An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris

NCT ID: NCT02720627

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2018-03-21

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 pediatric patients 9 to less than 12 years of age with acne vulgaris. Adrenal suppression effects and systemic safety are an important safety concern. The current study is designed to investigate these potential concerns under maximal use conditions.

Conditions

Acne Vulgaris

Keywords

acne; cortexolone; anti-androgen

Study Design

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

Study Groups

CB-03-01 cream, 1%

Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days

Group Type: EXPERIMENTAL

cortexolone 17α-propionate

Intervention Type: DRUG

CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.

Interventions

cortexolone 17α-propionate

CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.

Intervention Type: DRUG

Other Intervention Names

CB-03-01

Eligibility Criteria

Inclusion Criteria

• Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
• Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
• Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
• Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
• Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Exclusion Criteria

• Patient is pregnant, lactating, or is planning to become pregnant during the study.
• Patient has a Body Mass Index (BMI) for age percentile > 95%.
• Patient 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.
• Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
• Patient is currently enrolled in an investigational drug or device study.
• Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
• Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
• Patient has participated in a previous CB-03-01 study.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cassiopea SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R&D Department

Role: STUDY_DIRECTOR

Cassiopea SpA

Locations

Site 103

Fort Smith, Arkansas, United States

Site 101

San Diego, California, United States

Site 102

Houston, Texas, United States

Site 4814

Częstochowa, , Poland

Site 4811

Katowice, , Poland

Site 4813

Krakow, , Poland

Site 4815

Krakow, , Poland

Site 4816

Rzeszów, , Poland

Site 4812

Szczecin, , Poland

Site 4817

Tarnów, , Poland

Countries

United States; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CB-03-01/28

Identifier Type: -

Identifier Source: org_study_id