This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) (NCT02448381), a randomized phase 3 study. The primary outcome is 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.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02448381 |
| Phase | Phase 3 |
| Condition | Cutaneous T-Cell Lymphoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 169 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Soligenix |
| Results posted | Yes |
2. Clinical Question
Population
Participants with patch/plaque phase cutaneous T-cell lymphoma, also called mycosis fungoides, were eligible for the study described in the record. The primary analysis population included participants treated with at least one dose of SGX301 or placebo. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
The active treatment was topical SGX301, or synthetic hypericin, followed by fluorescent-light irradiation. The treatment description specifies 0.25% SGX301 in ointment, applied twice per week, with three planned cycles. Each cycle was described as six weeks of treatment followed by a two-week rest period.
Comparator
Placebo ointment was described as indistinguishable from the active ointment and was used in Cycle 1. Its treatment approach, including ointment application and fluorescent-light therapy, was described as identical. The record says participants were randomized 2:1 to active treatment or placebo in Cycle 1.
Primary question
The primary question was whether the proportion of participants whose three treated lesions met the response criterion at Week 8 differed between the SGX301 and placebo groups. Response meant at least a 50% improvement in the combined CAILS score relative to baseline. The registry record does not report the response counts, percentages, treatment comparison estimate, confidence interval, or p-value.
3. Trial Design
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with a parallel-group model and quadruple masking recorded in the registry. The trial enrolled 169 participants and is listed as completed. The recorded start was 2015-12, and primary completion was 2020-06. The sponsor was Soligenix.
The study evaluated topical SGX301, a synthetic form of hypericin, together with fluorescent bulb-light irradiation in cutaneous T-cell lymphoma. The registry describes three treatment cycles. Each cycle was six weeks long, followed by a two-week rest period. Ointment was applied twice per week and followed by fluorescent-light therapy. The active ointment concentration was 0.25% in USP Hydrophilic Ointment. The placebo ointment was described as indistinguishable from the active ointment, and the Cycle 1 application and light-treatment approach was described as identical between groups.
For Cycle 1, the arm description states that participants were randomized 2:1 to active treatment or placebo and that three index lesions were assessed. The placebo was used only in Cycle 1. The registry lists SGX301 in Cycles 2 and 3, including an outcome comparing extended SGX301 treatment with Cycle 1 placebo. The record does not fully describe how participants moved between cycles, which participants entered each cycle, or the allocation procedures beyond the Cycle 1 description.
The primary endpoint timeframe was 8 weeks. The primary analysis population was defined as participants treated with at least one dose of either SGX301 or placebo. The record does not report the randomization sequence method, allocation concealment procedures, or the number of participants assigned to each arm at randomization.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | SGX301 | Placebo |
|---|---|---|
| STARTED | 118 | 51 |
| Randomized, Not Treated | 2 | 1 |
| Cycle 1 | 116 | 50 |
| Cycle 2 | 110 | 45 |
| Cycle 3 | 78 | 32 |
| Follow-up Period | 98 | 39 |
| COMPLETED | 83 | 32 |
| NOT COMPLETED | 35 | 19 |
Reasons for not completing this period:
| Reason | SGX301 | Placebo |
|---|---|---|
| Adverse Event | 2 | 0 |
| Lost to Follow-up | 16 | 9 |
| Physician Decision | 1 | 1 |
| Pregnancy | 1 | 0 |
| Withdrawal by Subject | 13 | 9 |
| Noncompliance with Study Procedures | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)
| Characteristic | Unit | SGX301 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 116 | 50 | 166 | |
| Age, Continuous | years | 57.9 (SD 15.94) | 59.4 (SD 16.26) | 58.4 (SD 16.00) |
| Sex: Female, Male: Female | Participants | 47 | 23 | 70 |
| Sex: Female, Male: Male | Participants | 69 | 27 | 96 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 | 3 | 13 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 103 | 45 | 148 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 | 2 | 5 |
| Race/Ethnicity, Customized: White | Participants | 84 | 36 | 120 |
| Race/Ethnicity, Customized: Black or African American | Participants | 27 | 12 | 39 |
| Race/Ethnicity, Customized: Asian | Participants | 4 | 0 | 4 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 2 | 2 |
| Race/Ethnicity, Customized: Unknown | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as 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, measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counted responders and non-responders according to change in the Composite Assessment of Index Lesion Disease Severity (CAILS) score. A response was defined as at least a 50% improvement at Week 8 compared with baseline. The measure combined scores for three treated lesions, and the endpoint was intended to compare the proportion meeting this response definition between SGX301 and placebo.
CAILS incorporates lesion redness, scaling, plaque elevation, and surface area. Redness and scaling each use a scale from 0 to 8; plaque elevation ranges from 0 to 3; and surface area ranges from 0 to 18. The total across three lesions ranges from 0 to 111. Lower scores indicate a better outcome. The response rule turns this severity measure into a binary outcome: each participant is classified as a responder or non-responder using the specified improvement threshold.
As a general statistical rationale, a binary response endpoint can make a treatment comparison straightforward to interpret as the proportion meeting a clinically defined criterion. It also discards some detail: two participants with different score changes can receive the same responder classification, and changes that do not cross the threshold are not distinguished by the binary result. The registry record does not report the primary response counts or percentages, so the observed treatment comparison and its precision cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of SGX301 with placebo during Cycle 1 and defines a response based on improvement in CAILS score at Week 8. However, the posted record does not include the primary outcome counts, group response percentages, effect estimate, confidence interval, or p-value. Consequently, it is not possible to describe the magnitude or direction of the primary treatment comparison from the registry information recorded. The absence of those results is distinct from evidence that the groups had equal outcomes.
The endpoint is defined at the participant level: a participant either met the improvement criterion for the combined score of three treated lesions or did not. The registry says the response threshold was at least a 50% improvement from baseline. The score itself incorporates redness, scaling, plaque elevation, and lesion surface area, with lower values representing better outcomes. These details explain what the endpoint was designed to capture, but they do not establish how many participants responded.
The record also lists secondary outcomes concerning response in the treated lesions, response among participants receiving three SGX301 cycles, and patch and plaque lesion response rates. It does not report the results for those outcomes in the information available for this analysis. Nor does it report estimates of treatment differences or uncertainty for them. The existence of named secondary outcomes should therefore not be mistaken for evidence about their observed values.
Safety information is available as counts for treatment-cycle groups. In Cycle 1, the registry records 1 serious event in the SGX301 group and 1 in the placebo group. It records 0 serious events in Cycle 2 SGX301 and 3 in Cycle 3 SGX301; the overall SGX301 grouping records 4. Deaths are recorded as 0 in each listed group. These are descriptive figures. The record does not provide a comparative statistical analysis of safety, and the cycle-specific groups should not be treated as independent randomized groups without further information about participant overlap and analysis methods.
General statistical interpretation requires both an estimate and information about its uncertainty. A confidence interval, when reported, describes a range of values compatible with the data under the analysis model; it does not guarantee that the true effect lies in that range. A p-value, when reported, addresses compatibility with a specified statistical null model and is not a measure of clinical importance. Neither a confidence interval nor a p-value for the primary comparison is reported in the registry record. No conclusion about statistical significance or precision can therefore be drawn from the primary results as posted.
The completed status and enrollment total describe the conduct recorded by the registry, not the outcome of the treatment comparison. The statistical interpretation is limited by the absence of posted efficacy results and by missing details about analysis procedures, missing observations, and how the repeated treatment cycles were handled.
9. Statistical Methods Explained
The primary outcome is a binary participant-level measure. Each participant is classified as a responder or non-responder using the prespecified endpoint definition in the registry: at least a 50% improvement in the CAILS score for three treated lesions at Week 8 compared with baseline. A comparison of binary outcomes commonly focuses on the proportion of participants who meet the criterion in each group. General statistical methods for such outcomes can estimate a difference or ratio between response proportions and quantify uncertainty, but the registry record does not report which effect measure or inferential procedure was used for the primary comparison.
What does the CAILS score represent?
CAILS combines four lesion features: erythema, scaling, plaque elevation, and surface area. The stated ranges are 0 to 8 for erythema, 0 to 8 for scaling, 0 to 3 for plaque elevation, and 0 to 18 for surface area. Scores for three lesions are added to form the overall score, which ranges from 0 to 111. The record states that a lower score means a better outcome. The response rule translates change in this combined score into a responder classification. As a general measurement point, reducing a continuous or ordered score to two categories can simplify communication, but it loses information about the size of changes within each category.
What would an uncertainty interval add?
General explanation: a confidence interval communicates the precision of an estimated treatment contrast. A narrow interval indicates more precision under the chosen model, while a wide interval indicates greater uncertainty. Its interpretation depends on the analysis method and assumptions. The registry record does not report a confidence interval for the primary response comparison, so neither its precision nor the range of effects compatible with that analysis can be assessed.
What does a p-value answer?
General explanation: a p-value is calculated relative to a null hypothesis and a statistical model. It indicates how unusual the observed data, or more extreme data, would be under that model if the null hypothesis were true. It does not measure the probability that the treatment is effective, the size of an effect, or its importance. The registry record does not report the primary p-value or enough analysis details to identify the testing procedure.
How should the cycle structure be considered?
The randomized placebo comparison is described for Cycle 1. Placebo was used only in that cycle, while the registry lists extended SGX301 treatment in later cycles. Outcomes that compare Cycle 1 and Cycle 2 SGX301 with Cycle 1 placebo therefore involve a different treatment period structure from a simple comparison conducted entirely within one cycle. General statistical practice requires the analysis to account for the design and the population contributing data at each time point. The registry record does not explain the analysis methods for these cycle-based outcomes or whether repeated observations from the same participants were modeled jointly.
The record lists five outcome measures and five analyses, but the primary outcome is not reduced to one comparison because it has several categories or time points. This means the posted information does not present a single primary statistical contrast suitable for a numerical interpretation. The specific contrasts, model, covariate adjustments, and handling of the multiple outcomes are not reported in the registry record.
What role does over-dispersion play?
General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It can arise in some count data or clustered outcomes, and ignoring it can make uncertainty appear too small. The primary endpoint is described as a count of participants classified into response categories, rather than a repeated event count per participant. The registry record does not report an over-dispersion assessment or an analysis model, so no claim can be made about whether this issue was considered.
The registry includes sample-size assumptions for a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and effects defined as fractions of the observed effect. Such calculations are planning illustrations, not observed power and not a report of the trial's original design rationale. No numeric planning estimates are reported in the information. The trial's own sample-size justification is not reported in the registry record.
For safety outcomes, the record gives serious-event and other-event counts by listed treatment group, along with deaths. These are descriptive summaries. General statistical comparisons of safety can depend on exposure time, event definitions, participant overlap, and the selected analysis population. The registry record does not report exposure-adjusted rates or a comparative inferential method for these safety figures.
10. Multiplicity, Missing Data and Analysis Populations
The record lists five outcome measures and five analyses, including the primary response endpoint and secondary outcomes involving treated-lesion response, three SGX301 cycles, and patch and plaque lesion response rates. When a study assesses multiple outcomes, time points, or contrasts, there may be more than one opportunity to observe a result that appears statistically notable by chance. General approaches to multiplicity include prespecifying a testing sequence or adjusting the criteria for inference, but the registry record does not report whether any such approach was planned or used.
The primary endpoint description specifies Week 8 and a response threshold, but the primary outcome is also identified as having several categories or time points and is not reduced to one comparison in the posted analyses. The registry record does not report which contrasts were designated primary for inference, whether tests were one- or two-sided, or how secondary outcomes were positioned relative to the primary outcome. Without those details and the numerical results, the evidence across outcomes cannot be interpreted as a unified confirmatory testing strategy.
The analysis population is described as all participants who received at least one dose of SGX301 or placebo. This is a treated-participant definition, not a statement that all randomized participants were analyzed as assigned. The registry record does not report how many randomized participants were excluded from the primary analysis, how participants with missing Week 8 measurements were handled, whether imputation was used, or whether sensitivity analyses assessed missing-data assumptions.
General explanation: missing data can affect a responder analysis if the chance of having an observed score is related to treatment or outcome. Different handling choices can lead to different estimates, especially when the response classification depends on both baseline and follow-up scores. The record does not report the amount or pattern of missing primary-outcome data, nor the methods used to address it. Randomization and masking are important design features, but they do not by themselves resolve missing-outcome concerns or define the analysis population.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Cycle 1 - SGX301 | 1 | 116 | 0.9% |
| Cycle 1 - Placebo | 1 | 50 | 2.0% |
| Cycle 2 - SGX301 | 0 | 155 | 0.0% |
| Cycle 3 - SGX301 | 3 | 110 | 2.7% |
| Overall SGX301 | 4 | 161 | 2.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cycle 1 - SGX301 | 0 of 116 |
| Cycle 1 - Placebo | 0 of 50 |
| Cycle 2 - SGX301 | 0 of 155 |
| Cycle 3 - SGX301 | 0 of 110 |
| Overall SGX301 | 0 of 161 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cycle 1 - SGX301 | 56 of 116 |
| Cycle 1 - Placebo | 26 of 50 |
| Cycle 2 - SGX301 | 66 of 155 |
| Cycle 3 - SGX301 | 49 of 110 |
| Overall SGX301 | 108 of 161 |
Most frequent serious adverse event terms
| Event term | Organ system | Cycle 1 - SGX301 | Cycle 1 - Placebo | Cycle 2 - SGX301 | Cycle 3 - SGX301 | Overall SGX301 |
|---|---|---|---|---|---|---|
| Gallbladder obstruction | Hepatobiliary disorders | 0 of 116 | 0 of 50 | 0 of 155 | 1 of 110 | 1 of 161 |
| Gastritis alcoholic | Gastrointestinal disorders | 1 of 116 | 0 of 50 | 0 of 155 | 0 of 110 | 1 of 161 |
| Cholecystitis | Hepatobiliary disorders | 0 of 116 | 0 of 50 | 0 of 155 | 1 of 110 | 1 of 161 |
| Pneumonia | Infections and infestations | 0 of 116 | 0 of 50 | 0 of 155 | 1 of 110 | 1 of 161 |
| Angioedema | Skin and subcutaneous tissue disorders | 0 of 116 | 1 of 50 | 0 of 155 | 0 of 110 | 0 of 161 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cycle 1 - SGX301 | Cycle 1 - Placebo | Cycle 2 - SGX301 | Cycle 3 - SGX301 | Overall SGX301 |
|---|---|---|---|---|---|---|
| Application site pain | General disorders | 8 of 116 | 2 of 50 | 5 of 155 | 6 of 110 | 16 of 161 |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | 9 of 116 | 1 of 50 | 5 of 155 | 5 of 110 | 17 of 161 |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | 6 of 116 | 2 of 50 | 4 of 155 | 5 of 110 | 14 of 161 |
| Upper respiratory tract infection | Infections and infestations | 8 of 116 | 4 of 50 | 2 of 155 | 2 of 110 | 12 of 161 |
| Pruritus | Skin and subcutaneous tissue disorders | 6 of 116 | 2 of 50 | 2 of 155 | 5 of 110 | 12 of 161 |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | 3 of 116 | 3 of 50 | 6 of 155 | 4 of 110 | 11 of 161 |
| Headache | Nervous system disorders | 5 of 116 | 3 of 50 | 5 of 155 | 2 of 110 | 10 of 161 |
| Viral upper respiratory tract infection | Infections and infestations | 4 of 116 | 0 of 50 | 4 of 155 | 4 of 110 | 11 of 161 |
| Application site pruritus | General disorders | 5 of 116 | 1 of 50 | 5 of 155 | 0 of 110 | 9 of 161 |
| Fatigue | General disorders | 3 of 116 | 1 of 50 | 3 of 155 | 2 of 110 | 8 of 161 |
Serious events with the highest arm-level rate: angioedema (2.0%), gallbladder obstruction (0.9%), cholecystitis (0.9%), pneumonia (0.9%), gastritis alcoholic (0.9%).
The registry reports serious adverse-event counts separately for Cycle 1 SGX301, Cycle 1 placebo, Cycle 2 SGX301, Cycle 3 SGX301, and overall SGX301. The respective serious-event counts are 1, 1, 0, 3, and 4. The corresponding numbers at risk are 116, 50, 155, 110, and 161. Deaths are recorded as 0 in every listed group. These figures describe what was recorded for each grouping; they do not, by themselves, establish a comparative treatment effect.
The registry also reports other adverse-event counts of 56 in Cycle 1 SGX301, 26 in Cycle 1 placebo, 66 in Cycle 2 SGX301, 49 in Cycle 3 SGX301, and 108 overall SGX301. The record's serious-event terms listed with percentages include angioedema at 2.0%, and gallbladder obstruction, cholecystitis, pneumonia, and alcoholic gastritis at 0.9% each.
Cycle-specific groups and the overall SGX301 group are distinct summaries, and the record does not explain participant overlap or exposure duration for these figures. The counts should not be added together or treated as independent comparisons. No exposure-adjusted safety rates, comparative confidence intervals, or safety p-values are reported. The listed percentages are quoted as recorded; their denominator and calculation details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study record documents a Phase 3 randomized, double-blind, placebo-controlled evaluation of topical SGX301 with fluorescent-light treatment for cutaneous T-cell lymphoma. It defines a primary response outcome based on improvement in CAILS score and describes the treatment schedule and analysis population. Those details establish what the investigators intended to assess, but they do not reveal the observed primary outcome.
The registry record does not report how many participants responded, the response percentage in either group, or the estimated contrast between SGX301 and placebo. It also does not report a confidence interval or p-value for that endpoint. Therefore, the posted information does not establish the direction, size, or precision of the primary efficacy comparison. It also cannot show that there was no difference: absent outcome results are not equivalent to a finding of no effect.
The safety summaries record serious events and other adverse events by cycle and overall SGX301 exposure, with no deaths recorded in the listed groups. These descriptive counts are not a complete comparative safety analysis. The relationship between cycle-specific and overall groupings, exposure time, and the basis for the listed percentages are not explained in the registry record. The figures should be read in that limited descriptive context.
General statistical interpretation distinguishes the estimate of an effect from the uncertainty around it, and both from the question of clinical importance. Even a statistically precise estimate would need to be interpreted in light of the endpoint, participants, design, and limitations. Here, the primary result and its precision are not reported, so that evaluation cannot be made. The registry record likewise does not report the analysis details needed to assess multiplicity, missing data, or the handling of measurements across treatment cycles.
The record supports statements about the study design, endpoint definition, and listed safety counts. It does not support a conclusion about whether SGX301 improved the primary outcome relative to placebo or about the magnitude of any such difference.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a clearly defined endpoint and a reported treatment result. The registry describes a participant-level response criterion based on CAILS change at Week 8, including the threshold, the three-lesion score, and the direction in which the score indicates improvement. Such detail makes the planned outcome understandable. Statistical interpretation still depends on seeing the response counts or estimates and their uncertainty, which are not reported in the registry record.
The treatment structure also matters to interpretation. The record describes a Cycle 1 placebo comparison followed by additional SGX301 treatment cycles, with secondary outcomes extending across treatment periods. Results from different cycles can address different questions and may involve different contributing participants or observation patterns. Without the analysis details, those questions cannot be collapsed into one treatment contrast.
Another statistical issue is the distinction between descriptive safety counts and comparative inference. The record gives counts by cycle and an overall SGX301 grouping, but does not report exposure-adjusted rates or explain overlap among these summaries. Treating such counts as if they were independent groups could misrepresent the data structure. Careful interpretation depends on knowing the denominator, exposure, and analysis method.
More broadly, a completed trial record can contain substantial design information while still leaving key evidence unavailable for evaluating the primary comparison. Registration details establish the study's scope and endpoint definition; numerical outcome estimates and transparent methods are needed to assess effect size and precision. This distinction is central when reading clinical-trial records and avoids treating study completion or enrollment as a substitute for posted results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for statistical interpretation is that the registry record does not report the primary response counts, group percentages, effect estimate, confidence interval, or p-value. It also does not provide the numerical results for the listed secondary outcomes. The direction and precision of the efficacy comparison therefore cannot be evaluated from the recorded information.
The primary outcome is identified as having several categories or time points and is not reduced to one comparison. The registry record does not explain the specific contrasts or analysis model used. It does not report whether covariates were included, how multiplicity was addressed, or whether analyses were prespecified in a statistical analysis plan.
The analysis population includes participants treated with at least one dose. The record does not report the number randomized to each arm, the number included in each outcome analysis, the amount of missing Week 8 data, or the methods used for missing observations. This limits assessment of the relationship between random assignment and the analyzed population.
The study included multiple treatment cycles, but the record does not fully describe participant flow between cycles or whether the same participants contributed to the cycle-specific and overall safety summaries. It also does not provide exposure duration or the denominator underlying the listed serious-event percentages. The safety figures are consequently descriptive and cannot be interpreted as exposure-adjusted comparisons.
The treatment description specifies three index lesions and a combined CAILS score, but the available record does not give additional details on assessment procedures or handling of lesion-level measurements. The registry record also does not report the trial's own sample-size justification. These limitations concern what can be assessed from the registry information, rather than establishing that particular procedures were or were not used.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides) — NCT02448381.
- Registry record last updated 2022-04-15; status last verified 2022-03.
- Results first posted 2022-04-15.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of topical SGX301 with fluorescent-light irradiation in cutaneous T-cell lymphoma. It enrolled 169 participants. Cycle 1 included SGX301 and placebo; placebo was used only in that cycle. The primary endpoint was responder status at Week 8, defined by at least a 50% improvement in the combined CAILS score for three treated lesions.
The primary analysis population was defined as participants who received at least one dose of treatment. The record lists secondary outcomes covering extended SGX301 treatment and lesion response. It reports serious and other adverse-event counts by treatment cycle and an overall SGX301 group, with 0 deaths recorded in each listed group.
The registry record does not report the primary efficacy results, their uncertainty, or sufficient statistical-analysis details to evaluate the treatment comparison. The posted information therefore supports a description of the design, endpoint, and listed safety counts, but not a conclusion about the primary efficacy result.