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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

Page last updated: February 12, 2009

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