Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

OPKO Health

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: CTA018 cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384098

CTA018-CL-2001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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