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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 : Active, not recruiting
First Posted : May 19, 2015
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Soligenix

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE May 19, 2015
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous T-Cell Lymphoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 3, 2019)
169
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)
135
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02448381
Other Study ID Numbers  ICMJE HPN-CTCL-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soligenix
Study Sponsor  ICMJE Soligenix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Soligenix
Verification Date December 2019

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