To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
DFD-01 (betamethasone dipropionate) Spray, 0.05%
Site 102
Encino, California, United States
Site 104
Irvine, California, United States
Site 100
San Diego, California, United States
Site 109
Lebanon, New Hampshire, United States
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later
Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test
Time frame: End of Treatment (day 15 or day 28) with recovery 29 days later
Participants With HPA Axis Suppression at Day 29
Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test
Time frame: Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site 107
New York, New York, United States
Site 106
Arlington, Texas, United States
Site 101
Houston, Texas, United States
Site 105
San Antonio, Texas, United States