Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis
Information source: NeoStrata Company, Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: clobetasol + LCD (Drug); Clobetasol + Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: NeoStrata Company, Inc. Overall contact: Jerry Bagel, MD, Phone: (609) 443-4500, Email: njpsoriasis@aol.com
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.
Clinical Details
Official title: A Steroid-Sparing Effect of Supplemental LCD Treatment in Patients With Moderate-to-Severe Localized Psoriasis Lesions: a Pilot Study.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients who are clear (PGA score 0) or have minimal disease (PGA score 1) on each treated side at each visit.
Secondary outcome: Mean change in disease severity (using PGA score, erythema, scaling, induration, and overall severity scores of target lesions, %BSA involvement, and patient self-assessment of psoriasis symptoms)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jerry Bagel, MD, Phone: (609) 443-4500, Email: njpsoriasis@aol.com
Windsor Dermatology, East Windsor, New Jersey 08520, United States; Recruiting Jerry Bagel, MD, Phone: 609-443-4500, Email: njpsoriasis@aol.com Jerry Bagel, MD, Principal Investigator
Additional Information
Starting date: October 2008
Ending date: April 2009
Last updated: October 8, 2008
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