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Acne VulgarisPhase 3NCT02682264

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

A Phase 3 study testing CB-03-01 cream, 1% in people with Acne Vulgaris, run by Cassiopea SpA at 74 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 9 years and older
Conditions the study is for
Acne Vulgaris
What is being tested?
CB-03-01 cream, 1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
609 participants
Where
74 sitesin 7 countries
Study dates
9 Mar 2016to 31 Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

74 sites in 7 countries.

74 sites in 7 countries

United States39 sites

  • Arlington Dermatology

    Arlington Heights, Illinois, 60005

  • Westlake Dermatology Clinical Research Center

    Austin, Texas, 78746

  • Study Protocol, Inc.

    Boynton Beach, Florida, 33437

  • Shideler Clinical Research Center

    Carmel, Indiana, 46032

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • Greenville Dermatology, LLC

    Greenville, South Carolina, 29607

  • The Pennsylvania State University and the Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Maryland Laser Skin and Vein Institute

    Hunt Valley, Maryland, 21030

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Gary M. Petrus, MD PA

    Little Rock, Arkansas, 72205

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee, 37130

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215

  • Sadick Research Group, LLC

    New York, New York, 10075

  • Skin Specialty Dermatology

    New York, New York, 10155

  • MedaPhase, Inc.

    Newnan, Georgia, 30263

  • Clinical Research Associates of Tidewater, Inc.

    Norfolk, Virginia, 23507

  • Tory Sullivan, M.D., P.A.

    North Miami Beach, Florida, 33162

  • Kansas City Dermatology, PA

    Overland Park, Kansas, 66215

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas, 78660

  • Belleair Research Center

    Pinellas Park, Florida, 33781

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Center for Dermatology and Laser Surgery

    Sacramento, California, 95819

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Progressive Clinical Research, PA

    San Antonio, Texas, 78229

  • Rady Childrens Hospital, Pediatric and Adolescent Dermatology

    San Diego, California, 92123

  • Southern California Dermatology

    Santa Ana, California, 92701

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Dermatology Associates

    Seattle, Washington, 98101

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Meridien Research

    St. Petersburg, Florida, 33709

  • DermResearch Center of New York, Inc.

    Stony Brook, New York, 11790

  • MOORE Clinical Research, Inc.

    Tampa, Florida, 33609

  • Memorial Research Medical Clinic dba / Orange County Research Center

    Tustin, California, 92780

  • Omega Medical Research

    Warwick, Rhode Island, 02886

Other trials in United States

Poland11 sites

  • Site 4814

    Bialystok

  • 4819

    Bydgoszcz

  • Site 4822

    Częstochowa

  • Site 4811

    Dąbrówka

  • 4815

    Katowice

  • Site 4821

    Krakow

  • Site 4820

    Lodz

  • Site 4823

    Osielsko

  • Site 4813

    Szczecin

  • Site 4818

    Warsaw

  • Site 4812

    Wroclaw

Other trials in Poland

Romania8 sites

  • Site 4035

    Bucharest

  • Site 4037

    Iași, 700381

  • Site 4033

    Sector 2, Bucharest, 020125

  • Site 4034

    Sector 2, Bucharest, 020125

  • Site 4031

    Sector 3, Bucharest, 030303

  • Site 4029

    Sector 6, Bucharest, 062272

  • Site 4030

    Sibiu

  • Site 4028

    Targoviste, Jud. Dambovita

Other trials in Romania

Bulgaria6 sites

  • Site 3521

    Plovdiv, 4000

  • 3520

    Sofia, 1407

  • Site 3524

    Sofia, 1407

  • Site 3519

    Sofia, 1431

  • Site 3526

    Sofia, 1618

  • Site 3522

    Varna, 9010

Other trials in Bulgaria

Ukraine4 sites

  • Site 3802

    Dnipro, 49000

  • Site 3808

    Kharkiv, 61002

  • Site 3804

    Kharkiv, 61038

  • Site 3809

    Zaporizhzhya, 69063

Other trials in Ukraine

Georgia3 sites

  • Site 9912

    Tbilisi, 0114

  • Site 9911

    Tbilisi, 0159

  • Site 9913

    Tbilisi, 9913

Other trials in Georgia

Serbia3 sites

  • Site 8138

    Belgrade, 11050

  • Site 8137

    Belgrade, 8137

  • Site 8136

    Novi Sad, 21000

Other trials in Serbia

About this study

Official title: 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.

Read the 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.

Conditions
Acne Vulgaris
Being tested
CB-03-01 cream, 1%
Keywords
acne, clascoterone, anti-androgen
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CB-03-01 cream, 1%Drug

    Also called cortexolone 17α-propionate, clascoterone (USAN, INN)

    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.

Study groups in NCT02682264
Study groupRoleWhat they receive
CB-03-01 cream, 1%ExperimentalCB-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.
Receives: Drug: CB-03-01 cream, 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events

    Number of participants with any local and systemic treatment emergent AEs (TEAEs)

    Measured: up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2016 (estimated)
  2. Study start9 Mar 2016
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02682264
Sponsor's protocol ID
CB-03-01/27
Status last verified
Oct 2020
First submitted
10 Feb 2016
Last updated
17 Nov 2020
Data monitoring committee
No
Individual data sharing
No

Publications

  • Eichenfield LF, Gold LS, Han J, Hebert AA, Mazzetti A, Moro L, Squittieri N, Thiboutot D. Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris. J Drugs Dermatol. 2024 Jan 1;23(1):1278-1283. doi: 10.36849/JDD.7719.

    PubMed 38206145

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CB-03-01 cream, 1% in people with Acne Vulgaris, run by Cassiopea SpA at 74 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Poland, Romania, Bulgaria, Ukraine and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02682264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.

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