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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creabilis SA
ClinicalTrials.gov Identifier:
NCT01465282
First received: November 1, 2011
Last updated: March 7, 2013
Last verified: March 2013

November 1, 2011
March 7, 2013
December 2011
September 2012   (final data collection date for primary outcome measure)
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465282 on ClinicalTrials.gov Archive Site
Local and systemic toleration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis Vulgaris
  • Drug: CT327 0.05%
    0.05% CT327 (w/w) ointment
  • Drug: CT327 0.1%
    0.1% CT327 (w/w) ointment
  • Drug: CT327 0.5%
    0.5% CT327 (w/w) ointment
  • Drug: Placebo
    Placebo
  • Experimental: 0.05% (w/w) CT327 ointment
    0.05% (w/w) CT327 ointment applied BID for up to 8 weeks.
    Intervention: Drug: CT327 0.05%
  • Experimental: 0.1% (w/w) CT327 ointment
    0.1% (w/w) CT327 ointment applied BID for up to 8 weeks.
    Intervention: Drug: CT327 0.1%
  • Experimental: 0.5% (w/w) CT327 ointment
    0.5% (w/w) CT327 ointment applied BID for up to 8 weeks.
    Intervention: Drug: CT327 0.5%
  • Placebo Comparator: Placebo ointment
    Placebo ointment
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
NCT01465282
CT327-2003
No
Creabilis SA
Creabilis SA
Not Provided
Not Provided
Creabilis SA
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP