Trials / Completed
CompletedNCT02720627
An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Cassiopea SpA · Industry
- Sex
- All
- Age
- 9 Years – 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cortexolone 17α-propionate | 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. |
Timeline
- Start date
- 2016-10-28
- Primary completion
- 2018-03-21
- Completion
- 2018-03-21
- First posted
- 2016-03-28
- Last updated
- 2020-11-20
- Results posted
- 2020-10-19
Locations
10 sites across 2 countries: United States, Poland
Source: ClinicalTrials.gov record NCT02720627. Inclusion in this directory is not an endorsement.