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

NCT02720627 | Completed Phase 2 Results

• 1 other identifier: CB-03-01/28
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Change in HPA Axis Response as Measured by CST

  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.

  Pre- and Post-CST on Day 14

Secondary Outcomes (1)

• Evaluate Trough Plasma Concentrations

  14 Days

Study Arms (1)

CB-03-01 cream, 1%

EXPERIMENTAL

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

Drug: cortexolone 17α-propionate

Interventions

cortexolone 17α-propionate 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.

Also known as: CB-03-01

CB-03-01 cream, 1%

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cassiopea SpA: lead

Study Sites (10)

Site 103

Fort Smith, Arkansas, 72916, United States

Location

Site 101

San Diego, California, 92037, United States

Location

Site 102

Houston, Texas, 77030, United States

Location

Site 4814

Częstochowa, Poland

Location

Site 4811

Katowice, Poland

Location

Site 4813

Krakow, Poland

Location

Site 4815

Krakow, Poland

Location

Site 4816

Rzeszów, Poland

Location

Site 4812

Szczecin, Poland

Location

Site 4817

Tarnów, Poland

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Cassiopea R&D
• Organization: Cassiopea, SpA

r&d@cassiopea.com

+39 02 868 911 24

Study Officials

• R&D Department

  Cassiopea SpA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 28, 2016
• Study Start: October 28, 2016
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: November 20, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); US (3)