Clinical Trial: An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours f

Brief Summary: 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.

Detailed Summary:
Sponsor: Cassiopea SpA

Current Primary Outcome: Change in HPA Axis Response as measured by CST [ Time Frame: 14 Days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate Trough Plasma Concentrations [ Time Frame: 14 Days ]

Trough measurements of cortexolone 17α-propionate and cortexolone concentration in plasma at Screening, Baseline, Day 7 and Day 14.


Original Secondary Outcome: Same as current

Information By: Cassiopea SpA

Dates:
Date Received: March 22, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: February 15, 2017
Last Verified: February 2017