NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.

Detailed Description
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Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. This study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (LCD) (coal tar) solution to standard NB_UVB phototherapy in adults with chronic plaque psoriasis. Patients will apply LCD solution to half the body, twice daily at home and receive outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. Patients will rate their psoriasis symptoms and LCD solution aesthetics. Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, and effective and can improve psoriasis more quickly than NB-UVB light therapy alone.

Official Title
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A Clinical Evaluation of Safety & Efficacy of Adding an At-home Topical LCD Solution Regimen to Standard Narrowband UVB Phototherapy Administered 3 Times Weekly to Adults With Generalized Plaque Psoriasis.

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Other: LCD Solution with NB-UVB Phototherapy
* Device: NB-UVB Light Device (311-315 nm)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older able and willing to provide written informed consent symmetrical plaque psoriasis able and willing to attend phototherapy sessions and apply LCD at home negative pregnancy test for women of child-bearing potential Exclusion Criteria: current or recent other treatments for psoriasis hypersensitivity to LCD or UVB light current or previous skin cancer pregnant or nursing mother participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NB-UVB Light Device (311-315 nm)<br>the subject will receive full body NB-UVB light therapy | Device: NB-UVB Light Device (311-315 nm)<br>* NB-UVB Phototherapy: 3 light exposures / week<br>* Other names: Ultralite Model # V4848NB;|
| Experimental: LCD Solution with NB-UVB Phototherapy<br>on half of the body will receive LCD while the full body receives NB-UVB therapy | Other: LCD Solution with NB-UVB Phototherapy<br>* LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week<br>* Other names: LCD;Device: NB-UVB Light Device (311-315 nm)<br>* NB-UVB Phototherapy: 3 light exposures / week<br>* Other names: Ultralite Model # V4848NB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. | Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe). | 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions. | Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone. | 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis