Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

Condition(s) targeted: Psoriasis

Intervention: clobetasol propionate spray 0.05% (Drug); calcitriol ointment (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

Overall contact:
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com

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.

Official title: A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score

Secondary outcome:

Efficacy - Percent of Subjects with an improvement from baseline in Overall Disease Severity score

Efficacy - Overall Disease Severity, Global Improvement Score, Signs of Psoriasis, Percent change from baseline in Body Surface Area

Efficacy - Koo-Menter Psoriasis Qualify of Life Questionnaire; Subject Satisfaction Survey

Safety - Tolerability, adverse events

Detailed description: Same as above.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body

surface area

- Overall Disease Severity of at least 3 (moderate)

Exclusion Criteria:

- Surface area involvement too large (>20% BSA)

- Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com

Therapeutics Clinical Research, San Diego, California 92123, United States; Recruiting
Angie Owens, Phone: 858-571-6800, Email: aowens@therapeuticsresearch.comm
Stacy Smith, MD, Principal Investigator

MedaPhase, Inc., Newnan, Georgia 30263, United States; Recruiting
Karen Mangieri, Phone: 770-252-6900, Email: kmangieri@medaphase.com
Mark Ling, MD, Principal Investigator

Gwinnett Clinical Research Center, Inc, Snellville, Georgia 30078, United States; Recruiting
Linda Davis, Phone: 770-972-2241, Email: gcrcinc@bellsouth.net
Jonathan S Weiss, MD, Principal Investigator

Hudson Dermatology, Evansville, Indiana 47714, United States; Recruiting
Kim Morrison, Phone: 812-426-9390, Email: hudsonderm@aol.com
Charles P Hudson, MD, Principal Investigator

Mount Sinai Department of Dermatology, New York, New York 10029, United States; Recruiting
Giselle Singer, Phone: 212-241-9728, Email: Giselle.singer@mssm.edu
Orit Markowitz, MD, Principal Investigator

Northeastern Ohio Universities College of Medicine, Warren, Ohio 44483, United States; Recruiting
Sandy Trevelen, Phone: 330-550-1940, Email: sltreleven@aol.com
Robert T Brodell, MD, Principal Investigator

Central Sooner Research, Norman, Oklahoma 73069, United States; Recruiting
Gena Fletcher, Phone: 405-329-0474, Email: gfletcher@centralsooner.com
Paul S Gillum, MD, Principal Investigator

Suzanne Bruce and Associates, PA, Houston, Texas 75390, United States; Recruiting
Sandy Nero, Phone: 713-850-0240, Email: snero@sba-skincare.com
Suzanne Bruce, MD, Principal Investigator

J&J Studies, Inc, College Station, Texas 77840, United States; Recruiting
Jeremy Scott, Phone: 979-774-5933, Email: jscott@js-studies.com
Terry Jones, MD, Principal Investigator

Virginia Clinical Research, Inc, Norfolk, Virginia 23507, United States; Recruiting
Becky Heroux, Phone: 757-625-0151, Email: bheroux@virginiaclinicalresearch.com
Robert Pariser, MD, Principal Investigator

Dermatology Associates of Seattle, PLLC, Seattle, Washington 98101, United States; Recruiting
Rebekah Lysaker, Phone: 206-267-2100, Email: rebekah@DASeattle.com
Bernard S Goffee, MD, Principal Investigator

Madison Skin and Research, Inc, Madison, Wisconsin 53719, United States; Recruiting
Mary Sharata, Phone: 608-826-0251, Email: Msharata@madskin.com
Harry Sharata, MD, Principal Investigator

Starting date: March 2008
Ending date: June 2009
Last updated: August 8, 2008