Clinical trial NCT01831960: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Cassiopea
clascoterone
cortexolone 17α-propionate
anti-androgen
CB-01-03
Lead sponsor: Intrepid Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in HPA Axis Response to Cosyntropin
timeFrame: Baseline and Day 14
measure: PK Profiles (Cmax) of Cortexolone 17α-propionate
timeFrame: Baseline and Day 14
measure: PK Profiles (AUC) of Cortexolone 17α-propionate
timeFrame: Baseline and Day 14
measure: PK Profiles (Cavg) of Cortexolone 17α-propionate
timeFrame: Baseline and Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc.
state: Idaho
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp.
state: Michigan
Study officials:
affiliation: Cassiopea S.p.A.
name: R&D Cassiopea
role: STUDY_DIRECTOR
References: