LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis - Full Text View

Sponsored by:	NeoStrata Company, Inc.
Information provided by:	NeoStrata Company, Inc.
ClinicalTrials.gov Identifier:	NCT00705900

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

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental LCD Solution: 2 applications / day	Drug: LCD 2 applications / day for 12 weeks
2: Active Comparator Calcipotriol cream: 2 applications / day	Drug: calcipotriol 2 applications / day for 12 weeks

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

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

Keywords provided by NeoStrata Company, Inc.:

psoriasis

Study placed in the following topic categories:

Calcipotriene
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009