Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00842153
First received: February 11, 2009
Last updated: December 21, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Clobetasol propionate foam
Drug: Vehicle foam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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 [ Time Frame: Weeks 1, 2, and 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 1, 2, and 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 0) and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) and Week 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 58
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clobetasol Propionate Foam
Topical foam formulation that includes clobetasol propionate (Steroid)
Drug: Clobetasol propionate foam
Topical Clobetasol propionate foam
Other Name: Olux-E
Placebo Comparator: Vehicle Foam
Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.
Drug: Vehicle foam
Vehicle foam does not include the active drug.

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00842153

Locations
United States, California
Center for Dermatology, Cosmetic and Laser
Fremont, California, United States, 94538
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00842153     History of Changes
Other Study ID Numbers: OEF0701
Study First Received: February 11, 2009
Results First Received: December 21, 2011
Last Updated: December 21, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by GlaxoSmithKline:
Psoriasis
Plaque Type 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 August 01, 2014