The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.
This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)
TKL Research Inc (Research Clinics Division)
Paramus, New Jersey, United States
Adverse Events
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
Time frame: 1 week
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