FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
1 other identifier
interventional
169
1 country
33
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2015
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedResults Posted
Study results publicly available
April 15, 2022
CompletedApril 15, 2022
March 1, 2022
4.5 years
May 13, 2015
February 14, 2022
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo
The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome. The overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.
8 weeks
Secondary Outcomes (4)
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo)
16 weeks
Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301
24 weeks
Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)
16 weeks
Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)
16 weeks
Study Arms (2)
SGX301
ACTIVE COMPARATORThree 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).
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Soligenixlead
Study Sites (33)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
University of Arizona
Phoenix, Arizona, 85004, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
University of Arkansas
Little Rock, Arkansas, 72205, United States
Stanford University
Palo Alto, California, 94304, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Olympian Clinical Research
Clearwater, Florida, 33756, United States
Leon Medical Research
Miami, Florida, 33015, United States
Medical Professional Clinical Research
Miami, Florida, 33165, United States
University of South Florida
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University
Chicago, Illinois, 60612, United States
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Rochester Skin Lymphoma Medical Group
Fairport, New York, 14450, United States
Columbia University Medical Center
New York, New York, 10032, United States
Stony Brook Medicine
Stony Brook, New York, 11790, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Jefferson Dermatology
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29424, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
MD Anderson
Houston, Texas, 77030, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
INOVA Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Virginia Clinical Research
Norfolk, Virginia, 23502, United States
Seattle Care Cancer Center
Seattle, Washington, 98109, United States
Related Publications (2)
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.
PMID: 35857290DERIVEDValipour 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.
PMID: 32632956DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Straube, MD/Chief Medical Officer
- Organization
- Soligenix, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 19, 2015
Study Start
December 1, 2015
Primary Completion
June 1, 2020
Study Completion
November 1, 2020
Last Updated
April 15, 2022
Results First Posted
April 15, 2022
Record last verified: 2022-03