Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris

NCT ID: NCT01465282

Last Updated: 2013-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.05% (w/w) CT327 ointment

0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.

Group Type EXPERIMENTAL

CT327 0.05%

Intervention Type DRUG

0.05% CT327 (w/w) ointment

0.1% (w/w) CT327 ointment

0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.

Group Type EXPERIMENTAL

CT327 0.1%

Intervention Type DRUG

0.1% CT327 (w/w) ointment

0.5% (w/w) CT327 ointment

0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.

Group Type EXPERIMENTAL

CT327 0.5%

Intervention Type DRUG

0.5% CT327 (w/w) ointment

Placebo ointment

Placebo ointment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT327 0.05%

0.05% CT327 (w/w) ointment

Intervention Type DRUG

CT327 0.1%

0.1% CT327 (w/w) ointment

Intervention Type DRUG

CT327 0.5%

0.5% CT327 (w/w) ointment

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects aged at least 18 years.
* Stable psoriasis vulgaris

Exclusion Criteria

* Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Creabilis SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hotsprings, Arkansas, United States

Site Status

San Ramon, California, United States

Site Status

Bay City, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

South Euclid, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

San Antonio, Texas, United States

Site Status

Spanish Fork, Utah, United States

Site Status

Birmingham, , United Kingdom

Site Status

Cardiff, , United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Merseyside, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT327-2003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.