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

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00988637

Purpose

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:

Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
Clobex® Spray each morning and Vectical™ Ointment once each evening for 28 days

Condition	Intervention	Phase
Plaque Psoriasis	Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends Drug: Clobex® Spray morning and Vectical™ Ointment evening	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Clobetasol Clobetasol propionate Calcitriol

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Number of participants with decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Mean scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) at Baseline and Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey questions at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Number of participants with Tolerability Assessments resulting in Adverse Events [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: Yes ]

Enrollment:	138
Study Start Date:	October 2009
Study Completion Date:	February 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1) Vectical™ Ointment and Clobex® Spray Vectical™ Ointment weekdays & Clobex® Spray weekends	Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends Vectical™ Ointment 3 µg/g twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days
2) Clobex® Spray and Vectical™ Ointment Clobex® Spray morning and Vectical™ Ointment evening	Drug: Clobex® Spray morning and Vectical™ Ointment evening Clobex® Spray 0.05% once each morning and Vectical™ Ointment 3 µg/g once each evening for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988637

Locations

United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Texas
Baylor Research Institute Dermatology Research
Dallas, Texas, United States, 75246
Canada, Ontario
Probity Medical Research
Waterloo, Ontario, Canada, N2J1C4

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10144
Study First Received:	October 1, 2009
Last Updated:	March 2, 2010
ClinicalTrials.gov Identifier:	NCT00988637 History of Changes
Health Authority:	United States: Institutional Review Board; Canada: Health Canada

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Cardiovascular Agents
Hormones
Glucocorticoids

Pharmacologic Actions
Calcitriol
Clobetasol
Membrane Transport Modulators
Psoriasis
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on March 16, 2010