CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
cortexolone 17α-propionatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02720627
NCT02720627Phase 2Completed
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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 for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris

Cassiopea SpA·interventional·Posted Mar 28, 2016·Updated Nov 20, 2020

In Brief

A Phase 2 clinical trial evaluating cortexolone 17α-propionate for Acne Vulgaris. Completed, enrolled 27 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesPoland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 28, 2016
Enrollment StartOct 28, 2016
Primary CompletionMar 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.3 years ago

Interventions

cortexolone 17α-propionatedrug

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.