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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Desoximetasone spray applied to affected areas twice daily for 28 days
Investigator Site
Hot Springs, Arkansas, United States
Investigator Site
Albuquerque, New Mexico, United States
Investigator Site
Simpsonville, South Carolina, United States
Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression
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
Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis
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
Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis
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).
Time frame: 28 days
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