LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 25, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedNovember 19, 2008
November 1, 2008
1.8 years
June 25, 2008
November 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms
12 weeks of treatment
Secondary Outcomes (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
Study Arms (2)
1
EXPERIMENTALLCD Solution: 2 applications / day
2
ACTIVE COMPARATORCalcipotriol cream: 2 applications / day
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- able and willing to provide written informed consent
- diagnosed with chronic plaque psoriasis
- % to 15% body surface area involved
- in good general health
You may not qualify if:
- other current treatments for psoriasis
- renal or liver dysfunction
- pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mass General Hospital: Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02114, United States
Related Publications (2)
Alora-Palli MB, Brouda I, Green B, Kimball AB. A cost-effectiveness comparison of liquor carbonis distillate solution and calcipotriol cream in the treatment of moderate chronic plaque psoriasis. Arch Dermatol. 2010 Aug;146(8):919-22. doi: 10.1001/archdermatol.2010.167. No abstract available.
PMID: 20713833DERIVEDAlora-Palli MB, Perkins AC, Van Cott A, Kimball AB. Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream. Am J Clin Dermatol. 2010;11(4):275-83. doi: 10.2165/11530380-000000000-00000.
PMID: 20513160DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra B Kimball, MD
Massachusettes General Hospital / Brigham Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2008
First Posted
June 27, 2008
Study Start
January 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
November 19, 2008
Record last verified: 2008-11