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COMPLETED Phase 3

An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

NCT02682264 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.

Conditions Studied

Interventions

  • DRUG CB-03-01 cream, 1%

Study Locations (20)

California

  • Center for Dermatology and Laser Surgery — Sacramento
  • Rady Childrens Hospital, Pediatric and Adolescent Dermatology — San Diego
  • Southern California Dermatology — Santa Ana
  • Clinical Science Institute — Santa Monica
  • Memorial Research Medical Clinic dba / Orange County Research Center — Tustin

Florida

  • Study Protocol, Inc. — Boynton Beach
  • Tory Sullivan, M.D., P.A. — North Miami Beach
  • Belleair Research Center — Pinellas Park
  • Meridien Research — St. Petersburg
  • MOORE Clinical Research, Inc. — Tampa

Arkansas

  • Johnson Dermatology — Fort Smith
  • Gary M. Petrus, MD PA — Little Rock

Indiana

  • Shideler Clinical Research Center — Carmel
  • The Indiana Clinical Trials Center — Plainfield

Colorado

  • Horizons Clinical Research Center, LLC — Denver

Georgia

  • MedaPhase, Inc. — Newnan

Illinois

  • Arlington Dermatology — Arlington Heights

Kansas

  • Kansas City Dermatology, PA — Overland Park

Trial Details

FieldValue
Enrollment Target 609 participants
Start Date 2016-03-09
Est. Completion 2018-08-31
Phase Phase 3

Sponsor

Cassiopea SpA

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02682264

The ClinicalTrials.gov registry entry for NCT02682264 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 609 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cassiopea SpA, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention — of which CB-03-01 cream, 1% is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02682264 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02682264 about?

NCT02682264 is a clinical study titled "An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris". The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.

What is the current status of trial NCT02682264?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 609 participants. The study started on 2016-03-09. Estimated completion is 2018-08-31.

What conditions does trial NCT02682264 study?

This clinical trial studies the following conditions: Acne Vulgaris. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02682264?

The interventions under investigation include: CB-03-01 cream, 1% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02682264?

This trial is sponsored by Cassiopea SpA, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02682264 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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