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A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

Primary Purpose

Plaque-Type Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olux-E Foam
Clobex lotion
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque-Type Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olux-E Foam

Clobex lotion

Arm Description

Olux-E (clobetasol propionate 0.05%) foam

Clobex (clobetasol propionate 0.05%) lotion.

Outcomes

Primary Outcome Measures

At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.

Secondary Outcome Measures

At Least 1 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
At Least a 2 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
At Least a 3 Grade Improvement Psoriasis Grading Scale
Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
At Least 1 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
At Least a 2 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
At Least a 3 Grade Improvement in the Psoriasis Global Assessment
Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
At Least 1 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
At Least a 2 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
At Least a 3 Grade Improvement in Subject's Global Assessment
Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Median Change in Psoriasis Grading Scale
Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Dermatology Quality of Life - Symptoms and Feelings
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Dermatology Quality of Life - Daily Activities
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Dermatology Quality of Life - Leisure
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Dermatology Quality of Life - Work and School
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Dermatology Quality of Life - Personal Relationships
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Dermatology Quality of Life - Treatment
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Total Dermatology Life Quality Index (DLQI) Score
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life
Dermatology Life Quality Index (DLQI) Categories
Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.

Full Information

First Posted
February 25, 2009
Last Updated
April 19, 2012
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00852761
Brief Title
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis
Official Title
A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (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 determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
Detailed Description
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque-Type Psoriasis
Keywords
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olux-E Foam
Arm Type
Experimental
Arm Description
Olux-E (clobetasol propionate 0.05%) foam
Arm Title
Clobex lotion
Arm Type
Active Comparator
Arm Description
Clobex (clobetasol propionate 0.05%) lotion.
Intervention Type
Drug
Intervention Name(s)
Olux-E Foam
Intervention Description
Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.
Intervention Type
Drug
Intervention Name(s)
Clobex lotion
Other Intervention Name(s)
clobetasol lotion, Clobex
Intervention Description
Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15
Primary Outcome Measure Information:
Title
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
Description
Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Time Frame
Baseline to day 15
Secondary Outcome Measure Information:
Title
At Least 1 Grade Improvement Psoriasis Grading Scale
Description
Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
Time Frame
Baseline, days 3 and 8
Title
At Least a 2 Grade Improvement Psoriasis Grading Scale
Description
Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
Time Frame
Baseline, days 3, 8, 15
Title
At Least a 3 Grade Improvement Psoriasis Grading Scale
Description
Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion. The scale is the same as used for the primary outcome (0 through 5).
Time Frame
Baseline, days 3, 8, 15
Title
At Least 1 Grade Improvement in the Psoriasis Global Assessment
Description
Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame
Baseline, days 3, 8, 15
Title
At Least a 2 Grade Improvement in the Psoriasis Global Assessment
Description
Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame
Baseline, days 3, 8, 15
Title
At Least a 3 Grade Improvement in the Psoriasis Global Assessment
Description
Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.
Time Frame
Baseline, days 3, 8, 15
Title
At Least 1 Grade Improvement in Subject's Global Assessment
Description
Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Time Frame
Baseline, days 3, 8, 15
Title
At Least a 2 Grade Improvement in Subject's Global Assessment
Description
Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Time Frame
Baseline, days 3, 8, 15
Title
At Least a 3 Grade Improvement in Subject's Global Assessment
Description
Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.
Time Frame
Baseline, days 3, 8, 15
Title
Median Change in Psoriasis Grading Scale
Description
Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Quality of Life - Symptoms and Feelings
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Quality of Life - Daily Activities
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Quality of Life - Leisure
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Quality of Life - Work and School
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Quality of Life - Personal Relationships
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Quality of Life - Treatment
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Total Dermatology Life Quality Index (DLQI) Score
Description
Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions. Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life
Time Frame
Baseline, Days 3, 8, 15
Title
Dermatology Life Quality Index (DLQI) Categories
Description
Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.
Time Frame
Days 3, 8, 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
Wake Forest University Health Sciences Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis

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