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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00852761
First received: February 25, 2009
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Plaque-Type Psoriasis
Drug: Olux-E Foam
Drug: Clobex lotion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, days 3 and 8 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Days 3, 8, 15 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Days 3, 8, 15 ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852761

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

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00852761     History of Changes
Other Study ID Numbers: 114569, U0280-402
Study First Received: February 25, 2009
Results First Received: November 4, 2010
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014