Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study
This study has been completed.
Sponsor:
Taro Pharmaceuticals USA
Information provided by:
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01043393
First received: January 4, 2010
Last updated: November 4, 2010
Last verified: May 2010
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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:
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Desoximetasone
U.S. FDA Resources
Further study details as provided by Taro Pharmaceuticals USA:
Primary Outcome Measures:
- Cortisol response test [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline in % body surface area (BSA) affected by psoriasis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Change from baseline in physician's global assessment (PGA) score for psoriasis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043393
Locations
| United States, Arkansas | |
| Burke Pharmacuetical Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, South Carolina | |
| Palmetto Clinical Trial Services, LLC | |
| Simpsonville, South Carolina, United States | |
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
| Study Director: | Darin B Brimhall, DO, FACP, CPI | Novum |
More Information
No publications provided
| Responsible Party: | Medical Director, Taro Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT01043393 History of Changes |
| Other Study ID Numbers: | DSXS-0805, Study # 70915005 |
| Study First Received: | January 4, 2010 |
| Last Updated: | November 4, 2010 |
| 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 May 16, 2013