Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study
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
2 other identifiers
interventional
151
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 19, 2009
CompletedFirst Posted
Study publicly available on registry
November 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
August 5, 2014
CompletedAugust 5, 2014
July 1, 2014
6 months
November 19, 2009
January 31, 2014
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
28 days
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.
Day 28
Secondary Outcomes (3)
Mean Change From Baseline in PGA Score at Day 28 Using the ITT
Day 28
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
Day 28
Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
Day 28
Study Arms (6)
Desoximetasone 0.05% once daily
EXPERIMENTALDesoximetasone topical spray 0.05% administered once daily to affected area
Desoximetasone 0.05% twice daily
EXPERIMENTALDesoximetasone topical spray 0.05% administered twice daily to affected area
Desoximetasone 0.25% once daily
EXPERIMENTALDesoximetasone topical spray 0.25% administered once daily to affected area
Desoximetasone 0.25% twice daily
EXPERIMENTALDesoximetasone topical spray 0.25% administered twice daily to affected area
Vehicle once daily
PLACEBO COMPARATORVehicle administered to affected areas once daily
Vehicle twice daily
PLACEBO COMPARATORVehicle administered to affected areas twice daily
Interventions
Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
Vehicle topical spray administered to affected areas once daily for 28 days
Vehicle topical spray administered to affected areas twice daily for 28 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Investigator Site
Miami, Florida, United States
Investigator Site
Martinez, Georgia, United States
Investigator Site
Olathe, Kansas, United States
Investigator Site
Wichita, Kansas, United States
Investigator Site
Albuquerque, New Mexico, United States
Investigator Site
Cincinnati, Ohio, United States
Investigator Site
Simpsonville, South Carolina, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Taro Pharmaceuticals U.S.A., Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2009
First Posted
November 23, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 5, 2014
Results First Posted
August 5, 2014
Record last verified: 2014-07