NCT01465282

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

November 1, 2011

Last Update Submit

March 7, 2013

Conditions

Psoriasis Vulgaris

Keywords

psoriasis vulgaristopical ointment

Outcome Measures

Primary Outcomes (1)

  • Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.

    Week 8

Secondary Outcomes (1)

  • Local and systemic toleration

    8 weeks

Study Arms (4)

0.05% (w/w) CT327 ointment

EXPERIMENTAL

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

Drug: CT327 0.05%

0.1% (w/w) CT327 ointment

EXPERIMENTAL

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

Drug: CT327 0.1%

0.5% (w/w) CT327 ointment

EXPERIMENTAL

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

Drug: CT327 0.5%

Placebo ointment

PLACEBO COMPARATOR

Placebo ointment

Drug: Placebo

Interventions

CT327 0.05%DRUG

0.05% CT327 (w/w) ointment

0.05% (w/w) CT327 ointment
CT327 0.1%DRUG

0.1% CT327 (w/w) ointment

0.1% (w/w) CT327 ointment
CT327 0.5%DRUG

0.5% CT327 (w/w) ointment

0.5% (w/w) CT327 ointment
PlaceboDRUG

Placebo

Placebo ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Hotsprings, Arkansas, United States

Location

Unknown Facility

San Ramon, California, United States

Location

Unknown Facility

Bay City, Michigan, United States

Location

Unknown Facility

Fridley, Minnesota, United States

Location

Unknown Facility

South Euclid, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Spanish Fork, Utah, United States

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Cardiff, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Merseyside, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

December 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

GB(5)US(8)