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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: Completed Phase 2 study of Acne Vulgaris, sponsored by Cassiopea SpA.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-10-28 |
| Est. Completion | 2018-03-21 |
| Phase | Phase 2 |
What the finished NCT02720627 record still lists
NCT02720627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (90% lower).
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 lists 10 locations in 4 states (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.
Learn More About Clinical Trials
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Where NCT02720627's enrollment target sits among peer trials
27 56th of 67 higher than 12 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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