At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 169 enrolled
Drug / intervention
SGX301 (synthetic hypericin) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 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
In Brief
A Phase 3 clinical trial evaluating SGX301 (synthetic hypericin) and Placebo for Cutaneous T-Cell Lymphoma. Completed, enrolled 169 participants across 33 sites.
Detailed Summary
To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous T-Cell Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartDec 2015
Primary CompletionJun 2020
Study CompletionNov 2020
TodayJul 2026
First PostedMay 19, 2015
Enrollment StartDec 1, 2015
Primary CompletionJun 1, 2020
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.1 years ago
Interventions
SGX301 (synthetic hypericin)drug
0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.
Placebodrug
USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.