This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris. Adrenal suppression effects and systemic safety are an important safety concern. The current study is designed to investigate these potential concerns under maximal use conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
Site 103
Fort Smith, Arkansas, United States
Site 101
San Diego, California, United States
Site 102
Houston, Texas, United States
Site 4814
Częstochowa, Poland
Change in HPA Axis Response as Measured by CST
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
Time frame: Pre- and Post-CST on Day 14
Evaluate Trough Plasma Concentrations
Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14.
Time frame: 14 Days
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Site 4811
Katowice, Poland
Site 4813
Krakow, Poland
Site 4815
Krakow, Poland
Site 4816
Rzeszów, Poland
Site 4812
Szczecin, Poland
Site 4817
Tarnów, Poland