Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
Status:
Terminated
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
This is an open label, single center, controlled study with each subject's two treatment
plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and
(b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no
treatment and serve as a control.
Subjects with at least three distinct, stable study plaque areas will receive the
experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the
lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission
is observed in a treatment plaque area then treatment of that area will be discontinued and
the area assessed weekly. A third plaque area (control plaque area) will receive no drug or
light treatment and serve as an internal control.
Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be
followed for a total of 16 weeks to allow assessment of Durability of Response of treated
lesions and comprehensive follow-up of adverse events.