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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Interventions

  • Drug: cortexolone 17α-propionate

Arms, Groups and Cohorts

  • Experimental: Cortexolone 17α-Propionate
    • Topical cream, 1.0% concentration, applied every twelve hours

Clinical Trial Outcome Measures

Primary Measures

  • Change in HPA Axis Response to Cosyntropin
    • Time Frame: 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
    • Time Frame: 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 (AUC) of Cortexolone 17α-propionate
    • Time Frame: 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]).
  • PK Profiles (Cavg) of Cortexolone 17α-propionate
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intrepid Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • R&D Cassiopea, Study Director, Cassiopea S.p.A.

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