Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
This study has been completed.
Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00688519
First received: May 29, 2008
Last updated: April 12, 2012
Last verified: April 2012
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Purpose
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: U0267 Drug: Vehicle |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267, Versus Vehicle in Subjects With Plaque-type Psoriasis |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
Secondary Outcome Measures:
- Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.
- Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.
- Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.
- Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.
- Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
| Enrollment: | 336 |
| Study Start Date: | March 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: U0267 Foam
U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Drug: U0267
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
|
|
Placebo Comparator: Vehicle foam
Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
|
Drug: Vehicle
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects at least 12 years old and in good general health.
- Mild to moderate plaque-type psoriasis
Exclusion Criteria:
- Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
- History of hypercalcemia or of vitamin D toxicity.
- Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
- Other serious skin disorder or any chronic medical condition that is not well controlled.
- Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
- Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
- Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
- Use of any investigational therapy within 4 weeks of enrollment.
- Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688519
Locations
| United States, California | |
| Therapeutics Clinical Research Center, Inc. | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Cherry Creek Research, Inc. | |
| Denver, Colorado, United States, 80209 | |
| United States, Florida | |
| FXM Research | |
| Miami, Florida, United States, 33175 | |
| Florida Academic Dermatology Centers | |
| Miami, Florida, United States, 33136 | |
| United States, Kentucky | |
| DermResearch, PLLC | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Clinical Unit for Research Trials in Skin | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, New York | |
| Mount Sinai School of Medicine, Department of Dermatology | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Dermatology Consulting Services | |
| High Point, North Carolina, United States, 27262 | |
| United States, Oregon | |
| Oregon Medical Research Center, P.C. | |
| Portland, Oregon, United States, 97223 | |
| United States, Texas | |
| Dermatology Treatment & Research Center | |
| Dallas, Texas, United States, 75230 | |
| The Center for Skin Research | |
| Houston, Texas, United States, 77056 | |
| United States, Utah | |
| Dermatology Research Center, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline ( Stiefel, a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT00688519 History of Changes |
| Other Study ID Numbers: | 114741, U0267-301 |
| Study First Received: | May 29, 2008 |
| Results First Received: | November 5, 2010 |
| Last Updated: | April 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Plaque-type Psoriasis Psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013