Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Cytochroma Inc.
ClinicalTrials.gov Identifier:
NCT00384098
First received: October 2, 2006
Last updated: June 25, 2007
Last verified: June 2007

October 2, 2006
June 25, 2007
September 2006
Not Provided
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
Same as current
Complete list of historical versions of study NCT00384098 on ClinicalTrials.gov Archive Site
Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
A Randomized, Double-Blind, Parallel-Group, 4-Arm, 12-Week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis

Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis
Drug: CTA018 cream
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
May 2007
Not Provided

Inclusion Criteria:

  • clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
  • at least two evaluable plaques with CPSS >/= 6
  • baseline PSGA >/= 2
  • women of childbearing potential msut agree to use an effective form of contraception

Exclusion Criteria:

  • cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
  • cannot have concomitant serious illness/condition that may interfere with participation in the study
  • cannot have used topical therapy within 2 weeks prior to baseline visit
  • cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
  • cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
  • cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit
  • cannot have a history of hypercalcemia or kidney stones
  • cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study
  • cannot be pregnant or a nursing mother
  • cannot be participating in or have participated in an interventional study within 30 days of study start
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00384098
CTA018-CL-2001
Not Provided
Not Provided
Cytochroma Inc.
Not Provided
Not Provided
Cytochroma Inc.
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP