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Completed

NCT Number: NCT00384098

Safety and Efficacy of Topically Applied CTA018 in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTA018 cream

Drug

Primary outcomes

  1. The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 4, 2006
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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