NCT00658788

Brief Summary

The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
305

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

12 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

Study Start

First participant enrolled

March 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

August 27, 2014

Completed
Last Updated

August 23, 2022

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

March 4, 2008

Results QC Date

August 12, 2014

Last Update Submit

July 28, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Overall Disease Severity Success (ODS)

    Success was defined as a one-grade improvement in ODS from baseline.

    8 and 12 weeks

Secondary Outcomes (11)

  • Global Improvement Score

    2, 4, 8 and 12 weeks

  • Signs of Psoriasis - Erythema

    2, 4, 8 and 12 weeks

  • Signs of Psoriasis - Scaling

    2, 4, 8 and 12 weeks

  • Signs of Psoriasis - Plaque Elevation

    2, 4, 8 and 12 weeks

  • Percent Change From Baseline in Body Surface Area (% BSA) Affected

    2, 4, 8 and 12 weeks

  • +6 more secondary outcomes

Study Arms (1)

Study Treatment

ACTIVE COMPARATOR

clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Drug: clobetasol propionate spray 0.05%Drug: calcitriol ointment

Interventions

clobetasol propionate spray 0.05%DRUG

clobetasol propionate spray, 0.05%, applied topically twice daily

Also known as: Clobex® Spray 0.05%
Study Treatment
calcitriol ointmentDRUG

calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Study Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
  • Overall Disease Severity of at least 3 (moderate)

You may not qualify if:

  • Surface area involvement too large (\>20% BSA)
  • Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, 30078, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

Mount Sinai Department of Dermatology

New York, New York, 10029, United States

Location

Northeastern Ohio Universities College of Medicine

Warren, Ohio, 44483, United States

Location

Central Sooner Research

Norman, Oklahoma, 73069, United States

Location

J&J Studies, Inc

College Station, Texas, 77840, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 75390, United States

Location

Virginia Clinical Research, Inc

Norfolk, Virginia, 23507, United States

Location

Dermatology Associates of Seattle, PLLC

Seattle, Washington, 98101, United States

Location

Madison Skin and Research, Inc

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Elizabeth M Nieman
Organization
Galderma Laboratories, L.P.
elizabeth.nieman@galderma.com
817-961-5000

Study Officials

  • Ronald W Gottschalk, MD

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2008

First Posted

April 15, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 23, 2022

Results First Posted

August 27, 2014

Record last verified: 2012-09

Locations

US(12)