Back to resultsEvaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vectical™ Ointment weekdays and Clobex® Spray weekends regimen
Clobex® Spray morning and Vectical™ Ointment evening regimen
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility 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.)
Sites / Locations
- Dermatology Research Associates
- Therapeutics Clinical Research
- Hudson Dermatology
- Minnesota Clinical Study Center
- Baylor Research Institute Dermatology Research
- Probity Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1) Vectical™ Ointment and Clobex® Spray
2) Clobex® Spray and Vectical™ Ointment
Arm Description
Vectical™ Ointment weekdays & Clobex® Spray weekends regimen
Clobex® Spray morning and Vectical™ Ointment evening regimen
Outcomes
Primary Outcome Measures
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Secondary Outcome Measures
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) 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. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.
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 (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4
Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "The treatment program was easy to follow" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am Satisfied with my Appearance" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am satisfied with the results of this treatment program" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I would use this treatment program again if recommended by the dermatologist" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00988637
Brief Title
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 once each morning and Vectical™ Ointment once each evening for 28 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1) Vectical™ Ointment and Clobex® Spray
Arm Type
Other
Arm Description
Vectical™ Ointment weekdays & Clobex® Spray weekends regimen
Arm Title
2) Clobex® Spray and Vectical™ Ointment
Arm Type
Other
Arm Description
Clobex® Spray morning and Vectical™ Ointment evening regimen
Intervention Type
Drug
Intervention Name(s)
Vectical™ Ointment weekdays and Clobex® Spray weekends regimen
Other Intervention Name(s)
calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%
Intervention Description
Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days
Intervention Type
Drug
Intervention Name(s)
Clobex® Spray morning and Vectical™ Ointment evening regimen
Other Intervention Name(s)
clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g
Intervention Description
Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
Primary Outcome Measure Information:
Title
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
Description
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2
Description
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame
Baseline to week 2
Title
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Description
Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.
Time Frame
Baseline to Week 4
Title
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Description
Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.
Time Frame
Baseline to Week 4
Title
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Description
Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame
Baseline to Week 4
Title
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Description
Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Time Frame
Baseline to Week 4
Title
Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
Description
Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4
Time Frame
Baseline to Week 4
Title
Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
Description
Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.
Time Frame
Baseline to Week 4
Title
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Description
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "The treatment program was easy to follow" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame
Baseline and Week 4
Title
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Description
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am Satisfied with my Appearance" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame
Week 4
Title
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Description
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am satisfied with the results of this treatment program" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame
Week 4
Title
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Description
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I would use this treatment program again if recommended by the dermatologist" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Time Frame
Week 4
Title
Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
Description
Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.
Time Frame
Baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Baylor Research Institute Dermatology Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Probity Medical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J1C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22106730
Citation
Hudson CP, Kempers S, Menter A, Papp K, Smith S, Sofen H, Colon LE, Johnson LA, Gottschalk R. An open-label, multicenter study of the efficacy and safety of a weekday/weekend treatment regimen with calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% in the management of plaque psoriasis. Cutis. 2011 Oct;88(4):201-7.
Results Reference
derived
PubMed Identifier
21877508
Citation
Menter A, Sofen H, Smith S, Papp K, Kempers S, Hudson CP, Colon LE, Johnson LA, Gottschalk R. An open-label, multicenter study of the efficacy and safety of an AM/PM treatment regimen with clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g in the management of plaque psoriasis. Cutis. 2011 Jul;88(1):46-51.
Results Reference
derived
Learn more about this trial
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
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