Trial Outcomes & Findings for HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL (NCT NCT06149247)
NCT ID: NCT06149247
Last Updated: 2025-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
Valchlor (Mechlorethamine)
Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Valchlor (Mechlorethamine)
Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL
Baseline characteristics by cohort
| Measure |
HyBryte (0.25 % Hypericin)
n=5 Participants
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)
n=5 Participants
Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 19.18 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 13.48 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 16.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksA 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.
Outcome measures
| Measure |
HyBryte (0.25 % Hypericin)
n=5 Participants
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)
n=5 Participants
Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) Score
|
3 Participants
|
1 Participants
|
Adverse Events
HyBryte (0.25 % Hypericin)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Valchlor (Mechlorethamine)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HyBryte (0.25 % Hypericin)
n=5 participants at risk
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)
n=5 participants at risk
Valchlor (0.016% mechlorethamine) gel will be applied to CTCL lesions once daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Swollen lymph nodes
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Allergic contact dermatitis
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Dermatitis
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Rash
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
|
General disorders
Sensitivity
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
|
Infections and infestations
COVID-19 infection
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain/inflammation
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Id reaction
|
0.00%
0/5 • From enrollment until end of follow-up, up to 16 weeks
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to 16 weeks
|
Additional Information
Richard Straube, MD/Chief Medical Officer
Soligenix, Inc.
Phone: 609-538-8200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place