Luma Light System Proof of Concept Study in Subjects With Mild to Moderate Psoriasis

This is an interventional treatment trial for Psoriasis Read More

Inclusion Criteria:

• Male or female of any race, 18 to 65 (inclusive) years of age.
• Verbal and written informed consent obtained from the subject.
• Has a clinical diagnosis of mild to moderate psoriasis at the Screening and Baseline visits.
• Has an IGA score of 2 or 3.
• Target plaque assessment (TPA) score between 6-9 and a score of at least 2 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling)
• Has at least 4 plaques of at least 10 cm2 with TPA scores not differing from each other by a score of more than 1
• Is in good general health as determined by the Investigator based on the subject's medical history, vital signs and physical examination.
• Females of childbearing potential must have negative urine pregnancy test results.
• Females of childbearing potential agree to use acceptable methods of contraception from the screening visit continuously until 30 days after end of treatment.
• Subject agrees to use only the Sponsor provided cleanser and lotion during the study period.
• Subject is willing and able to return for all study visits.

Exclusion Criteria:

• Presence of psoriasis that was previously treated with prescription medications prior to the Screening visit and was non-responsive to treatment, as determined by the Investigator.
• Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator.
• Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
• History of melanoma.
• Subject has any medical, social or psychological conditions that, in the opinion of the Investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.