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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00705900
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : November 19, 2008
Information provided by:
NeoStrata Company, Inc.

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
Chronic Plaque Psoriasis Drug: LCD Drug: calcipotriol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: Dovonex Cream (50 mcg/g 0.005%)

Primary Outcome Measures :
  1. Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms [ Time Frame: 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 [ Time Frame: Week 12 and Week 18 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00705900

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United States, Massachusetts
Mass General Hospital: Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
NeoStrata Company, Inc.
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Principal Investigator: Alexandra B Kimball, MD Massachusettes General Hospital / Brigham Women's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alexandra B. Kimball, MD, Massachusettes General Hospital / Brigham Women's Hospital Identifier: NCT00705900     History of Changes
Other Study ID Numbers: 06-LCDPOP
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Keywords provided by NeoStrata Company, Inc.:
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents