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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720627
• Other study ID #: CB-03-01/28
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2016
• Est. completion date: March 21, 2018

Study information

• Verified date: November 2020
• Source: Cassiopea SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• cortexolone 17a-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.

Locations

Country	Name	City	State
Poland	Site 4814	Czestochowa
Poland	Site 4811	Katowice
Poland	Site 4813	Kraków
Poland	Site 4815	Kraków
Poland	Site 4816	Rzeszów
Poland	Site 4812	Szczecin
Poland	Site 4817	Tarnów
United States	Site 103	Fort Smith	Arkansas
United States	Site 102	Houston	Texas
United States	Site 101	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Cassiopea SpA

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HPA Axis Response as Measured by CST	Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level = 18 µg/dL at Day 14.	Pre- and Post-CST on Day 14
Secondary	Evaluate Trough Plasma Concentrations	Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17a-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14.	14 Days