Desoximetasone 0.25% spray
DrugDesoximetasone spray applied to affected areas twice daily for 28 days
NCT Number: NCT01043393
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Investigator Site, Hot Springs, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Desoximetasone spray applied to affected areas twice daily for 28 days
Time frame: 28 days
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.
Time frame: 28 days
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
Time frame: 28 days
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).
Sun Pharmaceutical Industries, Inc.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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