Back to resultsEvaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clobetasol propionate foam
Vehicle foam
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Plaque Type Psoriasis
Eligibility 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
Sites / Locations
- Center for Dermatology, Cosmetic and Laser
- Dermatology Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clobetasol Propionate Foam
Vehicle Foam
Arm Description
Topical foam formulation that includes clobetasol propionate (Steroid)
Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.
Outcomes
Primary Outcome Measures
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Secondary Outcome Measures
Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2
Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Number of Participants With an Erythema Score of 0 or 1 at Week 2
The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Number of Participants With a Scaling Score of 0 or 1 at Week 2
The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2
The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2
Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)
Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.
Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected
Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4
Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4
The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4
The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4
The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)
Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.
Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected
Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Full Information
NCT ID
NCT00842153
First Posted
February 11, 2009
Last Updated
October 5, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00842153
Brief Title
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, Plaque Type Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clobetasol Propionate Foam
Arm Type
Experimental
Arm Description
Topical foam formulation that includes clobetasol propionate (Steroid)
Arm Title
Vehicle Foam
Arm Type
Placebo Comparator
Arm Description
Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate foam
Other Intervention Name(s)
Olux-E
Intervention Description
Topical Clobetasol propionate foam
Intervention Type
Drug
Intervention Name(s)
Vehicle foam
Intervention Description
Vehicle foam does not include the active drug.
Primary Outcome Measure Information:
Title
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
Description
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time Frame
Weeks 1, 2, and 4
Secondary Outcome Measure Information:
Title
Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
Description
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time Frame
Weeks 1, 2, and 4
Title
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2
Description
Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Time Frame
Week 2
Title
Number of Participants With an Erythema Score of 0 or 1 at Week 2
Description
The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Time Frame
Week 2
Title
Number of Participants With a Scaling Score of 0 or 1 at Week 2
Description
The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Time Frame
Week 2
Title
Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2
Description
The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Time Frame
Week 2
Title
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2
Description
Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Time Frame
Week 2
Title
Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)
Description
Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.
Time Frame
Baseline (Week 0) and Week 2
Title
Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected
Description
Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Time Frame
Baseline (Week 0) and Week 2
Title
Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4
Description
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time Frame
Week 1 and Week 4
Title
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4
Description
Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Time Frame
Baseline (Week 0) and Week 4
Title
Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4
Description
The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Time Frame
Baseline (Week 0) and Week 4
Title
Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4
Description
The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Time Frame
Baseline (Week 0) and Week 4
Title
Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4
Description
The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Time Frame
Baseline (Week 0) and Week 4
Title
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
Description
Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Time Frame
Baseline (Week 0) and Week 4
Title
Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)
Description
Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with "0=None" and the right side anchored with "10=Very Severe." A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.
Time Frame
Baseline (Week 0) and Week 4
Title
Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected
Description
Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Time Frame
Baseline (Week 0) and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology, Cosmetic and Laser
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
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