Plaque Psoriasis
Conditions
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: 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 once each morning and Vectical™ Ointment once each evening for 28 days
Interventions
DRUGVectical™ Ointment weekdays and Clobex® Spray weekends regimen
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
DRUGClobex® Spray morning and Vectical™ Ointment evening regimen
Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | 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 | 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 | 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 | 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 | Baseline to Week 4 | Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4 |
| 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 | 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 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 | Baseline and 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 | 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 | 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 | 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 | 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. |
| Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4 | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Dates of recruitment period: First subject was enrolled on October 26, 2009 and the last subject was enrolled on January 28, 2010.
Pre-assignment details
Wash-out period up to baseline is 30 days for any steroid containing medication, dovonex, anthralin, tar and/or ultraviolet B (UVB) treatment; 12 weeks for corticosteroids, biologics and/or psoralen + ultraviolet A (PUVA) treatment.
Participants by arm
| Arm | Count |
|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen | 70 |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen | 68 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | non-compliance with study drug | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Total |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 14.03 | 44.5 years STANDARD_DEVIATION 14.43 | 45.4 years STANDARD_DEVIATION 14.21 |
| Sex: Female, Male Female | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 43 Participants | 44 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 70 | 0 / 68 |
| serious Total, serious adverse events | 0 / 70 | 0 / 68 |
Outcome results
Primary
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.
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | 14 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | 28 participants |
Secondary
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.
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4 | -24.8 Units on a scale | Standard Deviation 22.81 |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4 | -27.5 Units on a scale | Standard Deviation 27.1 |
Secondary
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
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4 | -33.3 Percent change | Standard Deviation 31.85 |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4 | -50.0 Percent change | Standard Deviation 30.15 |
Secondary
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.
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Minimal Improvement (1) | 9 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Considerable Improvement (3) | 19 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | No change (0) | 2 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Clearing (4) | 13 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Definite Improvement (2) | 25 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Missing | 1 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Symptoms worse (-1) | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Missing | 3 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Symptoms worse (-1) | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | No change (0) | 6 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Minimal Improvement (1) | 6 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Definite Improvement (2) | 10 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Considerable Improvement (3) | 18 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 | Clearing (4) | 25 participants |
Secondary
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.
Time frame: Week 4
Population: ITT (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately agree | 39 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately disagree | 9 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly agree | 10 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly disagree | 3 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Missing | 3 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | No opinion | 6 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Missing | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly agree | 25 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately agree | 32 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | No opinion | 4 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately disagree | 5 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly disagree | 1 participants |
Secondary
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.
Time frame: Week 4
Population: ITT (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Missing | 3 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly agree | 23 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately agree | 35 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | No opinion | 5 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly disagree | 1 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately disagree | 3 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly disagree | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Missing | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | No opinion | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly agree | 42 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately disagree | 4 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately agree | 20 participants |
Secondary
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.
Time frame: Week 4
Population: ITT (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly agree | 37 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately agree | 21 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | No opinion | 3 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately disagree | 2 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly disagree | 4 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Missing | 3 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly disagree | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly agree | 50 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately disagree | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately agree | 16 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Missing | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | No opinion | 0 participants |
Secondary
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.
Time frame: Baseline and Week 4
Population: ITT (Intent to Treat)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly agree | 61 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately agree | 2 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | No opinion | 2 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Moderately disagree | 2 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Strongly disagree | 0 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | Missing | 3 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly disagree | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Strongly agree | 59 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately disagree | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Moderately agree | 8 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | Missing | 1 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | No opinion | 0 participants |
Secondary
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.
Time frame: Baseline to week 2
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | 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 | 9 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | 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 | 14 participants |
Secondary
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.
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat; LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Clear (0) | 5 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Mild (2) | 31 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Almost Clear (1) | 6 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Moderate (3) | 28 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Severe/Very Severe (4) | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Moderate (3) | 17 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Severe/Very Severe (4) | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Clear (0) | 4 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Almost Clear (1) | 15 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 | Mild (2) | 32 participants |
Secondary
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.
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Almost Clear (1) | 15 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Moderate (3) | 16 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Mild (2) | 33 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Severe/Very Severe (4) | 0 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Clear (0) | 6 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Severe/Very Severe (4) | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Clear (0) | 11 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Almost Clear (1) | 24 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Mild (2) | 26 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 | Moderate (3) | 7 participants |
Secondary
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.
Time frame: Baseline to Week 4
Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Almost Clear (1) | 24 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Moderate (3) | 6 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Mild (2) | 28 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Severe (4) | 0 participants |
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Clear (0) | 12 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Severe (4) | 0 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Clear (0) | 20 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Almost Clear (1) | 20 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Mild (2) | 23 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 | Moderate (3) | 5 participants |
Secondary
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.
Time frame: Baseline to Week 4
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends) | Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4 | 4 participants |
| Clobex® Spray (Morning) and Vectical® Ointment (Evening) | Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4 | 2 participants |