Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01043393
First received: January 4, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The objective of this study is to evaluate the potential of desoximetasone 0.25% topical spray to suppress HPA axis function. The potential for adrenal suppression will be assessed following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters and to evaluate the adverse event (AE) profile.


Condition Intervention Phase
Psoriasis
Drug: Desoximetasone 0.25% spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Safety/Efficacy Study to Assess the Potential for Adrenal Suppression Following Multiple Dosing With 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:
  • Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.


Secondary Outcome Measures:
  • Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis [ Time Frame: 28 days ] [ 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


  • Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).


Enrollment: 24
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psoriasis involving 10-15% BSA
Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.
Drug: Desoximetasone 0.25% spray
Desoximetasone spray applied to affected areas twice daily for 28 days
Experimental: Psoriasis involving >15% of BSA
Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area.
Drug: Desoximetasone 0.25% spray
Desoximetasone spray applied 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 with the extent of BSA affected as designated for each group
  • Group 1: involvement of 10-15% of their BSA
  • Group 2: involvement of > 15% of their BSA
  • Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
  • Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response. Patients must fulfill all of these stipulations:

Exclusion Criteria:

  • Female who is pregnant, nursing, planning to become pregnant during the duration of the study, or if of child bearing potential and sexually active not prepared to use appropriate contraceptive methods to avoid pregnancy.
  • Patient has current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind on the face or scalp that will require active treatment during the study.
  • 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 a history of an adverse reaction to CortrosynTM or similar test reagents.
  • Patient has a significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation in the study.
  • Patient is currently receiving or has received any radiation therapy, anti-neoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
  • Patient has undergone treatment with any systemic or photo antipsoriatic therapy within 8 weeks of the first dose of study drug.
  • 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.
  • 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
  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: NCT01043393

Locations
United States, Arkansas
Investigator Site
Hot Springs, Arkansas, United States
United States, New Mexico
Investigator Site
Albuquerque, New Mexico, 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: NCT01043393     History of Changes
Other Study ID Numbers: DSXS-0805, Study # 70915005
Study First Received: January 4, 2010
Results First Received: January 22, 2014
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Plaque psoriasis

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

ClinicalTrials.gov processed this record on July 22, 2014