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Completed

NCT Number: NCT00852761

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

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.

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Key information

Conditions

Plaque-type Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olux-E Foam

Drug

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.

Clobex lotion

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stiefel, a GSK Company

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2009
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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