Luma Light System Proof of Concept Study in Subjects With Mild to Moderate Psoriasis
NCT ID: NCT02447068
Last Updated: 2015-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Non-treatment Control
Control arm will not have any intervention
No interventions assigned to this group
Occlusive Dressing
An off-the-shelf dressing occlusive dressing will be used as an active comparator.
Occlusive Dressing
Off-the-shelf occlusive dressing
Luma Light
A NBUVB light will be used as an active comparator.
Luma Light
NBUVB light
Luma Light System
The experimental arm will be a combination of an occlusive dressing and NBUVB light.
Luma Light System
The Luma Light System combines a NBUVB light with an occlusive dressing.
Interventions
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Luma Light System
The Luma Light System combines a NBUVB light with an occlusive dressing.
Luma Light
NBUVB light
Occlusive Dressing
Off-the-shelf occlusive dressing
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Illumicure Inc
INDUSTRY
Responsible Party
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Locations
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Redwood Family Dermatology
Santa Rosa, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L-001
Identifier Type: -
Identifier Source: org_study_id
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