Chronic Plaque Psoriasis Clinical Trial
Official title:
A Randomized, Single-Blind, Active Control, 18-Week Study to Evaluate the Safety and Efficacy of A New Twice-Daily, Topically Applied LCD Solution vs. Calcipotriol Cream for the Treatment of Adult Subjects With Moderate Plaque Psoriasis
Verified date | November 2008 |
Source | NeoStrata Company, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the safety and effectiveness of a new topical LCD solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms of plaque psoriasis and improving the quality of life in adults.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or older - able and willing to provide written informed consent - diagnosed with chronic plaque psoriasis - 3% to 15% body surface area involved - in good general health Exclusion Criteria: - other current treatments for psoriasis - renal or liver dysfunction - pregnant or nursing |
Country | Name | City | State |
---|---|---|---|
United States | Mass General Hospital: Clinical Unit for Research Trials in Skin | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
NeoStrata Company, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms | 12 weeks of treatment | ||
Secondary | Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms | Week 12 and Week 18 |
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