Clinical TrialID 2580
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
NCT02448381
Cutaneous T-Cell Lymphoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2580
- Evidence Id
- 2580
- Core Evidence Id
- 2580
- Source Clinical Trial Id
- 2559
- Herb2 Clinical Trial Id
- HBCT002559
- Nct Id
- NCT02448381
- Title
- FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Cutaneous T-Cell Lymphoma
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: SGX301 (synthetic hypericin)|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 169
- Outcome Measure
- 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
- Sponsor Collaborator
- Soligenix
- Funded By
- INDUSTRY
- Location
- 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, Saint 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
- Other Id
- HPN-CTCL-01
- Start Date
- 2015-12
- Primary Completion Date
- 2020-06
- Completion Date
- 2020-11
- First Posted
- 2015-05-19
- Results First Posted
- 2022-04-15
- Last Update Posted
- 2022-04-15
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/81/NCT02448381/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/81/NCT02448381/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02448381
- Title Cn
- Title En
- FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
- Bilingual Status
- semi_complete