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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384098

Enrollment

140

Registered

2006-10-04

Start date

2006-09-30

Completion date

2007-05-31

Last updated

2014-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis

Brief summary

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.

Interventions

DRUGCTA018 cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026