Clinical trial NCT02720627: An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
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 for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
cortexolone
anti-androgen
Lead sponsor: Cassiopea SpA
Sponsor class: INDUSTRY
First posted: 2016-03-28
Enrollment: 27
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
* Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
* Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
* Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
* Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Exclusion Criteria:

* Patient is pregnant, lactating, or is planning to become pregnant during the study.
* Patient has a Body Mass Index (BMI) for age percentile \> 95%.
* Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
* Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
* Patient is currently enrolled in an investigational drug or device study.
* Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
* Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
* Patient has participated in a previous CB-03-01 study.

Primary outcomes:
measure: Change in HPA Axis Response as Measured by CST
timeFrame: Pre- and Post-CST on Day 14
Secondary outcomes:
measure: Evaluate Trough Plasma Concentrations
timeFrame: 14 Days
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Site 103
state: Arkansas
city: San Diego
country: United States
facility: Site 101
state: California
city: Houston
country: United States
facility: Site 102
state: Texas
city: Czestochowa
country: Poland
facility: Site 4814
city: Katowice
country: Poland
facility: Site 4811
city: Kraków
country: Poland
facility: Site 4813
city: Kraków
country: Poland
facility: Site 4815
city: Rzeszów
country: Poland
facility: Site 4816
city: Szczecin
country: Poland
facility: Site 4812
city: Tarnów
country: Poland
facility: Site 4817
Study officials:
affiliation: Cassiopea SpA
name: R&D Department
role: STUDY_DIRECTOR
References: