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

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ClinicalTrials.gov Identifier: NCT02448381
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Soligenix

May 13, 2015
May 19, 2015
August 28, 2018
December 2015
December 2018   (Final data collection date for primary outcome measure)
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 [ Time Frame: 8 weeks ]
To evaluate the ability of a 6-week course of SGX301 and visible light in patients with patch/plaque phase cutaneous T-cell lymphoma (CTCL, mycosis fungoides) to induce a treatment response in 3 lesions when compared to patients receiving placebo and visible light.
Treatment Response in 3 treated lesions as as defined to be a ≥50% improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) score when compared to patients receiving placebo [ Time Frame: 8 weeks ]
To evaluate the ability of a 6-week course of SGX301 and visible light in patients with patch/plaque phase cutaneous T-cell lymphoma (CTCL, mycosis fungoides) to induce a treatment response in 3 lesions when compared to patients receiving placebo and visible light.
Complete list of historical versions of study NCT02448381 on ClinicalTrials.gov Archive Site
  • Complete Response in 3 treated lesions as defined to be a Composite Assessment of Index Lesion Disease Severity (CAILS) score of 0 [ Time Frame: 8 weeks ]
    To evaluate the ability of topical SGX301 and visible light in patients with patch/plaque phase CTCL to induce biopsy-proven Complete Response.
  • Degree of Improvement of 3 treated lesions as measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) score [ Time Frame: 16 weeks ]
    To evaluate the degree of improvement of the lesions induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL.
  • Duration of Response as measured monthly for 6 months by the appearance of new lesions after the treatment period has ended [ Time Frame: 24 weeks ]
    To evaluate the duration of Partial and/or Complete Response in the lesions induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL.
  • Time to Relapse as measured by any disease recurrence in participants with a Complete Response [ Time Frame: 24 weeks ]
    To evaluate the time to lesion relapse induced by topical SGX301 and visible light in patients with patch/plaque phase CTCL.
  • Safety as assessed by the number of participants with Adverse Events [ Time Frame: 24 weeks ]
    To assess the safety of topical SGX301 and visible light in patients with patch/plaque phase CTCL.
Same as current
Not Provided
Not Provided
 
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
To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cutaneous T-Cell Lymphoma
  • Drug: 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.
    Other Names:
    • Hypericin
    • Synthetic Hypericin
  • 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.
  • Active Comparator: 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).

    Intervention: Drug: SGX301 (synthetic hypericin)
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
135
Not Provided
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Christopher Pullion, DO 609-538-8200 ext 23 cpullion@soligenix.com
Contact: Richard Straube, MD 609-538-8200 ext 30 rstraube@soligenix.com
United States
 
 
NCT02448381
HPN-CTCL-01
Not Provided
Not Provided
Not Provided
Soligenix
Soligenix
Not Provided
Not Provided
Soligenix
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP