A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

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: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: CB-03-01 cream, 1%; Drug: Vehicle cream

• Study Type: Interventional
• Enrollment (Actual): 708
• Phase: Phase 3

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0159
    • Site 9911
  • Tbilisi, Georgia, 0179
    • Site 9913
  • Tbilisi, Georgia, 0194
    • Site 9912
• Ukraine
  • Dnipro, Ukraine, 49000
    • Site 3802
  • Kharkiv, Ukraine, 31038
    • Site 3804
  • Kharkiv, Ukraine, 61002
    • 3808
  • Kyiv, Ukraine, 01601
    • Site 3801
  • Lviv, Ukraine, 79014
    • 3807
  • Ternopil', Ukraine, 46006
    • Site 3803
  • Zaporizhzhya, Ukraine, 69063
    • Site 3809
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Gary M. Petrus, MD PA
  • California
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc.
    • Los Angeles, California, United States, 90036
      • Vitiligo & Pigmentation Institute of Southern California
    • San Diego, California, United States, 92120
      • San Diego Sports Medicine and Family Health Center
    • 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
    • Boca Raton, Florida, United States, 33434
      • Site 0190
    • Boynton Beach, Florida, United States, 33437
      • Study Protocol, Inc.
    • Miami, Florida, United States, 33125
      • Site 0196
    • Miami, Florida, United States, 33126
      • Site 0197
    • Miami, Florida, United States, 33135
      • Site 0198
    • Miami, Florida, United States, 33145
      • Site 0199
    • Miami, Florida, United States, 33172
      • Site 0191
    • Miami, Florida, United States, 33172
      • Site 0192
    • Miami, Florida, United States, 33176
      • Site 0195
    • North Miami Beach, Florida, United States, 33162
      • Tory Sullivan, M.D., P.A.
    • 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.
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Site 0152
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology, Cosmetic & Laser Surgery
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York, Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • 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
    • 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
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
    • 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.
  • 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

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:

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)	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 Counts	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 Counts	Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Lesion Counts	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	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 (NIL) Counts	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 (IL) Counts	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.	Baseline and Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Site Reactions	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

• Sponsor: Cassiopea SpA
• Investigators: Study Director: R&D Cassiopea, Cassiopea S.p.A.

Publications and helpful links

General Publications

• Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.
• Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.

Helpful Links

• Study Website

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2016
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: acne; anti-androgen; clascoterone
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: CB-03-01/25