An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
This study has been completed.
Information provided by (Responsible Party):
Intrepid Therapeutics, Inc.
First received: April 11, 2013
Last updated: March 27, 2015
Last verified: March 2015
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.
Drug: cortexolone 17α-propionate
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Change in HPA Axis Response to Cosyntropin [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
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.
- Change in PK profiles of cortexolone 17α-propionate and cortexolone [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
Concentration-time profiles of cortexolone 17α-propionate and its metabolite, cortexolone, in plasma.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Experimental: Cortexolone 17α-Propionate
Topical cream, 1.0% concentration, applied every twelve hours
Drug: cortexolone 17α-propionate
Other Name: CB-03-01
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831960
|Northwest Clinical Trials, Inc.
|Boise, Idaho, United States |
|Shideler Clinical Research Center
|Carmel, Indiana, United States |
|Michigan Center for Research Corp.
|Clinton Township, Michigan, United States |
Intrepid Therapeutics, Inc.
||Syd Dromgoole, Ph.D.
No publications provided
||Intrepid Therapeutics, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 11, 2013
||March 27, 2015
||United States: Food and Drug Administration
Keywords provided by Intrepid Therapeutics, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Sebaceous Gland Diseases