Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
Status:
Terminated
Trial end date:
2019-08-12
Target enrollment:
Participant gender:
Summary
The objective of this open-label multicentric study is to determine the adrenal suppression
potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice
daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque
psoriasis. Subject enrollment will continue until at least 20 subjects with both screening
and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have
completed the study without any significant protocol violations (evaluable subjects). This
may require the enrollment of approximately 25 subjects.