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Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Desoximetasone 0.05% once daily
Desoximetasone 0.05% twice daily
Desoximetasone 0.25% once daily
Desoximetasone 0.25% once daily
Vehicle once daily
Vehicle twice daily
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Topical corticosteroids, Plaque psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • 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:

  • Pregnancy
  • Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
  • History of psoriasis that has been unresponsive to topical corticosteroid therapy.
  • Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
  • Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.
  • Any condition that would place the study patient at undue risk by participation in the study.
  • Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
  • Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug.
  • Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
  • 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.
  • Hormonal contraceptives for less than one complete cycle prior to entering the study.
  • 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

  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Desoximetasone 0.05% once daily

Desoximetasone 0.05% twice daily

Desoximetasone 0.25% once daily

Desoximetasone 0.25% twice daily

Vehicle once daily

Vehicle twice daily

Arm Description

Desoximetasone topical spray 0.05% administered once daily to affected area

Desoximetasone topical spray 0.05% administered twice daily to affected area

Desoximetasone topical spray 0.25% administered once daily to affected area

Desoximetasone topical spray 0.25% administered twice daily to affected area

Vehicle administered to affected areas once daily

Vehicle administered to affected areas twice daily

Outcomes

Primary Outcome Measures

Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.

Secondary Outcome Measures

Mean Change From Baseline in PGA Score at Day 28 Using the ITT
Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.
Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
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 %Body Surface Area Affected the "Rule of Nine" was be used.

Full Information

First Posted
November 19, 2009
Last Updated
July 9, 2014
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT01018134
Brief Title
Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study
Official Title
A Double-Blind, Vehicle-Controlled, Randomized, Dose Ranging, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (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
The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle 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
Keywords
Psoriasis, Topical corticosteroids, Plaque psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desoximetasone 0.05% once daily
Arm Type
Experimental
Arm Description
Desoximetasone topical spray 0.05% administered once daily to affected area
Arm Title
Desoximetasone 0.05% twice daily
Arm Type
Experimental
Arm Description
Desoximetasone topical spray 0.05% administered twice daily to affected area
Arm Title
Desoximetasone 0.25% once daily
Arm Type
Experimental
Arm Description
Desoximetasone topical spray 0.25% administered once daily to affected area
Arm Title
Desoximetasone 0.25% twice daily
Arm Type
Experimental
Arm Description
Desoximetasone topical spray 0.25% administered twice daily to affected area
Arm Title
Vehicle once daily
Arm Type
Placebo Comparator
Arm Description
Vehicle administered to affected areas once daily
Arm Title
Vehicle twice daily
Arm Type
Placebo Comparator
Arm Description
Vehicle administered to affected areas twice daily
Intervention Type
Drug
Intervention Name(s)
Desoximetasone 0.05% once daily
Intervention Description
Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Desoximetasone 0.05% twice daily
Intervention Description
Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Desoximetasone 0.25% once daily
Intervention Description
Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Desoximetasone 0.25% once daily
Intervention Description
Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Vehicle once daily
Intervention Description
Vehicle topical spray administered to affected areas once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Vehicle twice daily
Intervention Description
Vehicle topical spray administered to affected areas twice daily for 28 days
Primary Outcome Measure Information:
Title
Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
Description
The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response
Time Frame
28 days
Title
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
Description
The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in PGA Score at Day 28 Using the ITT
Description
Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.
Time Frame
Day 28
Title
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
Description
Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.
Time Frame
Day 28
Title
Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
Description
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 %Body Surface Area Affected the "Rule of Nine" was be used.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: Pregnancy Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study. History of psoriasis that has been unresponsive to topical corticosteroid therapy. Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis. Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study. Any condition that would place the study patient at undue risk by participation in the study. Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug. Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug. Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. 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. Hormonal contraceptives for less than one complete cycle prior to entering the study. 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.
Facility Information:
Facility Name
Investigator Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
Martinez
State/Province
Georgia
Country
United States
Facility Name
Investigator Site
City
Olathe
State/Province
Kansas
Country
United States
Facility Name
Investigator Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Investigator Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Investigator Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Investigator Site
City
Simpsonville
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

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Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

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