Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842153
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : January 30, 2012
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE February 11, 2009
First Posted Date  ICMJE February 12, 2009
Results First Submitted Date  ICMJE December 21, 2011
Results First Posted Date  ICMJE January 30, 2012
Last Update Posted Date October 9, 2017
Study Start Date  ICMJE November 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
Target Lesion Global Improvement score [ Time Frame: All visits ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
Pruritus, erythmema, scaling, plaque thickness score at Week 2 [ Time Frame: All visits ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Official Title  ICMJE A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Clobetasol propionate foam
    Topical Clobetasol propionate foam
    Other Name: Olux-E
  • Drug: Vehicle foam
    Vehicle foam does not include the active drug.
Study Arms  ICMJE
  • Experimental: Clobetasol Propionate Foam
    Topical foam formulation that includes clobetasol propionate (Steroid)
    Intervention: Drug: Clobetasol propionate foam
  • Placebo Comparator: Vehicle Foam
    Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.
    Intervention: Drug: Vehicle foam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2009)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842153
Other Study ID Numbers  ICMJE OEF0701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP