An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris

An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every Twelve Hours for Two Weeks in Subjects 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 subjects with acne vulgaris ages 12 years or older.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States
      • Northwest Clinical Trials, Inc.
  • Indiana
    • Carmel, Indiana, United States
      • Shideler Clinical Research Center
  • Michigan
    • Clinton Township, Michigan, United States
      • Michigan Center for Research Corp.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has moderate to severe facial acne vulgaris as determined by the Investigator's Global Assessment (IGA) and obvious acne on the chest and/or back at study start.
• Subject has facial acne vulgaris (including the nose) with a minimum number of inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum number of non-inflammatory lesions (open and closed comedones) at study start.
• Females must be post-menopausal, surgically sterile or using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
• Subject must be in general good health in the opinion of the investigator, with normal renal function, based on screening physical examination, medical history, and clinical laboratory values.

Exclusion Criteria:

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject is 12-20 years of age and has a Body Mass Index (BMI) for age percentile > 85%.
• Subject is > 20 years of age and has a BMI > 32.0 kg/m2.
• Subject has used tobacco, smoking cessation products, or products containing nicotine within three months prior to study start.
• Except for the use of contraceptives, subject has used any prescription drug or herbal product within 14 days prior to dosing, any non-prescription drug or vitamin or mineral supplements within 7 days prior to study start; any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of study start.
• Subject has used topical anti-acne medications containing retinoids such as tazarotene, adapalene or tretinoin, within four weeks of study start.
• Subject has used the following systemic anti-acne medications: antibiotics within two weeks of study start, spironolactone within four weeks of study start, or retinoid therapy within three months of study start.
• Subject 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.
• Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
• Subject has used light treatments, microdermabrasion or chemical peels to the face, chest and back within eight weeks of study start.
• Subject cannot avoid any type of strenuous exercise (swimming, running, team sports, etc.,) or the use of hot tubs/saunas from study start to the end of the study.
• Subject has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has used topical corticosteroids (including inhaled and intranasal corticosteroids) within two weeks of study start.
• Subject has used systemic corticosteroids (including intramuscular and intralesional injections) within four weeks of study start.
• Subject has an irregular sleep schedule or works night shifts.
• Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to study start.
• Subject tests positive at Screening for human immunodeficiency virus (HIV) or is known to be seropositive for HIV.
• Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
• Subject had major surgery within 30 days prior to study start or plans to have surgery during the study.
• Subject 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: Cortexolone 17α-Propionate; Topical cream, 1.0% concentration, applied every twelve hours	Drug: cortexolone 17α-propionate; Other Names: CB-03-01; clascoterone (USAN, INN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HPA Axis Response to Cosyntropin	Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.	Baseline and Day 14
PK Profiles (Cmax) of Cortexolone 17α-propionate	Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).	Baseline and Day 14
PK Profiles (AUC) of Cortexolone 17α-propionate	Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application [0-12 hours]) and at Day 14 (i.e., Day 14, after last application [0-12 hours]).	Baseline and Day 14
PK Profiles (Cavg) of Cortexolone 17α-propionate	Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).	Baseline and Day 14

Collaborators and Investigators

• Sponsor: Intrepid Therapeutics, Inc.
• Investigators: Study Director: R&D Cassiopea, Cassiopea S.p.A.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: anti-androgen; Cassiopea; clascoterone; cortexolone 17α-propionate; CB-01-03
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 171-7151-202