A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

October 22, 2020 updated by: Intrepid Therapeutics, Inc.

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of 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.
363

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 2

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

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Diego, California, United States, 92123
        • University Clinical Trials
    • Florida
      • Sanford, Florida, United States
        • International Clinical Research - US, LLC
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research Center, Inc.
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Indiana Clinical Trials Center
    • New York
      • Smithtown, New York, United States
        • Marina I. Peredo, M.D., PC
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center - Dept. of Dermatology
    • Rhode Island
      • Johnston, Rhode Island, United States
        • Clinical Partners, LLC
    • Texas
      • College Station, Texas, United States, 77845
        • J & S Studies
      • Houston, Texas, United States, 77030
        • UT Houston Health Science Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia 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

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
  • Subject has provided written and verbal informed consent/assent.
  • Subject has facial acne vulgaris (including the nose).
  • Subject is willing to comply with study instructions and return to the clinic for required visits.
  • Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

  • Subject is pregnant, lactating, or is planning to become pregnant during the study.
  • Subject is currently enrolled in an investigational drug or device study.
  • Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
  • Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial

  • Subject has used any of the following topical anti-acne preparations or procedures on the face:

    • Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
    • Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
    • Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.

  • Subject has used the following systemic anti-acne medications:

    • Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
    • Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
    • Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
    • Retinoid therapy within six months of the initiation of treatment.

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: Low-dose active, BID
low dose of CB-03-01, 0.1% applied twice a day
Drug: CB-03-01
Topical cream, applied once a day
Other Names:
  • clascoterone
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
  • clascoterone
Experimental: Medium-dose active, BID
medium dose of CB-03-01, 0.5% applied twice a day
Drug: CB-03-01
Topical cream, applied once a day
Other Names:
  • clascoterone
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
  • clascoterone
Experimental: High-dose active, QD
high dose of CB-03-01, 1% applied once a day
Drug: CB-03-01
Topical cream, applied once a day
Other Names:
  • clascoterone
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
  • clascoterone
Experimental: High-dose active, BID
high dose of CB-03-01, 1% applied twice a day
Drug: CB-03-01
Topical cream, applied once a day
Other Names:
  • clascoterone
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
  • clascoterone
Placebo Comparator: Vehicle, QD or BID
vehicle cream, applied once or twice a day
Drug: Vehicle
Topical cream, applied once or twice a day

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
Investigator's Global Assessment (IGA) "Success" - Week 12
Time Frame: Baseline and Week 12
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Baseline and Week 12
Inflammatory and Non-Inflammatory Lesion Counts - Week 12
Time Frame: Baseline and Week 12
Absolute change from Baseline in inflammatory and non-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
Inflammatory and Non-Inflammatory Lesion Counts - Week 8
Time Frame: Baseline and Week 8
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
Baseline and Week 8
Percent Change in Lesion Counts - Weeks 8 and 12
Time Frame: Week 8 and Week 12
Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.
Week 8 and Week 12
IGA "Success" - Week 8
Time Frame: Baseline and Week 8
Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
Baseline and Week 8
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Time Frame: Weeks 4, 8, and 12
Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.
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.
Intrepid Therapeutics, Inc.

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.

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

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.
June 1, 2012

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 1, 2014

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 1, 2014

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).
June 27, 2012

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.
June 27, 2012

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.
June 29, 2012

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 16, 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 22, 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.
  • 171-7151-201

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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