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

• ClinicalTrials.gov Identifier: NCT00852761
• Recruitment Status: Completed
• First Posted: February 27, 2009
• Results First Posted: October 4, 2011
• Last Update Posted: April 23, 2012
• Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Stiefel, a GSK Company )

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.

Condition or disease	Intervention/treatment	Phase
Plaque-Type Psoriasis	Drug: Olux-E Foam; Drug: Clobex lotion	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
• Study Start Date: March 2009
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: August 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Olux-E Foam; Olux-E (clobetasol propionate 0.05%) foam	Drug: Olux-E Foam; 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.
Active Comparator: Clobex lotion; Clobex (clobetasol propionate 0.05%) lotion.	Drug: Clobex lotion; 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; Other Names: clobetasol lotion; Clobex

Outcome Measures

Primary Outcome Measures :

1. At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale) [ Time Frame: Baseline to day 15 ]
   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 :

1. At Least 1 Grade Improvement Psoriasis Grading Scale [ Time Frame: Baseline, days 3 and 8 ]

   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).

2. At Least a 2 Grade Improvement Psoriasis Grading Scale [ Time Frame: Baseline, days 3, 8, 15 ]

   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).

3. At Least a 3 Grade Improvement Psoriasis Grading Scale [ Time Frame: Baseline, days 3, 8, 15 ]

   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).

4. At Least 1 Grade Improvement in the Psoriasis Global Assessment [ Time Frame: Baseline, days 3, 8, 15 ]
   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.
5. At Least a 2 Grade Improvement in the Psoriasis Global Assessment [ Time Frame: Baseline, days 3, 8, 15 ]
   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.
6. At Least a 3 Grade Improvement in the Psoriasis Global Assessment [ Time Frame: Baseline, days 3, 8, 15 ]
   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.
7. At Least 1 Grade Improvement in Subject's Global Assessment [ Time Frame: Baseline, days 3, 8, 15 ]
   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.
8. At Least a 2 Grade Improvement in Subject's Global Assessment [ Time Frame: Baseline, days 3, 8, 15 ]
   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.
9. At Least a 3 Grade Improvement in Subject's Global Assessment [ Time Frame: Baseline, days 3, 8, 15 ]
   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.
10. Median Change in Psoriasis Grading Scale [ Time Frame: Baseline, Days 3, 8, 15 ]
    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.
11. Dermatology Quality of Life - Symptoms and Feelings [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

12. Dermatology Quality of Life - Daily Activities [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

13. Dermatology Quality of Life - Leisure [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

14. Dermatology Quality of Life - Work and School [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

15. Dermatology Quality of Life - Personal Relationships [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

16. Dermatology Quality of Life - Treatment [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

17. Total Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline, Days 3, 8, 15 ]

    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

18. Dermatology Life Quality Index (DLQI) Categories [ Time Frame: Days 3, 8, 15 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Stiefel, a GSK Company

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: Stiefel, a GSK Company
• ClinicalTrials.gov Identifier: NCT00852761
• Other Study ID Numbers: 114569; U0280-402
• First Posted: February 27, 2009
• Results First Posted: October 4, 2011
• Last Update Posted: April 23, 2012
• Last Verified: April 2012

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):

Psoriasis

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Clobetasol; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs