Cutaneous T-Cell Lymphoma/Mycosis FungoidesPhase 2NCT06149247
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
A Phase 2 study testing Hypericin and Mechlorethamine Topical Gel in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by Soligenix at 1 site in United States.
Trial summary
The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment. 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 Mechlorethamine Topical Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 27 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Minimum of 3 active treatment-accessible CTCL lesions
- Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA
- 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 30 days prior to treatment initiation
Who cannot join
- History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
- Pregnancy or mothers who are breast-feeding
- All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
- Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
- Subjects whose condition is spontaneously improving
- Subjects receiving Valchlor (or any topical compound containing Mechlorethamine) in the preceding 2 months
Show all 13Show fewer
- Subjects receiving topical steroids or other topical treatments (eg, targretin gel) on treatment accessible lesions for CTCL within 2 weeks of enrollment
- Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (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 has any condition that, in the judgment of the Investigator, is likely to interfere with participation in the study
- Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte 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
Rochester Skin Lymphoma Medical Group
Fairport, New York, 14450
About this study
Official title: Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.
Read the detailed description
Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial.
Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.
- Being tested
- Hypericin, Mechlorethamine Topical Gel
- Keywords
- CTCL, MF, Hypericin, HyBryte
- Medical subject headings
- 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.
Mechlorethamine Topical GelDrug
Also called Valchlor
Valchlor is an FDA-approved drug for the treatment of CTCL.
| Study group | Role | What they receive |
|---|---|---|
| HyBryte (0.25 % hypericin) | Experimental | HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 6 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks. Receives: Drug: Hypericin |
| Valchlor (mechlorethamine) | Active comparator | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. Receives: Drug: Mechlorethamine Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score
A treatment response is defined as a ≥50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline.
The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start5 Dec 2023
- Primary completion31 May 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous T-Cell Lymphoma/Mycosis FungoidesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soligenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149247
- Sponsor's protocol ID
- HPN-CTCL-04
- Status last verified
- Aug 2025
- First submitted
- 20 Nov 2023
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Poligone B, Pullion C, Rumage A, Straube R, Donini O, Schaber CJ, Gilmore ES. Results from a Pilot Study of HyBryte (Topical Synthetic Hypericin) Versus Valchlor(R) (Mechlorethamine) in the Treatment of CTCL. Oncol Ther. 2026 Jun;14(2):693-705. doi: 10.1007/s40487-026-00430-1. Epub 2026 Apr 1.
PubMed 41920467
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
- ClinicalTrials.gov ID
- NCT06149247
- Acronym / sponsor ID
- HPN-CTCL-04
- Keywords
- CTCL, MF, Hypericin, HyBryte
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SoligenixIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.
Detailed description
Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial.
Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HyBryte (0.25 % hypericin) | Experimental | Drug: HypericinHyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 6 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 12 weeks. |
| Valchlor (mechlorethamine) | Active comparator | Drug: Mechlorethamine Topical GelValchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 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)
- Minimum of 3 active treatment-accessible CTCL lesions
- Subjects must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IA, IB, or Stage IIA
- 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 30 days prior to treatment initiation
Key exclusion criteria (13 listed)
- History of severe allergic reaction to any of the components of HyBryte or mechlorethamine (Valchlor)
- Pregnancy or mothers who are breast-feeding
- All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception
- Subjects with history of sun hypersensitivity or photosensitive dermatoses (eg, porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, 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) |
| Mechlorethamine Topical GelAlso: ValchlorValchlor is an FDA-approved drug for the treatment of CTCL. | Drug | Valchlor (mechlorethamine) |
Primary outcome
Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score
Time frame: 12 weeks
A treatment response is defined as a ≥50% improvement in mCAILS score at Week 12 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41920467Poligone B, Pullion C, Rumage A, Straube R, Donini O, Schaber CJ, Gilmore ES. Results from a Pilot Study of HyBryte (Topical Synthetic Hypericin) Versus Valchlor(R) (Mechlorethamine) in the Treatment of CTCL. Oncol Ther. 2026 Jun;14(2):693-705. doi: 10.1007/s40487-026-00430-1. Epub 2026 Apr 1.
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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 Mechlorethamine Topical Gel in people with Cutaneous T-Cell Lymphoma/Mycosis Fungoides, run by Soligenix 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 13 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 20 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149247, which also lists 1 linked publication.
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 20 Aug 2025.