Trial · NCT02448381
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
NCT02448381, Phase 3, Completed, Soligenix; results first posted 2022-04-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides). Trials, record NCT02448381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02448381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
- NCT number
- NCT02448381
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- Soligenix
- Conditions
- Cutaneous T-Cell Lymphoma
- Interventions
- SGX301 (synthetic hypericin), Placebo
- First posted
- 2015-05-19
- Last updated
- 2022-04-15
- Results first posted
- 2022-04-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo | 8 weeks | The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (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 was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome. |
| Secondary | Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) | 16 weeks | The percentage of patients achieving a treatment response at Week 16 that received SGX301 for both Cycle 1 and 2 compared to the response rate in patients that received Placebo in Cycle 1. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described. |
| Secondary | Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301 | 24 weeks | The percentage of patients achieving a treatment response at Week 24 compared at Week 16 in SGX301 treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described. |
| Secondary | Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo) | 16 weeks | The proportion of patch lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described. |
| Secondary | Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo) | 16 weeks | The proportion of plaque lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions. The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo | 8 weeks | The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) | 16 weeks | The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301 | 24 weeks | The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo) | 16 weeks | The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301) in Cycle 2 | lesions with response | NUMBER |
| SECONDARY | Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo) | 16 weeks | The analysis population was defined as all lesions that were treated with at least one dose of treatment (SGX301) in Cycle 2 | lesions with response | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo | SGX301 | Responder | 19 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo | Placebo | Responder | 2 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo | SGX301 | Non-responder | 97 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo | Placebo | Non-responder | 48 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) | SGX301 (Cycle 1 & 2 = SGX301) | Responder | 44 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) | Placebo (Cycle 1) | Responder | 2 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) | SGX301 (Cycle 1 & 2 = SGX301) | Non-responder | 66 | Participants | |
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo) | Placebo (Cycle 1) | Non-responder | 48 | Participants | |
Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301 | SGX301 (Cycle 1, 2 & 3 = SGX301) | Responder | 38 | Participants | |
Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301 | SGX301 (Cycle 1, 2 & 3 = SGX301) | Non-responder | 40 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SGX301 | 118 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | Randomized, Not Treated | SGX301 | 2 | |
| Overall Study | Randomized, Not Treated | Placebo | 1 | |
| Overall Study | Cycle 1 | SGX301 | 116 | |
| Overall Study | Cycle 1 | Placebo | 50 | |
| Overall Study | Cycle 2 | SGX301 | 110 | |
| Overall Study | Cycle 2 | Placebo | 45 | |
| Overall Study | Cycle 3 | SGX301 | 78 | |
| Overall Study | Cycle 3 | Placebo | 32 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events130
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 | Pruritus | Skin and subcutaneous tissue disorders | Cycle 1 - SGX301 | 6 | 116 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Cycle 1 - Placebo | 2 | 50 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Cycle 2 - SGX301 | 2 | 155 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Cycle 3 - SGX301 | 5 | 110 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Overall SGX301 | 12 | 161 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Cycle 1 - SGX301 | 3 | 116 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Cycle 1 - Placebo | 0 | 50 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Cycle 2 - SGX301 | 3 | 155 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Cycle 3 - SGX301 | 1 | 110 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Overall SGX301 | 7 | 161 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cycle 1 - SGX301 | 0 | 116 |
| Total, all-cause mortality | Cycle 1 - Placebo | 0 | 50 |
| Total, all-cause mortality | Cycle 2 - SGX301 | 0 | 155 |
| Total, all-cause mortality | Cycle 3 - SGX301 | 0 | 110 |
| Total, all-cause mortality | Overall SGX301 | 0 | 161 |
| Total, other adverse events | Cycle 1 - SGX301 | 56 | 116 |
| Total, other adverse events | Cycle 1 - Placebo | 26 | 50 |
| Total, other adverse events | Cycle 2 - SGX301 | 66 | 155 |
| Total, other adverse events | Cycle 3 - SGX301 | 49 | 110 |
| Total, other adverse events | Overall SGX301 | 108 | 161 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02448381
GET https://conductscience.org/api/trials/v1/NCT02448381/events?page=2