Last updated: 11/07/2018 08:15:05
Study to compare U0267 against Vehicle in subjects with Plaque-type Psoriasis two of two phase 3 studies
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267 , versus Vehicle Foam in Subjects with Plaque-type Psoriasis
Trial description: The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with treatment success, assessed per the Investigator's Static Global Assessment
Timeframe: 8 weeks
Secondary outcomes:
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
Timeframe: 8 Weeks
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
Timeframe: 8 Weeks
Number of subjects with a target lesion score of 0 for plaque thickness at week 8
Timeframe: 8 Weeks
Number of subjects who have an ISGA score of 0 or 1 at week 8
Timeframe: 8 Weeks
Number of subjects who have treatment success at week 8 analyzed by baseline ISGA (Mild or Moderate)
Timeframe: 8 Weeks
Interventions:
Drug: U0267 Foam
Drug: Vehicle foam
Enrollment:
323
Observational study model:
Not applicable
Primary completion date:
2008-26-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
calcipotriol
Collaborators
GSK
Study date(s)
March 2008 to December 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Male or female subjects at least 12 years old and in good general health.
- Mild to moderate plaque-type psoriasis
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
Academic Dermatology Associates
Albuquerque, NM, United States, 87106
Status
Study Complete
Location
Coastal Clinical Research, Inc.
Mobile, AL, United States, 36608
Status
Study Complete
Location
Center for Dermatology Cosmetic and Laser Surgery
Fremont, CA, United States, 94538
Status
Study Complete
Location
Dermatology Clinical Research Center of San Antonio
San Antonio, TX, United States, 78229
Status
Study Complete
Location
Wake Forest University Health Sciences
Winston Salem, NC, United States, 27157
Status
Study Complete
Location
The Center for Dermatology at Lifetime Health
Rochester, NY, United States, 14623
Status
Study Complete
Location
University Dermatology Consultants, Inc.
Cincinnati, OH, United States, 45219
Status
Study Complete
Location
Adult & Pediatric Dermatology
Overland Park, KS, United States, 66211
Status
Study Complete
Location
Oregon Dermatology and Research Center
Portland, OR, United States, 97210
Status
Study Complete
Location
The Skin Wellness Center, PC
Knoxville, TN, United States, 37922
Status
Study Complete
Location
Advanced Dermatology & Cosmetic Surgery
Ormond Beach, FL, United States, 32175
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-26-12
Actual study completion date
2008-26-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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