| February 16, 2007 |
| March 27, 2008 |
| February 2006 |
| July 2006 (final data collection date for primary outcome measure) |
| Efficacy - Change in Target Plaque Severity rating [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00437216 on ClinicalTrials.gov Archive Site |
- Efficacy - Self-Assessment of Quality of Life, Subject satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Safety - Evaluation of adverse events and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis |
| Phase 4 Open-Label Multicenter Community-Based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis |
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents. |
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4. |
| Phase IV |
| Observational |
| Case-Only, Other |
| Psoriasis |
- Drug: Clobetasol Propionate, 0.05%
- Drug: Clobetasol propionate, 0.05% Spray
|
- Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
- Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment
|
| |
| |
| Completed |
| 2488 |
| July 2006 |
| July 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
- At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
- History of stable plaque psoriasis of greater than or equal to 3 months
Exclusion Criteria:
- Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
- Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
- Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00437216 |
| Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P. |
| US10029 |
| Galderma Laboratories, L.P. |
|
| Study Director: |
Ronald W Gottschalk, MD |
Galderma Laboratories, LP |
|
|
| Galderma Laboratories, L.P. |
| March 2008 |
