Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

Study Overview
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Brief Summary
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This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis.

Detailed Description
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Superpotent topical corticosteroids such as clobetasol propionate are highly effective in treating plaque psoriasis but are not indicated for long term use due to their side effects. Therefore, steroid-sparing combination and sequential regimens, in which the corticosteroid gets supplemented with a non-steroid medication, such as calcipotriol or tazarotene, have become the standard of care, especially in the management of localized psoriasis lesions. A new steroid-free 15% liquor carbonis distillate (LCD) solution (Psorent) was recently found to be more successful than 0.005% calcipotriol cream (Dovonex) at improving and delaying worsening of psoriasis symptoms in a controlled clinical trial. The goal of this pilot study is to evaluate if this LCD solution can be used in combination with acute topical corticosteroid therapy as a new steroid-sparing / enhancing regimen. We hope to explore the compatibility, patient tolerability, and clinical benefit of using LCD solution during and after treatment with clobetasol propionate in adults with moderate to severe plaque psoriasis. This is a randomized, double-blind, vehicle-controlled, bilateral study. Men and women 18 years of age or older, with chronic plaque psoriasis affecting less than or equal to 10% body surface area (BSA) in areas other than the scalp, face, palms, soles, axillae, and groin, are recruited. Those with a Physician Global Assessment (PGA) score greater than 3 and are in general good health will qualify as candidates. On one side of the body, LCD solution and clobetasol propionate will be administered twice daily for the first 2 weeks of treatment, followed by 4 weeks of LCD solution only, followed by 6 weeks of no treatment. On the second half of the body, subject will apply a vehicle solution and clobetasol propionate twice daily for the first 2 weeks, only the vehicle solution twice daily for the next four weeks, and then no treatment for the next 6 weeks. Subjects will be evaluated at weeks 2, 4, 6, 8, 10 and 12. investigators will use the PGA scale [Clear (0) - Severe (5)] to determine treatment effects as well as Target Lesion assessments of Erythema, Scaling, Induration and overall severity [None (0) - Very Severe (4)]. patients will also be required to complete Self-Assessment questionnaires on their psoriasis [None (0) - Severe (6)]. as well as an assessment of the study solution [Excellent (9) - Poor (1)]. . Photographs will be taken at each study visit and adverse events will be monitored throughout the study.

Official Title
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A Steroid-Sparing Effect of Supplemental LCD Treatment in Patients With Moderate-to-Severe Localized Psoriasis Lesions: a Pilot Study.

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Corticosteroid
* Other: Placebo
* Drug: LCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older able to provide written informed consent able to attend study visits, apply medications, and follow instructions moderate to severe localized plaque psoriasis lesions (<10% BSA on each side of the body) Exclusion Criteria: other current treatments for psoriasis hypersensitivity to steroids, liquor carbonis detergens, alcohol, fragrance pregnant or nursing

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid + LCD<br>corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks) | Drug: Corticosteroid<br>* One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day<br>* Other names: clobetasol;Drug: LCD<br>* One side of body: LCD Solution: 2 applications / day along with clobetasol 2 applications/day<br>* Other names: liquor carbonis distillate;|
| Placebo Comparator: Corticosteroid + Placebo<br>corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks) | Drug: Corticosteroid<br>* One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day<br>* Other names: clobetasol;Other: Placebo<br>* One side of body: Placebo Solution: 2 applications / day along with clobetasol 2 applications/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12. | Weeks 2, 6, & 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval. | Weeks 2, 6, & 12 | 

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