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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02720627
Recruitment Status : Completed
First Posted : March 28, 2016
Results First Posted : October 19, 2020
Last Update Posted : November 20, 2020
Information provided by (Responsible Party):
Cassiopea SpA

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: cortexolone 17α-propionate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris
Actual Study Start Date : October 28, 2016
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: 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
Drug: 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.
Other Name: CB-03-01

Primary Outcome Measures :
  1. Change in HPA Axis Response as Measured by CST [ Time Frame: Pre- and Post-CST on Day 14 ]
    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.

Secondary Outcome Measures :
  1. Evaluate Trough Plasma Concentrations [ Time Frame: 14 Days ]
    Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14.

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720627

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United States, Arkansas
Site 103
Fort Smith, Arkansas, United States, 72916
United States, California
Site 101
San Diego, California, United States, 92037
United States, Texas
Site 102
Houston, Texas, United States, 77030
Site 4814
Czestochowa, Poland
Site 4811
Katowice, Poland
Site 4813
Kraków, Poland
Site 4815
Kraków, Poland
Site 4816
Rzeszów, Poland
Site 4812
Szczecin, Poland
Site 4817
Tarnów, Poland
Sponsors and Collaborators
Cassiopea SpA
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Study Director: R&D Department Cassiopea SpA
  Study Documents (Full-Text)

Documents provided by Cassiopea SpA:
Study Protocol  [PDF] February 18, 2016
Statistical Analysis Plan  [PDF] November 17, 2017

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Responsible Party: Cassiopea SpA
ClinicalTrials.gov Identifier: NCT02720627    
Other Study ID Numbers: CB-03-01/28
First Posted: March 28, 2016    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cassiopea SpA:
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases