Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

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.

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