Laser-assisted Topical Administration of Etanercept (Enbrel®) in Patients With Mild to Moderate Plaque-type Psoriasis

Monocentric, observer partially-blinded Phase I study. In this study, three similar plaques on each patient will be prospectively identified by the blinded observer and then randomized by an unblinded investigator by using the eCRF to one of the three study treatments: 1. Standard of care (daily administration of Daivobet® by the patient), 2. Ablative fractional laser microporation + topical application of etanercept 3. Ablative fractional laser microporation alone. Over the treatment period of 8 weeks, patients will return to the clinic twice weekly for assessment of the three study plaques by the blinded observer, followed by administration of the treatment of plaques assigned to AFL microporation with or without etanercept. Patients will treat the remaining plaque with Daivobet® themselves on a daily basis. Although no incompatibilities of AFL and etanercept are anticipated, because this is the first time etanercept is administered topically via AFL micropores and using a AFL microporation device, the study will be conducted in two stages: a Safety Stage consisting of the first five patients and the Study Stage with thirty patients. In the Safety Stage of the study, three different plaques of the first 5 patients will be randomized and administered the respective treatments only once. Enrollment will be suspended after the 5th patient has been enrolled to permit the data monitoring committee (DMC) to review of the initial safety data from these first 5 patients to reassess risk. Based on this review, the DMC will make one of three recommendations: 1. to continue the study as planned, 2. to continue the study with adjustments to study procedures, such as changes to laser parameters, frequency of treatments or concentration of etanercept or, 3. in the event of extreme safety concerns, to terminate the study. If option 1 is recommended, the study will resume with the Study Stage (Stage 2), in which the initial 5 patients will once again begin treatment, with their plaques receiving the same treatments to which they were previously randomized. Their treatment will continue for 8 weeks. Enrollment will also resume and continue until an additional 25 patients have been enrolled. If the DMC recommends option 2, treatment and enrollment will resume as just described after an adapted protocol has been submitted to and approved by the relevant authorities. If the DMC recommends option 3, then the study will terminate. The Study Stage will consist of 2 periods: screening period (up to 2 weeks prior to baseline assessments and randomization) and treatment period (for the first 5 patients: initially 1 set of treatments, followed by suspension of treatment until after DMC review, then 8 weeks of treatment; for the remaining 25 patients: 8 weeks of treatment depending on plaque randomization, either daily Daivobet® or biweekly AFL with or without etanercept).