Luma Light System Proof of Concept Study in Subjects With Mild to Moderate Psoriasis
A Proof of Concept, Investigator Blinded Study to Evaluate the Efficacy and Safety of a Novel Combination of a Home Narrow Band Ultraviolet B (NBUVB) Lamp With an Occlusive Dressing in Adult Subjects With Mild to Moderate Psoriasis Vulgaris
1 other identifier
interventional
10
1 country
1
Brief Summary
This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this 6 weeks study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedMay 20, 2015
May 1, 2015
4 months
May 14, 2015
May 18, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Target Plaque Assessment
Local efficacy will be evaluated with a 0-4 point scale for three signs and symptoms of psoriasis: erythema, plaque elevation, and scaling.
6 weeks
Local Skin Reactions
Tolerability will be evaluated through assessment of selected local signs and symptoms at the article-application site: Burning/stinging, pain and pruritus. Each sign or symptom will be graded at Baseline and each subsequent visit using a 0-3 scale (0 = none, 1 = mild, 2 = moderate, or 3 = severe).
6 weeks
Study Arms (4)
Non-treatment Control
NO INTERVENTIONControl arm will not have any intervention
Occlusive Dressing
ACTIVE COMPARATORAn off-the-shelf dressing occlusive dressing will be used as an active comparator.
Luma Light
ACTIVE COMPARATORA NBUVB light will be used as an active comparator.
Luma Light System
EXPERIMENTALThe experimental arm will be a combination of an occlusive dressing and NBUVB light.
Interventions
The Luma Light System combines a NBUVB light with an occlusive dressing.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Illumicure Inclead
Study Sites (1)
Redwood Family Dermatology
Santa Rosa, California, 95403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 18, 2015
Study Start
May 1, 2015
Primary Completion
September 1, 2015
Last Updated
May 20, 2015
Record last verified: 2015-05