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Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Desoximetasone Spray 0.25%
placebo comparator
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female 18 years of age or older.
  • Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
  • Have a combined total lesion severity score (TLSS) of ≥ 7 for the Target Lesion.
  • Have a plaque elevation score ≥ 3 of (moderate) for the Target Lesion.
  • The Target Lesion must have an area of at least 5 cm².
  • Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion Criteria:

  • Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp.
  • Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy.
  • In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
  • Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
  • Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
  • Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
  • Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
  • Receipt of any drug as part of a research study within 30 days prior to first dosing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    active product

    placebo comparator

    Arm Description

    Desoximetasone Spray 0.25%

    vehicle

    Outcomes

    Primary Outcome Measures

    Clinical Success
    A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).
    Treatment Success
    A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).

    Secondary Outcome Measures

    Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.
    In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges). The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined.
    Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)
    Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT) TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance.
    Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28
    Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis The Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared For the %Body Surface Area Affected the "Rule of Nine" was be used. Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline].

    Full Information

    First Posted
    September 20, 2010
    Last Updated
    May 3, 2017
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01206387
    Brief Title
    Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis
    Official Title
    A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients With Moderate to Severe Plaque Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taro Pharmaceuticals USA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    efficacy study in patients with moderate to severe plaque psoriasis.
    Detailed Description
    A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients with Moderate to Severe Plaque Psoriasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    active product
    Arm Type
    Experimental
    Arm Description
    Desoximetasone Spray 0.25%
    Arm Title
    placebo comparator
    Arm Type
    Placebo Comparator
    Arm Description
    vehicle
    Intervention Type
    Drug
    Intervention Name(s)
    Desoximetasone Spray 0.25%
    Other Intervention Name(s)
    Desoximetasone
    Intervention Description
    Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    placebo comparator
    Other Intervention Name(s)
    vehicle
    Intervention Description
    Placebo administered to affected area twice a day for 28 days
    Primary Outcome Measure Information:
    Title
    Clinical Success
    Description
    A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).
    Time Frame
    28 days
    Title
    Treatment Success
    Description
    A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.
    Description
    In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges). The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined.
    Time Frame
    Baseline and day 28
    Title
    Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)
    Description
    Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT) TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance.
    Time Frame
    Baseline and day 28
    Title
    Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28
    Description
    Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis The Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared For the %Body Surface Area Affected the "Rule of Nine" was be used. Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline].
    Time Frame
    Baseline and day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or non-pregnant, non-lactating female 18 years of age or older. Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA). Have a combined total lesion severity score (TLSS) of ≥ 7 for the Target Lesion. Have a plaque elevation score ≥ 3 of (moderate) for the Target Lesion. The Target Lesion must have an area of at least 5 cm². Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. Exclusion Criteria: Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp. Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis. Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study. Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study. Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study. Receipt of any drug as part of a research study within 30 days prior to first dosing.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novum Pharmaceutical Research Services
    Organizational Affiliation
    http://www.novumprs.com/contact
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28504031
    Citation
    Saleem MD, Negus D, Feldman SR. Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical trial. J Dermatolog Treat. 2018 Feb;29(1):32-35. doi: 10.1080/09546634.2017.1331027. Epub 2017 May 30.
    Results Reference
    derived

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    Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis

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