Last updated: 11/04/2018 10:01:52
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle foam
GSK study ID
OEF0701
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis
Trial description: The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with a Target Lesion Global Improvement (TLGI) score of 0, 1, or 2 at Weeks 1, 2, and 4
Timeframe: Weeks 1, 2, and 4
Secondary outcomes:
Number of participants with a TLGI score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
Timeframe: Weeks 1, 2, and 4
Number of participants with a pruritus (overall) score of 0 or 1 at Week 2
Timeframe: Week 2
Number of participants with an erythema score of 0 or 1 at Week 2
Timeframe: Week 2
Number of participants with a scaling score of 0 or 1 at Week 2
Timeframe: Week 2
Number of participants with a plaque thickness score of 0 or 1 at Week 2
Timeframe: Week 2
Number of participants with a score of 0 or 1 for Subject Global Assessment at Week 2
Timeframe: Week 2
Mean percent change from Baseline to Week 2 in pruritus (target lesion)
Timeframe: Baseline (Week 0) and Week 2
Mean percent change from Baseline to Week 2 in percent (%) of body surface area (BSA) affected
Timeframe: Baseline (Week 0) and Week 2
Number of participants with a TLGI score of 0, 1, or 2 at Week 1 and Week 4
Timeframe: Week 1 and Week 4
Number of participants with a pruritus (overall) score of 0 or 1 at Baseline and Week 4
Timeframe: Baseline (Week 0) and Week 4
Number of participants with an erythema score of 0 or 1 at Baseline and Week 4
Timeframe: Baseline (Week 0) and Week 4
Number of participants with a scaling score of 0 or 1 at Baseline and Week 4
Timeframe: Baseline (Week 0) and Week 4
Number of participants with a plaque thickness score of 0 or 1 at Baseline and Week 4
Timeframe: Baseline (Week 0) and Week 4
Number of participants with a score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
Timeframe: Baseline (Week 0) and Week 4
Mean percent change from Baseline to Week 4 in pruritus (target lesion)
Timeframe: Baseline (Week 0) and Week 4
Mean percent change from Baseline to Week 4 in percent (%) of body surface area (BSA) affected
Timeframe: Baseline (Week 0) and Week 4
Interventions:
Drug: Clobetasol propionate foam
Drug: Vehicle foam
Enrollment:
58
Observational study model:
Not applicable
Primary completion date:
2007-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
clobetasol
Collaborators
GlaxoSmithKline
Study date(s)
November 2007 to January 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- Mild to moderate, plaque-type psoriasis
- Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
- Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- Mild to moderate, plaque-type psoriasis
- Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness
- Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Exclusion criteria:
- Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
- Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
- Subjects who have not complied with the proper wash-out periods for prohibited medications
- Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study
- Skin disease/disorder that might interfere with the study related diagnosis or evaluations
- Evidence of recent alcohol or drug abuse
- History of poor cooperation, non-compliance with medical treatment or unreliability
Trial location(s)
Location
Center for Dermatology, Cosmetic and Laser
Fremont, CA, United States, 94538
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-31-12
Actual study completion date
2008-31-01
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website