drugset / Trial / NCT02720627

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

NCT02720627

Phase 2 Completed 27 enrolled Cassiopea SpA
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-10-28
Primary completion
2018-03-21
Completion
2018-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Clascoterone Small molecule 1 % Topical

Indications