HPN-CTCL-01

Identifier Type: -

Identifier Source: org_study_id