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

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: cortexolone 17α-propionate

Registration Number: NCT01831960

Lead Sponsor: Intrepid Therapeutics, Inc.

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 subjects with acne vulgaris ages 12 years or older.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cortexolone 17α-Propionate	cortexolone 17α-propionate	Topical cream, 1.0% concentration, applied every twelve hours

Primary Outcome Measures

Name	Time	Method
Change in HPA Axis Response to Cosyntropin	Baseline and Day 14	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.
PK Profiles (Cmax) of Cortexolone 17α-propionate	Baseline and Day 14	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).
PK Profiles (Cavg) of Cortexolone 17α-propionate	Baseline and Day 14	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).
PK Profiles (AUC) of Cortexolone 17α-propionate	Baseline and Day 14	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 \[0-12 hours\]).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Shideler Clinical Research Center
🇺🇸
Carmel, Indiana, United States
Michigan Center for Research Corp.
🇺🇸
Clinton Township, Michigan, United States
Northwest Clinical Trials, Inc.
🇺🇸
Boise, Idaho, United States