The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
Apply 3.5 grams twice daily for 1-2 weeks
Apply 3.5 grams twice daily for 1-2 weeks
Therapeutics Clinical Research
San Diego, California, United States
Michigan Center for Skin Care Research (dba Skin Care Research)
Clinton Township, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Dermatology, Laser & Vein Specialists of the Carolinas PLLC
Charlotte, North Carolina, United States
Adrenal Suppression Potential
Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.
Time frame: After 1-2 weeks dose
Pharmacokinetic Properties (Cmax)
Comparison of PK results (peak concentration in plasma \[Cmax\]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.
Time frame: Day 8
Pharmacokinetic Properties (Tmax)
Comparison of PK results (time to peak concentration \[Tmax\]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.
Time frame: Day 8
Pharmacokinetic Properties (AUC)
Comparison of PK results (area under the curve \[AUC\] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.
Time frame: Day 8
Changes in Disease Severity (Success)
Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to "success" and "failure" with success defined as a grade of 1 or 0 at the end of treatment (EOT).
Time frame: Day 15
Number of Subjects Whose Signs of Psoriasis Was Designated "Success"
Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) "success" and "failure" with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared \[Day 8 or Day 15\] or end of the assigned treatment period).
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DermResearch Inc.
Austin, Texas, United States
Time frame: Day 15