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

This study has been completed.
Sponsor:
Information provided by:
NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:
NCT00705900
First received: June 25, 2008
Last updated: November 17, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention
Chronic Plaque Psoriasis
 Drug: LCD
Drug: calcipotriol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by NeoStrata Company, Inc.:

Primary Outcome Measures:
  • Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705900

Locations
United States, Massachusetts
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
  More Information

No publications provided by NeoStrata Company, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alexandra B. Kimball, MD, Massachusettes General Hospital / Brigham Women's Hospital
ClinicalTrials.gov Identifier: NCT00705900     History of Changes
Other Study ID Numbers: 06-LCDPOP
Study First Received: June 25, 2008
Last Updated: November 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by NeoStrata Company, Inc.:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Calcitriol
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013