Evaluation of Efficacy, Duration of Remission and Safety of a Light and Occlusive Patch Therapy for Plaque Psoriasis

This is a multi-center, investigator blinded, randomized study designed to assess the
efficacy, duration of effect, safety and tolerability of Luma Light System for plaque
psoriasis. Two selected areas to be treated will be determined by the Investigator at
Baseline. Excluded areas include the palms, the soles of the feet, the intertriginous areas,
the knee, the elbow, the face and the scalp. Target Plaque Assessment (TPA), tolerability
assessment and any adverse events (AEs) will be obtained at each visit. The subject may use
topical prescriptions (steroids, vitamin D analogs, retinoids, etc.) for non-target plaques
during this trial with approval of the investigator as long as they keep a 1" border around
the target plaques where no prescription topical is applied. Any treatment that is not part
of the trial that the subject uses for psoriasis should be noted in the subject's file.

Start of Observation Phase with Screening Visit: Subjects will be given an IRB approved
consent to read and sign at the screening Visit. No study related procedures will be
performed prior to signing this consent. The Investigator will review the
inclusion/exclusion criteria, evaluate the Subject's medical history, before determining the
Subject's eligibility to participate in the study. A pregnancy test will be performed for
all females of childbearing potential at the Screening Visit. Prior to the trial start, each
subject will undergo a minimum 2 weeks or maximum of 13 weeks Observation Phase (starting
with Visit 1 Screening) during which the subject will be supplied a standard cleanser and
lotion in order to evaluate the stability of the plaque severity prior to entering the
Active Treatment Phase. The Observation Phase will be up to 13 weeks if the subject needs to
taper off an oral medication or biologic (see Washout and Excluded Medications section).

Start of Active Treatment Phase with Baseline Visit: If the Subject is determined to be
eligible for the study, he/she will return to the clinic for the Baseline Visit. At this
visit inclusion/exclusion criteria will be confirmed, patient will be enrolled in the study,
randomization of the plaques will occur and baseline assessments will be performed including
TPA. The test product will be dispensed, the user will be trained on how to use the product
and the first treatment will be applied.

The Active Treatment Phase will be 6 weeks or until target plaque has cleared, whichever
comes first. During the Active Treatment Phase, the plaque randomized to Arm B will receive
the active occlusive hydrogel patch and will be changed every 5 days or less as needed.
During the Active Treatment Phase, the plaque randomized to Arm A will receive the window
patch and replaced as needed. The light will be applied to the target plaque assigned to Arm
B every day with the hydrogel patch in place. The subject will return to the clinic every
two weeks (Visit 3, 4 and 5) for assessments. Subjects who terminate early will be asked to
complete all Week 6/ET assessments prior to commencement of any alternative therapy for
psoriasis (if possible). Subjects who discontinue from the study during the Active Treatment
Phase may be replaced and only will be followed if an AE is present.

Start of Follow-up Phase: Subjects will return for efficacy and safety follow-up visits at 8
week intervals after the Active Treatment Phase for 24 weeks (Visit 6, 7 and 8) to assess
durability of remission. If subject decides to start active treatment with a prescription
product on a plaque that was treated during the Active Treatment Phase (not including
supplied lotion and cleanser, shampoos for hair or their normal topical therapeutic products
to psoriatic areas that are not part of the study treatment areas) then that target plaque
will no longer considered to be in remission. No systemic treatments will be allowed during
the Follow-up Phase but if the subject or physician determines that it is necessary, the
subject will no longer be considered in remission at the time of commencement of the
systemic treatment. If the subject uses a prescription product on a target plaque or starts
a systemic treatment, the investigator will capture why this occurs.

Inclusion Criteria:

1. Male or female of any race, greater than 18 years of age.

2. Verbal and written informed consent obtained from the subject.

3. Has a clinical diagnosis of plaque psoriasis at the Screening and Baseline visits.

4. Has an IGA score of 2 to 4 that is consistent between the Screening and Baseline
visits.

5. TPA score of 5-12 and a score of at least 1 for each of the 3 different psoriasis
signs and symptoms (erythema, plaque elevation, and scaling) at the baseline visits.

6. Has at least 2 plaques of at least 6cm by 3cm with TPA scores not differing from each
other by a score of more than 1 that are at least 2 inches apart at the baseline
visit.

7. Is in good general health as determined by the Investigator based on the subject's
medical history.

8. Females of childbearing potential must have negative urine or blood 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.

9. Subject agrees to use only the Sponsor provided cleanser and lotion during the study
phase unless given permission by Investigator to use other topicals on non-target
plaques.

10. Subject is willing and able to return for all study visits.

Exclusion Criteria:

1. 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.

2. Presence of any concurrent skin condition that could interfere with the evaluation of
the study device, as determined by the Investigator.

3. Female who is pregnant, nursing an infant, or planning a pregnancy during the Active
Treatment Phase.

4. Treatment with any investigational drug or device within 2 weeks 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.

5. History of melanoma.

6. 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.

7. Subject has known allergy or adverse reaction to skin adhesives or hydrogels or coal
tar.