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

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: cortexolone 17α-propionate

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Czestochowa, Poland
    • Site 4814
  • Katowice, Poland
    • Site 4811
  • Kraków, Poland
    • Site 4813
  • Kraków, Poland
    • Site 4815
  • Rzeszów, Poland
    • Site 4816
  • Szczecin, Poland
    • Site 4812
  • Tarnów, Poland
    • Site 4817
• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Site 103
  • California
    • San Diego, California, United States, 92037
      • Site 101
  • Texas
    • Houston, Texas, United States, 77030
      • Site 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CB-03-01 cream, 1%; Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days	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.; Other Names: CB-03-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Trough Plasma Concentrations	Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14.	14 Days

Collaborators and Investigators

• Sponsor: Cassiopea SpA
• Investigators: Study Director: R&D Department, Cassiopea SpA

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2016
• Primary Completion (Actual): March 21, 2018
• Study Completion (Actual): March 21, 2018

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: acne; cortexolone; anti-androgen
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: CB-03-01/28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No