Phase 4
Completed N=138
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Source: ClinicalTrials.gov NCT00988637 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: 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; 28 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
14; 28 | — |
| 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 |
9; 14 | — |
| SECONDARY Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 |
1; 0; 2; 6; 9; 6 | — |
| SECONDARY Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 |
5; 4; 6; 15; 31; 32 | — |
| SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 |
12; 20; 24; 20; 28; 23 | — |
| SECONDARY Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 |
6; 11; 15; 24; 33; 26 | — |
| SECONDARY Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4 |
-33.3; -50.0 | — |
| 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 |
-24.8; -27.5 | — |
| 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 |
61; 59; 2; 8; 2; 0 | — |
| 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 |
10; 25; 39; 32; 6; 4 | — |
| 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 |
23; 42; 35; 20; 5; 1 | — |
| 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 |
37; 50; 21; 16; 3; 0 | — |
| SECONDARY Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4 |
4; 2 | — |
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.)
Data sourced from ClinicalTrials.gov (NCT00988637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.