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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01206387
First received: September 20, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: Desoximetasone Spray 0.25%
Drug: placebo comparator
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).

  • Treatment Success [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]

    In the Physician Global Assessment of psoriasis is a score based on physician assessment of disease severity averaged over all lesions from baseline and at Day 28. The PGA score were graded for induration, erythema and scaling; range: from 0 (Clear) to 5 (Very Severe).

    The first evaluation was for the change from baseline in TLSS, 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) [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]

    Mean Change from Baseline in TLSS (ITT)

    TLSS of psoriasis is a score based on physician assessment of disease severity averaged over all lesions from baseline and at Day 28. The TLSS score were graded for induration, erythema and scaling; range: from 0 (Clear) to 5 (Very Severe).

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

    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].



Enrollment: 120
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desoximetasone Spray 0.25% Drug: Desoximetasone Spray 0.25%
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Placebo Comparator: placebo Drug: placebo comparator
Placebo administered to affected area twice a day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01206387

Locations
United States, Kansas
Investigator Site
Wichita, Kansas, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01206387     History of Changes
Other Study ID Numbers: DSXS-0808
Study First Received: September 20, 2010
Results First Received: January 22, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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 18, 2014