Comparison · NCT06149247-d4be0576
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT06149247-d4be0576. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06149247-d4be0576
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.6 | 0.231 | 0.882 | wilson | |
| Risk in group 2 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk difference, group 1 minus group 2 | 0.4 | -0.163 | 0.726 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.452 | 19.9 | log | |
| Odds ratio, group 1 over group 2 | 6 | 0.354 | 102 | log | |
| Number needed to treat, for one more participant with the outcome on HyBryte (0.25 % Hypericin) than on Valchlor (Mechlorethamine) | 2.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 3 | 5 | OG000 |
| Group 2 | Valchlor (Mechlorethamine) | Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks. | 1 | 5 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score
- Description
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.
- Time frame
- 12 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
- NCT number
- NCT06149247
- Phases
- PHASE2
- Conditions
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- Interventions
- Hypericin, Mechlorethamine Topical Gel
- Lead sponsor
- Soligenix
- Results first posted
- 2025-08-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06149247?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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