Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

Condition(s) targeted: Plaque Psoriasis

Intervention: Vectical™ Ointment weekdays and Clobex® Spray weekends (Drug); Clobex® Spray morning and Vectical™ Ointment evening (Drug)

Phase: Phase 4

Status: Not yet 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:
Anita M Zacherl, RN, Phone: 817-961-5061, Email: anita.zacherl@galderma.com

This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0. 05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray

treatment twice daily on weekends (Sat - Sun) for 28 days

2. Clobex® Spray each morning and Vectical™ Ointment once each evening for 28 days

Official title: An Open-label, Multi-center, Randomized, Evaluator-Blinded Study to Evaluate the Safety and Efficacy of Two Treatment Regimens Involving Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05% in the Treatment of Moderate Plaque Psoriasis

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Number of participants who are Clear/Almost Clear of Plaque Psoriasis at Week 4 based on the Overall Disease Severity (ODS), full ordinal scale from Baseline to Week 4

Secondary outcome:

Number of participants who are Clear/Almost Clear of Plaque Psoriasis at Week 4 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 4

Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4

Number of participants with decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4

Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4

Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4

Percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4

Mean scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) at Baseline and Week 4

Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey questions at Week 4

Number of participants with Tolerability Assessments resulting in Adverse Events

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

Criteria:

Inclusion Criteria:

- Male or female subjects aged 18 to 80 years inclusive

- Subjects with an Overall Disease Severity of 3 (moderate)

- Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face,

groin, axillae and/or other intertriginous areas

- For concurrent medications, type and dose must have been stable for at least 3 months

prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator

Exclusion Criteria:

- Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable

upper intake level) and/or more than 1,000 mg/day of calcium

- Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other

intertriginous areas

- Subjects with a wash-out period for topical treatment less than 30 days (Any steroid

containing medication, dovonex, anthralin, tar and/or UVB treatment)

- Subjects with a wash-out period for systemic treatment less than 12 weeks

(corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)

- Subjects with non-plaque psoriasis or other related diseases not classified as plaque

psoriasis

- Subjects who foresee intensive UV exposure during the study (mountain sports, UV

radiation, sunbathing, etc.)

Anita M Zacherl, RN, Phone: 817-961-5061, Email: anita.zacherl@galderma.com

Therapeutics Clinical Research, San Diego, California 92123, United States

Dermatology Research Associates, Los Angeles, California 90045, United States

Hudson Dermatology, Evansville, Indiana 47714, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Probity Medical Research, Waterloo, Ontario N2J1C4, Canada

Baylor Research Institute Dermatology Research, Dallas, Texas 75246, United States

Starting date: October 2009
Ending date: October 2010
Last updated: October 1, 2009