Evaluation of Efficacy, Duration of Remission and Safety of a Light and Occlusive Patch Therapy for Plaque Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03180866|
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Device: Luma Light System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The subject will act as their own control as one target plaque will receive treatment and one will not. This information will not be made available to the Investigators or the bio-statistician.|
|Official Title:||Evaluation of Efficacy, Duration of Remission and Safety of a Light and Occlusive Patch Therapy for Plaque Psoriasis|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
No Intervention: Non-treatment Control
Control arm will not have any intervention
Experimental: Luma Light System
The experimental arm will be a combination of an occlusive dressing and NBUVB light.
Device: Luma Light System
The Luma Light System combines a NBUVB light with an occlusive dressing.
- Target Plaque Assessment (TPA) at 6 weeks [ Time Frame: 6 weeks ]Local efficacy will be evaluated with a 0-4 point scale for three signs and symptoms of psoriasis: erythema, plaque elevation, and scaling. Change in TPA score will be used to measure the efficacy of the Luma Light System at 6 weeks after treatment initiation compared to control. TPA change scores will be computed by subtracting scores at baseline from scores at 6 weeks. It is hypothesized that the decline in TPA scores will be greater for the Luma Light System (Arm B) than for the control (Arm A).
- Frequency and severity of device and / or procedure related adverse events [ Time Frame: 6 weeks ]Profile the safety of the Luma Light System (Arm B) in terms of the frequency and severity of device and / or procedure related adverse events. Evaluation of adverse events, including significant changes from baseline in cutaneous tolerability (burning/stinging, pain, and pruritus) of a combination of a home NBUVB lamp with an occlusive hydrogel patch (Arm B).
- TPA at 2, 4, 22 and 30 weeks [ Time Frame: 2, 4, 22 and 30 weeks ]TPA measurement of efficacy at weeks 2, 4, 14, 22 and 30 of Luma Light System (Arm B) compared to control (Arm A). TPA change scores will be computed by subtracting scores at baseline from scores at each specified study visit.
- Duration of remission [ Time Frame: 30 weeks ]Duration of remission of plaques of the Luma Light System (Arm B) compared to control (Arm A). Duration of remission is defined by days between plaque clearing and whichever comes first: either the 30 week visit 8, withdrawal from the study for any reason or follow-up TPA score of 2 or higher. A plaque is considered cleared with a scale and thickness score of 0 and an erythema score of 1 or 0. If a plaque does not reach this score the remission duration will be zero.
- Subject Satisfaction [ Time Frame: 4 weeks ]Subject satisfaction with treatment and perceived plaque improvement of the Luma Light System (Arm B) at 4 weeks compared to control (Arm A).
- Compliance [ Time Frame: 6 weeks ]Compliance to Luma Light System (Arm B) in terms of percent daily treatments delivered.
- TPA less than 2 at 4 weeks [ Time Frame: 4 weeks ]Percentage of subjects who reach a TPA score of less than 2 in treatment Arms A and B in 4 and 6 weeks.
- TPA less than 2 at 6 weeks [ Time Frame: 6 weeks ]Percentage of subjects who reach a TPA score of less than 2 in treatment Arms A and B
- Subject Satisfaction [ Time Frame: 6 weeks ]Subject satisfaction with treatment and perceived plaque improvement of the Luma Light System (Arm B) at 6 weeks compared to control (Arm A).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180866
|Contact: Liza Marieemail@example.com|
|United States, California|
|Redwood Dermatology Research||Recruiting|
|Santa Rosa, California, United States, 95403|
|Contact: Liza Marie, RN 707-755-3946 firstname.lastname@example.org|
|Principal Investigator: Jeffrey Sugarman, MD, PhD|
|United States, Tennessee|
|Dermatology Associates of Knoxville, PC||Recruiting|
|Knoxville, Tennessee, United States, 37917|
|Contact: Kim Hall, CCRC 865-524-2547 ext 1136 email@example.com|
|Principal Investigator: Edward Primka, MD|
|United States, Texas|
|Texas Dermatology and Laser Specialists||Recruiting|
|San Antonio, Texas, United States, 78218|
|Contact: Kirsten Katz 210-852-2779 firstname.lastname@example.org|
|Contact: Gabe Leal 210-852-2779 email@example.com|
|Principal Investigator: John C Browning, MD|
|United States, Utah|
|Jordan Valley Dermatology Center||Recruiting|
|West Jordan, Utah, United States, 84008|
|Contact: Kristy Pincock, CRC 810-316-0266 firstname.lastname@example.org|
|Contact: Judy Stinson, LPN, CRC 810-316-0266 email@example.com|
|Principal Investigator: Douglas W Forsha, MD|