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: December 19, 2013
Last verified: November 2013

November 19, 2009
December 19, 2013
November 2009
May 2010   (final data collection date for primary outcome measure)
  • Clinical cure: Physician's Global Assessment (PGA)=0 or 1 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Lesion treatment success, score of 0 or 1, for each of the three signs of erythema, scaling, and plaque elevation [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018134 on ClinicalTrials.gov Archive Site
  • Change from baseline in PGA [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline in Total Lesion Severity Score [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline in Affected Body Surface Area [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: Desoximetasone 0.05% once daily
    Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
  • Drug: Desoximetasone 0.05% twice daily
    Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
  • Drug: Desoximetasone 0.25% once daily
    Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
  • Drug: Desoximetasone 0.25% once daily
    Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
  • Drug: Vehicle once daily
    Vehicle topical spray administered to affected areas once daily for 28 days
  • Drug: Vehicle twice daily
    Vehicle topical spray administered to affected areas twice daily for 28 days
  • Experimental: Desoximetasone 0.05% once daily
    Desoximetasone topical spray 0.05% administered once daily to affected area
    Intervention: Drug: Desoximetasone 0.05% once daily
  • Experimental: Desoximetasone 0.05% twice daily
    Desoximetasone topical spray 0.05% administered twice daily to affected area
    Intervention: Drug: Desoximetasone 0.05% twice daily
  • Experimental: Desoximetasone 0.25% once daily
    Desoximetasone topical spray 0.25% administered once daily to affected area
    Intervention: Drug: Desoximetasone 0.25% once daily
  • Experimental: Desoximetasone 0.25% twice daily
    Desoximetasone topical spray 0.25% administered twice daily to affected area
    Intervention: Drug: Desoximetasone 0.25% once daily
  • Placebo Comparator: Vehicle once daily
    Vehicle administered to affected areas once daily
    Intervention: Drug: Vehicle once daily
  • Placebo Comparator: Vehicle twice daily
    Vehicle administered to affected areas twice daily
    Intervention: Drug: Vehicle twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018134
DSXS 0906.00, 70915004
No
Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
Not Provided
Not Provided
Taro Pharmaceuticals USA
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP