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

NCT ID: NCT01831960

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-11-30

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.

Conditions

Acne Vulgaris

Keywords

Cassiopea; clascoterone; cortexolone 17α-propionate; anti-androgen; CB-01-03

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cortexolone 17α-Propionate

Topical cream, 1.0% concentration, applied every twelve hours

Group Type: EXPERIMENTAL

cortexolone 17α-propionate

Intervention Type: DRUG

Interventions

cortexolone 17α-propionate

Intervention Type: DRUG

Other Intervention Names

CB-03-01; clascoterone (USAN, INN)

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intrepid Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R&D Cassiopea

Role: STUDY_DIRECTOR

Cassiopea S.p.A.

Locations

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

Countries

United States

Other Identifiers

171-7151-202

Identifier Type: -

Identifier Source: org_study_id