Trial · NCT06149247
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
NCT06149247, Phase 2, Completed, Soligenix; results first posted 2025-08-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL. Trials, record NCT06149247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06149247
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
- NCT number
- NCT06149247
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Soligenix
- Conditions
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- Interventions
- Hypericin, Mechlorethamine Topical Gel
- First posted
- 2023-11-28
- Last updated
- 2025-08-20
- Results first posted
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | 12 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | HyBryte (0.25 % Hypericin) | 3 | Participants | ||
| Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | Valchlor (Mechlorethamine) | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HyBryte (0.25 % Hypericin) | 5 | |
| Overall Study | STARTED | Valchlor (Mechlorethamine) | 5 | |
| Overall Study | COMPLETED | HyBryte (0.25 % Hypericin) | 5 | |
| Overall Study | COMPLETED | Valchlor (Mechlorethamine) | 4 | |
| Overall Study | NOT COMPLETED | HyBryte (0.25 % Hypericin) | 0 | |
| Overall Study | NOT COMPLETED | Valchlor (Mechlorethamine) | 1 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Swollen lymph nodes | Blood and lymphatic system disorders | HyBryte (0.25 % Hypericin) | 1 | 5 | 1 |
| other | Swollen lymph nodes | Blood and lymphatic system disorders | Valchlor (Mechlorethamine) | 0 | 5 | 0 |
| other | Allergic contact dermatitis | General disorders | HyBryte (0.25 % Hypericin) | 0 | 5 | 0 |
| other | Allergic contact dermatitis | General disorders | Valchlor (Mechlorethamine) | 1 | 5 | 1 |
| other | Dermatitis | General disorders | HyBryte (0.25 % Hypericin) | 0 | 5 | 0 |
| other | Dermatitis | General disorders | Valchlor (Mechlorethamine) | 1 | 5 | 1 |
| other | Rash | General disorders | HyBryte (0.25 % Hypericin) | 0 | 5 | 0 |
| other | Rash | General disorders | Valchlor (Mechlorethamine) | 1 | 5 | 1 |
| other | Sensitivity | General disorders | HyBryte (0.25 % Hypericin) | 0 | 5 | 0 |
| other | Sensitivity | General disorders | Valchlor (Mechlorethamine) | 1 | 5 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HyBryte (0.25 % Hypericin) | 0 | 5 |
| Total, all-cause mortality | Valchlor (Mechlorethamine) | 0 | 5 |
| Total, other adverse events | HyBryte (0.25 % Hypericin) | 2 | 5 |
| Total, other adverse events | Valchlor (Mechlorethamine) | 3 | 5 |
| Total, serious adverse events | HyBryte (0.25 % Hypericin) | 0 | 5 |
| Total, serious adverse events | Valchlor (Mechlorethamine) | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41920467 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HyBryte (0.25 % Hypericin) vs Valchlor (Mechlorethamine): Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score | Trial comparisons |
| HyBryte (0.25 % Hypericin) vs Valchlor (Mechlorethamine): deaths from any cause | Trial comparisons |
| HyBryte (0.25 % Hypericin) vs Valchlor (Mechlorethamine): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06149247
GET https://conductscience.org/api/trials/v1/NCT06149247/registered