Cutaneous T Cell LymphomaPhase 2RW-HPN-MF-01NCT05872854
Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
A Phase 2 study testing Hypericin and Visible Light in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by Ellen Kim, MD at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- What is being tested?
- Hypericin and Visible Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 22 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19034
About this study
The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.
Read the detailed description
This is an open label trial in which patients will have their mycosis fungoides (MF) lesions treated twice a week with HyBryte ointment that is followed, 24 hours later (±6 hours), by activation of the drug with visible light treatment. Patients will treat all of their MF lesions (where accessible to light therapy), but 3 to 5 lesions will be identified and followed as "Index Lesions" that will be evaluated using the Composite Assessment of Index Lesion Severity (CAILS) score every 6 weeks for the up to 54 weeks of therapy. Patients will be treated until resolution, dropout for adverse events, or plateau of therapeutic response occurs. Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment.
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Being tested
- Hypericin, Visible Light
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypericinDrug
Also called HyBryte, SGX301
HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment
Visible LightOther
Also called Fluorescent light
After application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte.
| Study group | Role | What they receive |
|---|---|---|
| HyBryte (0.25 % Hypericin) with Visible Light | Experimental | 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. Receives: Drug: Hypericin; Other: Visible Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Responses of Index Lesions
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.
Measured: Baseline up to 54 weeks
Secondary outcomes (13)
The percent of patients achieving a Complete Response of All Lesions
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.
Measured: Baseline up to 54 weeks
The percent of patients achieving a PGA score of 3 (moderate improvement) from baseline to end of treatment.
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:
- 0 completely clear = No evidence of disease; 100% improvement
- 1 almost clear = Very obvious improvement (≥90% to <100%); only traces of disease remain
- 2 marked improvement = Significant improvement (≥50 to <90% clear); some evidence of disease remains
- 3 moderate improvement = Intermediate between marked and mild (≥25% to <50%)
- 4 slight improvement = ≥10% to <25%; significant evidence of disease remains
- 5 no change = Disease has not changed significantly from baseline (10 to -25%)
- 6 condition worse = Disease is worse than baseline by ≥25%
Measured: 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.
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.
Measured: Baseline up to 54 weeks
The percent of patients achieving at least 50% change in VASitch from baseline to end of treatment.
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)
Measured: Baseline up to 54 weeks
The change in CAILS score for each Index Lesion from baseline to end of treatment.
The CAILS score was previously described.
Measured: 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.
The CAILS score was previously described.
Measured: Baseline up to 54 weeks.
The relative change in CAILS score for lesions classified as patch compared to plaque from baseline to end of treatment.
The CAILS score was previously described.
Measured: Baseline up to 54 weeks
The time to maximal response in cumulative CAILS score.
These scores were previously described.
Measured: Baseline up to 54 weeks
The time to maximal response in cumulative PGA score.
This score was previously described.
Measured: Baseline up to 54 weeks
The time to maximal response in cumulative mSWAT score.
This score was previously described.
Measured: Baseline up to 54 weeks
The time to maximal response in cumulative VASitch score.
This score was previously described.
Measured: Baseline up to 54 weeks
Change in Skindex-29 score at Week 12, Week 24, Week 36 and Week 54
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.
Measured: Baseline up to 54 weeks
Change in Patient Benefit Index score at Week 12, Week 24, Week 36 and Week 54
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.
Measured: Baseline up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start21 Aug 2023
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The goal of this clinical trial is to assess the benefit of continuous treatment with open label synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Kim, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Soligenix
- Responsible party
- Sponsor-investigator, Ellen Kim, MD, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872854
- Sponsor's protocol ID
- 05622 (UPCC)
- Other IDs
- RW-HPN-MF-01, 851617
- Acronym
- RW-HPN-MF-01
- Status last verified
- Feb 2026
- First submitted
- 7 Apr 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light
- ClinicalTrials.gov ID
- NCT05872854
- Acronym / sponsor ID
- RW-HPN-MF-01 / 05622 (UPCC)
- Conditions
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Keywords
- Cutaneous T Cell Lymphoma, Mycosis Fungoides
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ellen Kim, MDUniversity, hospital or other
- Collaborators
- Soligenix
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the benefit of continuous treatment with synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks). Funding Source: FDA OOPD.
Detailed description
This is an open label trial in which patients will have their mycosis fungoides (MF) lesions treated twice a week with HyBryte ointment that is followed, 24 hours later (±6 hours), by activation of the drug with visible light treatment. Patients will treat all of their MF lesions (where accessible to light therapy), but 3 to 5 lesions will be identified and followed as "Index Lesions" that will be evaluated using the Composite Assessment of Index Lesion Severity (CAILS) score every 6 weeks for the up to 54 weeks of therapy. Patients will be treated until resolution, dropout for adverse events, or plateau of therapeutic response occurs. Changes in the skin scoring mechanisms such as the CAILs and mSWAT will be tabulated for each patient and assessed across all patients enrolled in the trial to determine the response profile of HyBryte and visible light treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The goal of this clinical trial is to assess the benefit of continuous treatment with open label synthetic hypericin ointment (HyBryte) and visible light in patients with mycosis fungoides for up to 12 months (54 weeks).
| Arm | Type | Receives |
|---|---|---|
| HyBryte (0.25 % Hypericin) with Visible Light | Experimental | Drug: Hypericin, Other: Visible LightHyBryte (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypericinAlso: HyBryte, SGX301HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment | Drug | HyBryte (0.25 % Hypericin) with Visible Light |
| Visible LightAlso: Fluorescent lightAfter application of HyBryte (0.25% hypericin ointment), participants will be placed in a light booth containing fluorescent light bulbs to activate the HyBryte. | Other | HyBryte (0.25 % Hypericin) with Visible Light |
Primary outcome
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.
13 secondary outcomes
The percent of patients achieving a Complete Response of All Lesions
Time frame: 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 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
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 change in CAILS score for each Index Lesion from baseline to end of treatment.
Time frame: 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 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 time to maximal response in cumulative CAILS score.
Time frame: Baseline up to 54 weeks
The time to maximal response in cumulative PGA score.
Time frame: Baseline up to 54 weeks
The time to maximal response in cumulative mSWAT score.
Time frame: Baseline up to 54 weeks
The time to maximal response in cumulative VASitch score.
Time frame: 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
Change in Patient Benefit Index score at Week 12, Week 24, Week 36 and Week 54
Time frame: Baseline up to 54 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Related trials for Cutaneous T Cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
Extracorporeal Photopheresis in Sezary Syndrome
Sezary Syndrome
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypericin and Visible Light in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by Ellen Kim, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Responses of Index Lesions (time frame: Baseline up to 54 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.