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

November 17, 2008 updated by: NeoStrata Company, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital: Clinical Unit for Research Trials in Skin

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 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

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms
Time Frame: 12 weeks of treatment
12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms
Time Frame: Week 12 and Week 18
Week 12 and Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoStrata Company, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (Estimate)

June 27, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2008

Last Update Submitted That Met QC Criteria

November 17, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-LCDPOP

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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