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Completed

NCT Number: NCT00988637

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

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

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Probity Medical Research, Waterloo, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Vectical™ Ointment weekdays and Clobex® Spray weekends regimen

Drug

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 names: calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%

Clobex® Spray morning and Vectical™ Ointment evening regimen

Drug

Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days

Other names: clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2009
Registry last updated
Aug 1, 2022

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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