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Trial record 28 of 814 for:    Psoriasis 4

Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00988637
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : June 3, 2011
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE October 1, 2009
First Posted Date  ICMJE October 2, 2009
Results First Submitted Date  ICMJE March 30, 2011
Results First Posted Date  ICMJE June 3, 2011
Last Update Posted Date October 2, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2009)
Number of participants who are Clear/Almost Clear of Plaque Psoriasis at Week 4 based on the Overall Disease Severity (ODS), full ordinal scale from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
Change History Complete list of historical versions of study NCT00988637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
  • Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2 [ Time Frame: Baseline to week 2 ]
    Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
  • Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.
  • Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.
  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
  • Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4
  • Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.
  • Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4 [ Time Frame: Baseline and Week 4 ]
    Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "The treatment program was easy to follow" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
  • Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4 [ Time Frame: Week 4 ]
    Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am Satisfied with my Appearance" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
  • Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4 [ Time Frame: Week 4 ]
    Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am satisfied with the results of this treatment program" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
  • Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4 [ Time Frame: Week 4 ]
    Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I would use this treatment program again if recommended by the dermatologist" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
  • Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2009)
  • Number of participants who are Clear/Almost Clear of Plaque Psoriasis at Week 4 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
  • Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
  • Number of participants with decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
  • Percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
  • Mean scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) at Baseline and Week 4 [ Time Frame: Baseline and Week 4 ]
  • Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey questions at Week 4 [ Time Frame: Baseline and Week 4 ]
  • Number of participants with Tolerability Assessments resulting in Adverse Events [ Time Frame: Baseline and Week 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Official Title  ICMJE An Open-label, Multi-center, Randomized, Evaluator-Blinded Study to Evaluate the Safety and Efficacy of Two Treatment Regimens Involving Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05% in the Treatment of Moderate Plaque Psoriasis
Brief Summary

This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

  1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
  2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen
    Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days
    Other Name: calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%
  • Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen
    Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
    Other Name: clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g
Study Arms  ICMJE
  • 1) Vectical™ Ointment and Clobex® Spray
    Vectical™ Ointment weekdays & Clobex® Spray weekends regimen
    Intervention: Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen
  • 2) Clobex® Spray and Vectical™ Ointment
    Clobex® Spray morning and Vectical™ Ointment evening regimen
    Intervention: Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen
Publications *

*   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: March 2, 2010)
138
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2009)
120
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects aged 18 to 80 years inclusive
  • Subjects with an Overall Disease Severity of 3 (moderate)
  • Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin, axillae and/or other intertriginous areas
  • For concurrent medications, type and dose must have been stable for at least 3 months prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator

Exclusion Criteria:

  • Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium
  • Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas
  • Subjects with a wash-out period for topical treatment less than 30 days (Any steroid containing medication, dovonex, anthralin, tar and/or UVB treatment)
  • Subjects with a wash-out period for systemic treatment less than 12 weeks (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)
  • Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
  • Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00988637
Other Study ID Numbers  ICMJE US10144
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date September 2012

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