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

October 26, 2020 updated by: Cassiopea SpA

An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a multicenter, open label, long-term extension study for CB-03-01 cream, 1% focused on safety in male and female participants, 9 years or older who completed one of the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26]. Participants applies the active medication (CB-03-01 cream, 1%) twice daily to the entire face and, if designated by investigator AND desired by the participant, truncal acne for nine additional months of treatment. Thus, overall participants were exposed to CB-03-01 cream, 1% for a total treatment of up to 12 months (0 or 3 months in the Phase 3 pivotal study and an additional nine months in this long-term safety study).

Participants treated facial acne per protocol for nine months. Treatment of truncal acne was discussed by the investigator and participant. Treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk).

Participants were rolled over from the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.

Study Type

Interventional

Enrollment (Actual)

609

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Site 3521
      • Sofia, Bulgaria, 1407
        • 3520
      • Sofia, Bulgaria, 1407
        • Site 3524
      • Sofia, Bulgaria, 1431
        • Site 3519
      • Sofia, Bulgaria, 1618
        • Site 3526
      • Varna, Bulgaria, 9010
        • Site 3522
  • Georgia
      • Tbilisi, Georgia, 0114
        • Site 9912
      • Tbilisi, Georgia, 0159
        • Site 9911
      • Tbilisi, Georgia, 9913
        • Site 9913
  • Poland
      • Białystok, Poland
        • Site 4814
      • Bydgoszcz, Poland
        • 4819
      • Czestochowa, Poland
        • Site 4822
      • Dąbrówka, Poland
        • Site 4811
      • Katowice, Poland
        • 4815
      • Kraków, Poland
        • Site 4821
      • Osielsko, Poland
        • Site 4823
      • Szczecin, Poland
        • Site 4813
      • Warszawa, Poland
        • Site 4818
      • Wrocław, Poland
        • Site 4812
      • Łódź, Poland
        • Site 4820
  • Romania
      • Bucharest, Romania
        • Site 4035
      • Iaşi, Romania, 700381
        • Site 4037
      • Sibiu, Romania
        • Site 4030
    • Bucharest
      • Sector 2, Bucharest, Romania, 020125
        • Site 4033
      • Sector 2, Bucharest, Romania, 020125
        • Site 4034
      • Sector 3, Bucharest, Romania, 030303
        • Site 4031
      • Sector 6, Bucharest, Romania, 062272
        • Site 4029
    • Jud. Dambovita
      • Târgovişte, Jud. Dambovita, Romania
        • Site 4028
  • Serbia
      • Belgrade, Serbia, 11050
        • Site 8138
      • Belgrade, Serbia, 8137
        • Site 8137
      • Novi Sad, Serbia, 21000
        • Site 8136
  • Ukraine
      • Dnipro, Ukraine, 49000
        • Site 3802
      • Kharkiv, Ukraine, 61002
        • Site 3808
      • Kharkiv, Ukraine, 61038
        • Site 3804
      • Zaporizhzhya, Ukraine, 69063
        • Site 3809
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Johnson Dermatology
      • Little Rock, Arkansas, United States, 72205
        • Gary M. Petrus, MD PA
    • California
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
      • San Diego, California, United States, 92123
        • Rady Childrens Hospital, Pediatric and Adolescent Dermatology
      • Santa Ana, California, United States, 92701
        • Southern California Dermatology
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Tustin, California, United States, 92780
        • Memorial Research Medical Clinic dba / Orange County Research Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Study Protocol, Inc.
      • North Miami Beach, Florida, United States, 33162
        • Tory Sullivan, M.D., P.A.
      • Pinellas Park, Florida, United States, 33781
        • Belleair Research Center
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33609
        • MOORE Clinical Research, Inc.
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase, Inc.
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Arlington Dermatology
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Shideler Clinical Research Center
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Kansas City Dermatology, PA
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Maryland Laser Skin and Vein Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Medisearch Clinical Trials
    • New York
      • New York, New York, United States, 10155
        • Skin Specialty Dermatology
      • New York, New York, United States, 10075
        • Sadick Research Group, LLC
      • Stony Brook, New York, United States, 11790
        • DermResearch Center of New York, Inc.
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • The Pennsylvania State University and the Milton S. Hershey Medical Center
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Greenville Dermatology, LLC
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research - Tennessee LLC
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Austin, Texas, United States, 78746
        • Westlake Dermatology Clinical Research Center
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc.
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research, PA
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant has successfully completed participation in one of the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26].
  • Participant agrees to use effective method of contraception throughout study, if applicable.
  • Participant has provided written informed consent or assent.
  • Participant is willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

  • Participant is pregnant, lactating, or is planning to become pregnant during the study.
  • Participant has any skin disease or condition that could interfere with the safety evaluation of the test products or requires the use of interfering topical or systemic therapy.
  • Participant has any condition which, in the investigator's opinion, would make it unsafe or unsuitable for the participant to participate in this research study.
  • Participant plans to use any other investigational drug or device during participation in this study.
  • Participant has known hypersensitivity or previous allergic reaction to the drug or any of its ingredients.
  • Participant is or plans to use any restricted systemic and/or topical anti-acne preparations or medications during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CB-03-01 cream, 1%
CB-03-01 (cortexolone 17α-propionate) Cream, 1%, applied twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Drug: CB-03-01 cream, 1%
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Other Names:
  • cortexolone 17α-propionate
  • clascoterone (USAN, INN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
Time Frame: up to 52 weeks
Number of participants with any local and systemic treatment emergent AEs (TEAEs)
up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cassiopea SpA

Investigators

  • Study Director: R&D Cassiopea, Cassiopea SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2016

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB-03-01/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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