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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Evaluate Trough Plasma Concentrations [ Time Frame: 14 Days ]
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