Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01018134
First received: November 19, 2009
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Desoximetasone 0.05% once daily
Drug: Desoximetasone 0.05% twice daily
Drug: Desoximetasone 0.25% once daily
Drug: Vehicle once daily
Drug: Vehicle twice daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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). [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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). [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

    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.



Enrollment: 151
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desoximetasone 0.05% once daily
Desoximetasone topical spray 0.05% administered once daily to affected area
Drug: Desoximetasone 0.05% once daily
Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
Experimental: Desoximetasone 0.05% twice daily
Desoximetasone topical spray 0.05% administered twice daily to affected area
Drug: Desoximetasone 0.05% twice daily
Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
Experimental: Desoximetasone 0.25% once daily
Desoximetasone topical spray 0.25% administered once daily to affected area
Drug: Desoximetasone 0.25% once daily
Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
Experimental: Desoximetasone 0.25% twice daily
Desoximetasone topical spray 0.25% administered twice daily to affected area
Drug: Desoximetasone 0.25% once daily
Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
Placebo Comparator: Vehicle once daily
Vehicle administered to affected areas once daily
Drug: Vehicle once daily
Vehicle topical spray administered to affected areas once daily for 28 days
Placebo Comparator: Vehicle twice daily
Vehicle administered to affected areas twice daily
Drug: Vehicle twice daily
Vehicle topical spray administered to affected areas twice daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018134

Locations
United States, Florida
Investigator Site
Miami, Florida, United States
United States, Georgia
Investigator Site
Martinez, Georgia, United States
United States, Kansas
Investigator Site
Olathe, Kansas, United States
Investigator Site
Wichita, Kansas, United States
United States, New Mexico
Investigator Site
Albuquerque, New Mexico, United States
United States, Ohio
Investigator Site
Cincinnati, Ohio, United States
United States, South Carolina
Investigator Site
Simpsonville, South Carolina, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01018134     History of Changes
Other Study ID Numbers: DSXS 0906.00, 70915004
Study First Received: November 19, 2009
Results First Received: January 31, 2014
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Psoriasis
Topical corticosteroids
Plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Desoximetasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014