A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

October 29, 2020 updated by: Cassiopea SpA

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
732

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 1000
        • Site 3523
      • Sofia, Bulgaria, 1404
        • Site 3525
      • 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
      • Batumi, Georgia, 6010
        • Site 9923
      • Kutaisi, Georgia, 4600
        • Site 9924
      • Tbilisi, Georgia, 0145
        • Site 9921
      • Tbilisi, Georgia, 0177
        • Site 9920
      • Tbilisi, Georgia, 0186
        • Site 9922
      • Zugdidi, Georgia, 2100
        • Site 9925
  • Poland
      • Bydgoszcz, Poland, 85-863
        • 4819
      • Czestochowa, Poland, 15-794
        • Site 4814
      • Czestochowa, Poland, 42-217
        • Site 4822
      • Katowice, Poland, 40-611
        • 4815
      • Katowice, Poland, 62-069
        • Site 4811
      • Kraków, Poland, 30-002
        • Site 4821
      • Kraków, Poland, 40-611
        • Site 4815
      • Kraków, Poland, 70-332
        • Site 4813
      • Osielsko, Poland, 86-031
        • Site 4823
      • Rzeszów, Poland, 61-113
        • Site 4816
      • Szczecin, Poland, 51-685
        • Site 4812
      • Warszawa, Poland, 02-106
        • Site 4818
      • Łódź, Poland, 91-334
        • Site 4820
  • Romania
      • Bucarest, Romania, 010825
        • Site 4036
      • Bucharest, Romania, 011025
        • Site 4035
      • Craiova, Romania, 200642
        • Site 4032
      • Iaşi, Romania, 700381
        • Site 4037
      • Sibiu, Romania, 550245
        • 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
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Clear dermatology & Aesthetic Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Johnson Dermatology
    • California
      • Sacramento, California, United States, 95819
        • Center for Dermatology and Laser Surgery
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Belleair Research Center
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Arlington Dermatology
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Kansas City Dermatology, PA
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Maryland Laser Skin and Vein Institute
    • New York
      • New York, New York, United States, 10155
        • Skin Specialty Dermatology
      • New York, New York, United States, 10075
        • Sadick Research Group, LLC
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • Texas
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research, PA

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
  2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
  3. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].
  4. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
  5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.
  6. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
  3. Subject has greater than two (2) facial nodules.
  4. Subject has nodulocystic acne.
  5. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  6. Subject is currently enrolled in an investigational drug or device study.
  7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
  8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
  9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
  10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
  11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
  12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
  13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
  14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CB-03-01 cream
CB-03-01 cream, 1% applied twice daily for 12 weeks
Drug: CB-03-01 cream, 1%
CB-03-01 (cortexolone 17α-propionate) 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)
Placebo Comparator: Vehicle cream
Vehicle cream applied twice daily for 12 weeks
Drug: Vehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Time Frame: Week 12
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Week 12
Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Time Frame: Baseline and Week 12
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Baseline and Week 12
Change From Baseline in Inflammatory Lesion (IL) Counts
Time Frame: Baseline and Week 12
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Lesion Counts
Time Frame: Baseline and Week 12
Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Baseline and Week 12
Percent Change From Baseline in Total Lesion Counts
Time Frame: Baseline and Week 12
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Baseline and Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts
Time Frame: Baseline and Week 12
Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
Baseline and Week 12
Percent Change From Baseline in Inflammatory Lesion Counts
Time Frame: Baseline and Week 12
Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Baseline and Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Local Site Reactions
Time Frame: Baseline, Weeks 4, 8, and 12
Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).
Baseline, Weeks 4, 8, and 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cassiopea SpA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: R&D Cassiopea, Cassiopea S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CB-03-01/26

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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