Last updated: 11/03/2018 16:50:56
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis
GSK study ID
114569
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
Trial description: The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
At least a one grade improvement for the target psoriasis lesion on the elbow or knee (Psoriasis Grading Scale)
Timeframe: Baseline to day 15
Secondary outcomes:
At least 1 grade improvement Psoriasis Grading Scale
Timeframe: Baseline, days 3 and 8
At least a 2 grade improvement Psoriasis Grading Scale
Timeframe: Baseline, days 3, 8, 15
At least a 3 grade improvement Psoriasis Grading Scale
Timeframe: Baseline, days 3, 8, 15
At least 1 grade improvement in the Psoriasis Global Assessment
Timeframe: Baseline, days 3, 8, 15
At least a 2 grade improvement in the Psoriasis Global Assessment
Timeframe: Baseline, days 3, 8, 15
At least a 3 grade improvement in the Psoriasis Global Assessment
Timeframe: Baseline, days 3, 8, 15
At least 1 grade improvement in Subject’s Global Assessment
Timeframe: Baseline, days 3, 8, 15
At least a 2 grade improvement in Subject's Global Assessment
Timeframe: Baseline, days 3, 8, 15
At least a 3 grade improvement in Subject's Global Assessment
Timeframe: Baseline, days 3, 8, 15
Median change in Psoriasis Grading Scale
Timeframe: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Symptoms and Feelings
Timeframe: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Daily Activities
Timeframe: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Leisure
Timeframe: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Work and School
Timeframe: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Personal Relationships
Timeframe: Baseline, Days 3, 8, 15
Dermatology Quality of Life - Treatment
Timeframe: Baseline, Days 3, 8, 15
Total Dermatology Life Quality Index (DLQI) Score
Timeframe: Baseline, Days 3, 8, 15
Dermatology Life Quality Index (DLQI) Categories
Timeframe: Days 3, 8, 15
Interventions:
Drug: Olux-E Foam
Drug: Clobex lotion
Enrollment:
34
Observational study model:
Not applicable
Primary completion date:
2009-29-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Plaque-Type Psoriasis
Product
clobetasol
Collaborators
GSK
Study date(s)
March 2009 to June 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Body surface area (BSA) affected with psoriasis between 4% and 20% .
- Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
- Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
- Other serious skin disorder or any chronic medical condition that is not well controlled.
Inclusion and exclusion criteria
Inclusion criteria:
- Body surface area (BSA) affected with psoriasis between 4% and 20% .
- Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
- Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
- Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
- Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
- Male or female, 18 years of age or older at the time that the consent form was signed.
- Able to complete the study and comply with study instructions.
- Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.
Exclusion criteria:
- Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
- Other serious skin disorder or any chronic medical condition that is not well controlled.
- Female subjects who are pregnant, trying to become pregnant or lactating.
- Any major illness within 30 days prior to the baseline visit.
- Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
Trial location(s)
Location
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, NC, United States, 27157
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-29-06
Actual study completion date
2009-29-06
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
Additional information
Not applicable
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