Phase 3
Completed N=305
Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
Source: ClinicalTrials.gov NCT00658788 ↗Enrolled (actual)
305
Serious AEs
2.9%
Results posted
Aug 2014
Primary outcomePrimary: Overall Disease Severity Success (ODS) — 100.0; 84.1 percentage of participants
Summary
The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Disease Severity Success (ODS) |
100.0; 84.1 | — |
| SECONDARY Global Improvement Score |
1; 0; 0; 0; 4; 2 | — |
| SECONDARY Signs of Psoriasis - Erythema |
0; 9; 13; 12; 46; 81 | — |
| SECONDARY Signs of Psoriasis - Scaling |
25; 41; 36; 31; 61; 83 | — |
| SECONDARY Signs of Psoriasis - Plaque Elevation |
22; 46; 35; 24; 69; 78 | — |
| SECONDARY Percent Change From Baseline in Body Surface Area (% BSA) Affected |
20.1; 43.1; 46.6; 46.2 | — |
| SECONDARY Overall Disease Severity |
0; 5; 9; 11; 53; 100 | — |
| SECONDARY Tolerability Assessment - Pruritus |
74; 179; 220; 172; 128; 84 | — |
| SECONDARY Tolerability Assessment - Telangiectasias |
303; 284; 283; 273; 230; 1 | — |
| SECONDARY Tolerability Assessment - Stinging/ Burning |
200; 232; 245; 234; 200; 44 | — |
| SECONDARY Tolerability Assessment - Skin Atrophy |
303; 286; 278; 270; 233; 2 | — |
| SECONDARY Tolerability Assessment - Folliculitis |
303; 286; 274; 271; 232; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
- Overall Disease Severity of at least 3 (moderate)
Exclusion Criteria
- Surface area involvement too large (>20% BSA)
- Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas
Data sourced from ClinicalTrials.gov (NCT00658788). 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.