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The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Valchlor (mechlorethamine) | Active Comparator | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypericin | Drug | HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Skin Lymphoma Medical Group | Fairport | New York | 14450 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41920467 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HyBryte (0.25 % Hypericin) | 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. |
| FG001 | Valchlor (Mechlorethamine) | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HyBryte (0.25 % Hypericin) | 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. |
| BG001 | Valchlor (Mechlorethamine) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
From enrollment until end of follow-up, up to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HyBryte (0.25 % Hypericin) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swollen lymph nodes | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Straube, MD/Chief Medical Officer | Soligenix, Inc. | 609-538-8200 | rstraube@soligenix.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2024 | Aug 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C004965 | hypericin |
| D000588 | Amines |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
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| Mechlorethamine Topical Gel | Drug | Valchlor is an FDA-approved drug for the treatment of CTCL. |
|
|
Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Valchlor (Mechlorethamine) | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Valchlor (Mechlorethamine) | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. | 0 | 5 | 0 | 5 | 3 | 5 |
| Allergic contact dermatitis | General disorders | Systematic Assessment |
|
| Dermatitis | General disorders | Systematic Assessment |
|
| Rash | General disorders | Systematic Assessment |
|
| Sensitivity | General disorders | Systematic Assessment |
|
| COVID-19 infection | Infections and infestations | Systematic Assessment |
|
| Neck pain/inflammation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Id reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |