Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

NCT ID: NCT00769184

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-04-30

Brief Summary

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

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Corticosteroid + LCD

corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)

Group Type: EXPERIMENTAL

Corticosteroid

Intervention Type: DRUG

One side of body:

clobetasol: 2 applications / day along with LCD application 2 applications/day

LCD

Intervention Type: DRUG

One side of body:

LCD Solution: 2 applications / day along with clobetasol 2 applications/day

Corticosteroid + Placebo

corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks)

Group Type: PLACEBO_COMPARATOR

Corticosteroid

Intervention Type: DRUG

One side of body:

clobetasol: 2 applications / day along with LCD application 2 applications/day

Placebo

Intervention Type: OTHER

One side of body:

Placebo Solution: 2 applications / day along with clobetasol 2 applications/day

Interventions

Corticosteroid

One side of body:

clobetasol: 2 applications / day along with LCD application 2 applications/day

Intervention Type: DRUG

Placebo

One side of body:

Placebo Solution: 2 applications / day along with clobetasol 2 applications/day

Intervention Type: OTHER

LCD

One side of body:

LCD Solution: 2 applications / day along with clobetasol 2 applications/day

Intervention Type: DRUG

Other Intervention Names

clobetasol; liquor carbonis distillate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeoStrata Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Bagel, MD

Role: PRINCIPAL_INVESTIGATOR

Psoriasis Treatment Center of Central New Jersey

Locations

Windsor Dermatology

East Windsor, New Jersey, United States

Countries

United States

Other Identifiers

08-LCDSTRD

Identifier Type: -

Identifier Source: org_study_id