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.
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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 August 27, 2015
Sebaceous Gland Diseases