NCT06149247

HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Soligenix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to compare the safety and effectiveness of Valchlor versus HyBryte following 12 weeks of treatment.

Detailed description

Participants will be randomized to receive HyBryte or Valchlor in a 1:1 randomization. Participants will be treated for 12 weeks and follow-up visits will be conducted 1, 2, and 4 weeks after completion of the treatment phase of the trial. Prior to randomization, each participant will have at least 3 and up to 5 lesions identified (index lesions) that will be evaluated during the treatment phase and during the follow-up visits.

Conditions

• Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	Hypericin	HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.
DRUG	Mechlorethamine Topical Gel	Valchlor is an FDA-approved drug for the treatment of CTCL.

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-05-31
• Completion: 2024-06-27
• First posted: 2023-11-28
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study