- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05872854
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light (RW-HPN-MF-01)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Cynthia A Clark, PhD, CRNP
- Phone Number: 215-687-6652
- Email: cynthia.clark2@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19034
- Recruiting
- Perelman Center for Advanced Medicine
-
Contact:
- Paola Santos, MD
- Phone Number: 267-515-2967
- Email: paola.santos@pennmedicine.upenn.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage 1A, Stage 1B, or Stage 2A.
(Stage 1 is divided into stages 1A and 1B as follows: Stage 1A: Patches, papules, and/or plaques cover less than 10% of the skin surface. Stage 1B: Patches, papules, and/or plaques cover 10% or more of the skin surface. Stage 2A: Patches, papules, and/or plaques cover any amount of skin surface. Lymph nodes are abnormal, but they are not cancerous.)
- Subjects willing to follow the clinical protocol and voluntarily give their written informed consent
- Female subjects not pregnant nor nursing and willing to undergo a pregnancy test within 21 days prior to treatment initiation and agree to use a medically accepted method of birth control such as oral contraceptives (birth control pill), Barrier method (condom plus spermicide or diaphragm plus spermicide) or abstaining from intercourse while on study
Exclusion Criteria:
- History of allergy or hypersensitivity to any of the components of SGX301
- Pregnancy or mothers who are breast-feeding
- Males and females not willing to use effective contraception
- Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus, Sjogren's, etc.).
- Subjects whose condition is spontaneously improving.
- Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on lesions for CTCL within 2 weeks of enrollment
- Subjects receiving systemic steroids, 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 who have received electron beam irradiation within 3 months of enrollment
- Subjects with a history of significant systemic immunosuppression
- Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
- Subject with any condition that, in the judgment of the PI, is likely to interfere with participation in the study
- Subjects receiving drugs known to cause photosensitization within 2 weeks of starting SGX301 therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HyBryte (0.25 % Hypericin) with Visible Light
HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 24 (±6) hours later starting at 5 J/cm^2.
Drug application/light sessions will be done twice a week (at least 2 calendar days apart) for up to 54 weeks.
|
HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment
Other Names:
After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Treatment Responses of Index Lesions
Time Frame: Baseline up to 54 weeks
|
A Treatment Response is defined as a ≥50% improvement in the Composite Assessment of Index Lesion Severity (CAILS) score score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the CAILS score at baseline. The 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 is calculated by adding the total score as described above for each of the 3-5 index lesions. A lower score means a better outcome. |
Baseline up to 54 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percent of patients achieving a Complete Response of All Lesions
Time Frame: Baseline up to 54 weeks
|
A Complete Response is defined as a Modified Severity Weighted Assessment Tool (mSWAT) score of 0 for all lesions at each evaluation timepoint (every 6 weeks up to 54 weeks).
The mSWAT is based on an estimate of the percent total area of skin with lesions based on the body surface area (BSA), and the types of lesions present (patch, plaque, or tumor).
A lower score means a better outcome.
|
Baseline up to 54 weeks
|
The percent of patients achieving a PGA score of 3 (moderate improvement) from baseline to end of treatment.
Time Frame: Baseline up to 54 weeks
|
The Physician Global Assessment (PGA) represents the investigator's assessment of the overall extent of improvement or worsening of the patient's cutaneous disease compared with baseline at each evaluation timepoint (every 6 weeks up to 54 weeks). This assessment is designed to consider all cutaneous lesions, including both index and non-index lesions, using a scale of 0 to 6, as described below:
|
Baseline up to 54 weeks
|
The percent of patients achieving at least 50% change in the mSWAT (overall skin score) from baseline to end of treatment.
Time Frame: Baseline up to 54 weeks
|
A ≥50% improvement of the Modified Severity Weighted Assessment Tool (mSWAT) score at each evaluation timepoint (every 6 weeks up to 54 weeks) when compared to the mSWAT score at baseline.
The mSWAT score was previously described.
|
Baseline up to 54 weeks
|
The percent of patients achieving at least 50% change in VASitch from baseline to end of treatment.
Time Frame: Baseline up to 54 weeks
|
The Visual Analog Scale for itch (VASitch) is a self-evaluation of the amount of itch that the patient has experienced on a visual scale of 0 to 10.
A lower score means less itch is experienced.
Patients will be asked to to assess the amount of itch they had experienced in the previous 24 hours at every light treatment visit (2 visits per week up to 54 weeks)
|
Baseline up to 54 weeks
|
The change in CAILS score for each Index Lesion from baseline to end of treatment.
Time Frame: Baseline up to 54 weeks.
|
The CAILS score was previously described.
|
Baseline up to 54 weeks.
|
The time needed to achieve at least a 50% change in the cumulative CAILS score of Index Lesions from baseline.
Time Frame: Baseline up to 54 weeks.
|
The CAILS score was previously described.
|
Baseline up to 54 weeks.
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The relative change in CAILS score for lesions classified as patch compared to plaque from baseline to end of treatment.
Time Frame: Baseline up to 54 weeks
|
The CAILS score was previously described.
|
Baseline up to 54 weeks
|
The time to maximal response in cumulative CAILS score.
Time Frame: Baseline up to 54 weeks
|
These scores were previously described.
|
Baseline up to 54 weeks
|
The time to maximal response in cumulative PGA score.
Time Frame: Baseline up to 54 weeks
|
This score was previously described.
|
Baseline up to 54 weeks
|
The time to maximal response in cumulative mSWAT score.
Time Frame: Baseline up to 54 weeks
|
This score was previously described.
|
Baseline up to 54 weeks
|
The time to maximal response in cumulative VASitch score.
Time Frame: Baseline up to 54 weeks
|
This score was previously described.
|
Baseline up to 54 weeks
|
Change in Skindex-29 score at Week 12, Week 24, Week 36 and Week 54
Time Frame: Baseline up to 54 weeks
|
The Skindex-29 is a self-administered survey to measure the effects of skin disease on patients' quality of life.
Skindex-29 inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item.
Seven items address the Symptoms domain, ten items the Emotional domain, and twelve items the Functioning domain.
All responses are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time).
Skindex scores are reported as three scale scores, corresponding to the three domains; a scale score is the average of a patient's responses to items in a given domain.
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Baseline up to 54 weeks
|
Change in Patient Benefit Index score at Week 12, Week 24, Week 36 and Week 54
Time Frame: Baseline up to 54 weeks
|
The Patient Benefit Index (PBI) is a self-administered assessment of the patient-reported benefit in the treatment of their skin disease and is calculated based on the Patient Needs Questionnaire (PNQ) at baseline and Patient Needs Questionnaire (PNQ) at treatment time point.
Patients with PBI ≥ 1 are considered having at least minimum patient-relevant treatment benefit.
|
Baseline up to 54 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma
- Mycoses
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Psychotropic Drugs
- Antidepressive Agents
- Hypericin
Other Study ID Numbers
- 05622 (UPCC)
- RW-HPN-MF-01 (Other Identifier: Other Identifier)
- 851617 (Other Identifier: IRB number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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