Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
Sponsor: |
Soligenix |
Enrolling: |
Male and Female Patients |
Study Length: |
1 Years |
IRB Number: |
AAAR3953 |
U.S. Govt. ID: |
NCT02448381 |
Contact: |
Grace Ulerio: 212-305-6953 / gu2102@cumc.columbia.edu |
This is a phase 3 clinical trial to determine the efficacy of topical SGX301 (synthetic hypericin) in combination with visible light therapy on cutaneous T-cell lymphoma (CTCL). Selected subjects can participate in 3 cycles each consisting of a 6 week treatment period where a chosen lesion will be treated with the study ointment (twice a week) followed by light therapy the next day. All subjects will be seen monthly after their last treatment for 6 month to assess for any lesional changes. The study will include 2 skin biopsies and blood collections which will be used to measure the safety and efficacy of the drug. The study duration is approximately 1 year.
This study is closed
Investigator
Larisa Geskin, MD
Do you have CTCL in Stage 1A, Stage 1B, or Stage IIA? |
Yes |
No |
Do you have a minimum of three discrete lesions? |
Yes |
No |
Can you adhere to the study duration of approximately 1 year? |
Yes |
No |
(Female only) Are you pregnant or nursing? (If male, mark 'NO') |
Yes |
No |