Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Applied topically twice daily for two weeks
Applied topically twice daily for two weeks
TI Site #13
Scottsdale, Arizona, United States
TI Site #12
Thousand Oaks, California, United States
TI Site #11
Miami, Florida, United States
TI Site #31
Batumi, Georgia
The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test
A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).
Time frame: Day 15
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TI Site #32
Tbilisi, Georgia
TI Site #23
Lviv, Ukraine
TI Site #22
Rivne, Ukraine
TI Site #21
Zaporizhzhya, Ukraine