An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cortexolone 17α-propionate
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Cassiopea, clascoterone, cortexolone 17α-propionate, anti-androgen, CB-01-03
Eligibility Criteria
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.
Sites / Locations
- Northwest Clinical Trials, Inc.
- Shideler Clinical Research Center
- Michigan Center for Research Corp.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cortexolone 17α-Propionate
Arm Description
Topical cream, 1.0% concentration, applied every twelve hours
Outcomes
Primary Outcome Measures
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.
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).
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]).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01831960
First Posted
April 11, 2013
Last Updated
November 16, 2020
Sponsor
Intrepid Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01831960
Brief Title
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
Official Title
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
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intrepid Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Cassiopea, clascoterone, cortexolone 17α-propionate, anti-androgen, CB-01-03
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cortexolone 17α-Propionate
Arm Type
Experimental
Arm Description
Topical cream, 1.0% concentration, applied every twelve hours
Intervention Type
Drug
Intervention Name(s)
cortexolone 17α-propionate
Other Intervention Name(s)
CB-03-01, clascoterone (USAN, INN)
Primary Outcome Measure Information:
Title
Change in HPA Axis Response to Cosyntropin
Description
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.
Time Frame
Baseline and Day 14
Title
PK Profiles (Cmax) of Cortexolone 17α-propionate
Description
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).
Time Frame
Baseline and Day 14
Title
PK Profiles (AUC) of Cortexolone 17α-propionate
Description
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]).
Time Frame
Baseline and Day 14
Title
PK Profiles (Cavg) of Cortexolone 17α-propionate
Description
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).
Time Frame
Baseline and Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R&D Cassiopea
Organizational Affiliation
Cassiopea S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Clinical Trials, Inc.
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
Country
United States
Facility Name
Michigan Center for Research Corp.
City
Clinton Township
State/Province
Michigan
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
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