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NCT02720627 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acne Vulgaris, sponsored by Cassiopea SpA.

Completed
Registry status
Phase 2
Development phase
27
Enrollment target
10
Study locations

NCT02720627 is a Phase 2 study of Acne Vulgaris that has completed, run by Cassiopea SpA. The registered enrollment target is 27 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 4 states.

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The verdict

NCT02720627, a Phase 2 study of Acne Vulgaris, has completed, sponsored by Cassiopea SpA.

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target
10
Study locations

Study 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 Studied

Interventions

  • DRUG cortexolone 17α-propionate

Study Locations (10)

Other

  • Site 4814 - Częstochowa
  • Site 4811 - Katowice
  • Site 4813 - Krakow
  • Site 4815 - Krakow
  • Site 4816 - Rzeszów
  • Site 4812 - Szczecin
  • Site 4817 - Tarnów

Arkansas

  • Site 103 - Fort Smith

California

  • Site 101 - San Diego

Texas

  • Site 102 - Houston

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2016-10-28
Est. Completion 2018-03-21
Phase Phase 2

Sponsor

Cassiopea SpA

6 total trials

What the Registry Record Tells You About NCT02720627

The ClinicalTrials.gov registry entry for NCT02720627 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (90% lower). The listed sponsor is Cassiopea SpA, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which cortexolone 17α-propionate is the first listed.

NCT02720627 reports 10 study locations spanning 4 distinct geographic areas - top geographies include Other, Arkansas, California.

Frequently Asked Questions

What is clinical trial NCT02720627 about?

NCT02720627 is a clinical study titled "An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris". 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 ef...

What is the current status of trial NCT02720627?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2016-10-28. Estimated completion is 2018-03-21.

What conditions does trial NCT02720627 study?

This clinical trial studies the following conditions: Acne Vulgaris.

What interventions are being tested in trial NCT02720627?

The interventions under investigation include: cortexolone 17α-propionate (DRUG).

Who is sponsoring clinical trial NCT02720627?

This trial is sponsored by Cassiopea SpA, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02720627 being conducted?

This trial has 10 study locations across Arkansas, California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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