- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00769184
Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis
July 22, 2015 updated by: NeoStrata Company, Inc.
A Steroid-Sparing Effect of Supplemental LCD Treatment in Patients With Moderate-to-Severe Localized Psoriasis Lesions: a Pilot Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
East Windsor, New Jersey, United States, 08520
- Windsor Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Corticosteroid + LCD
corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks)
|
One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day
Other Names:
One side of body: LCD Solution: 2 applications / day along with clobetasol 2 applications/day
Other Names:
|
Placebo Comparator: Corticosteroid + Placebo
corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks)
|
One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day
Other Names:
One side of body: Placebo Solution: 2 applications / day along with clobetasol 2 applications/day |
What is the study measuring?
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.
Time Frame: Weeks 2, 6, & 12.
|
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
Time Frame: Weeks 2, 6, & 12
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jerry Bagel, MD, Psoriasis Treatment Center of Central New Jersey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
October 7, 2008
First Submitted That Met QC Criteria
October 8, 2008
First Posted (Estimate)
October 9, 2008
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
July 22, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-LCDSTRD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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