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LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis

Sponsor
NeoStrata Company, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00705900
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
22
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

LCD Solution: 2 applications / day

Drug: LCD
2 applications / day for 12 weeks
Active Comparator: 2

Calcipotriol cream: 2 applications / day

Drug: calcipotriol
2 applications / day for 12 weeks
Other Names:
  • Dovonex Cream (50 mcg/g 0.005%)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms [12 weeks of treatment]

    Secondary Outcome Measures

    1. Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms [Week 12 and Week 18]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mass General Hospital: Clinical Unit for Research Trials in Skin Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • NeoStrata Company, Inc.

    Investigators

    • Principal Investigator: Alexandra B Kimball, MD, Massachusettes General Hospital / Brigham Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00705900
    Other Study ID Numbers:
    • 06-LCDPOP
    First Posted:
    Jun 27, 2008
    Last Update Posted:
    Nov 19, 2008
    Last Verified:
    Nov 1, 2008
    Keywords provided by , ,
    psoriasis
    Additional relevant MeSH terms:
    Psoriasis
    Calcipotriene

    Study Results

    No Results Posted as of Nov 19, 2008