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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CB-03-01 cream, 1%
Sponsored by
Cassiopea SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, clascoterone, anti-androgen

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johnson Dermatology
  • Gary M. Petrus, MD PA
  • Center for Dermatology and Laser Surgery
  • Rady Childrens Hospital, Pediatric and Adolescent Dermatology
  • Southern California Dermatology
  • Clinical Science Institute
  • Memorial Research Medical Clinic dba / Orange County Research Center
  • Horizons Clinical Research Center, LLC
  • Study Protocol, Inc.
  • Tory Sullivan, M.D., P.A.
  • Belleair Research Center
  • Meridien Research
  • MOORE Clinical Research, Inc.
  • MedaPhase, Inc.
  • Arlington Dermatology
  • Shideler Clinical Research Center
  • The Indiana Clinical Trials Center
  • Kansas City Dermatology, PA
  • Maryland Laser Skin and Vein Institute
  • Henry Ford Health System
  • MediSearch Clinical Trials
  • Sadick Research Group, LLC
  • Skin Specialty Dermatology
  • DermResearch Center of New York, Inc.
  • Oregon Dermatology and Research Center
  • The Pennsylvania State University and the Milton S. Hershey Medical Center
  • Clinical Partners, LLC
  • Omega Medical Research
  • Greenville Dermatology, LLC
  • International Clinical Research - Tennessee LLC
  • Tennessee Clinical Research Center
  • Westlake Dermatology Clinical Research Center
  • The University of Texas Health Science Center at Houston
  • Austin Institute for Clinical Research, Inc.
  • Texas Dermatology and Laser Specialists
  • Progressive Clinical Research, PA
  • Clinical Research Associates of Tidewater, Inc.
  • Dermatology Associates
  • Premier Clinical Research
  • Site 3521
  • 3520
  • Site 3524
  • Site 3519
  • Site 3526
  • Site 3522
  • Site 9912
  • Site 9911
  • Site 9913
  • Site 4814
  • 4819
  • Site 4822
  • Site 4811
  • 4815
  • Site 4821
  • Site 4823
  • Site 4813
  • Site 4818
  • Site 4812
  • Site 4820
  • Site 4033
  • Site 4034
  • Site 4031
  • Site 4029
  • Site 4028
  • Site 4035
  • Site 4037
  • Site 4030
  • Site 8138
  • Site 8137
  • Site 8136
  • Site 3802
  • Site 3808
  • Site 3804
  • Site 3809

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CB-03-01 cream, 1%

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
Number of participants with any local and systemic treatment emergent AEs (TEAEs)

Secondary Outcome Measures

Full Information

First Posted
February 10, 2016
Last Updated
October 26, 2020
Sponsor
Cassiopea SpA
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1. Study Identification

Unique Protocol Identification Number
NCT02682264
Brief Title
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2016 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cassiopea SpA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, clascoterone, anti-androgen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CB-03-01 cream, 1%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CB-03-01 cream, 1%
Other Intervention Name(s)
cortexolone 17α-propionate, clascoterone (USAN, INN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
Description
Number of participants with any local and systemic treatment emergent AEs (TEAEs)
Time Frame
up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R&D Cassiopea
Organizational Affiliation
Cassiopea SpA
Official's Role
Study Director
Facility Information:
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Gary M. Petrus, MD PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Center for Dermatology and Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Rady Childrens Hospital, Pediatric and Adolescent Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Southern California Dermatology
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Memorial Research Medical Clinic dba / Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Horizons Clinical Research Center, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Study Protocol, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Tory Sullivan, M.D., P.A.
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Belleair Research Center
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Arlington Dermatology
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Kansas City Dermatology, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Maryland Laser Skin and Vein Institute
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Sadick Research Group, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Skin Specialty Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
DermResearch Center of New York, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Pennsylvania State University and the Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Greenville Dermatology, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
International Clinical Research - Tennessee LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Westlake Dermatology Clinical Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Research Associates of Tidewater, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Site 3521
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
3520
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Site 3524
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Site 3519
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Site 3526
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Site 3522
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Site 9912
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Site 9911
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Site 9913
City
Tbilisi
ZIP/Postal Code
9913
Country
Georgia
Facility Name
Site 4814
City
Białystok
Country
Poland
Facility Name
4819
City
Bydgoszcz
Country
Poland
Facility Name
Site 4822
City
Czestochowa
Country
Poland
Facility Name
Site 4811
City
Dąbrówka
Country
Poland
Facility Name
4815
City
Katowice
Country
Poland
Facility Name
Site 4821
City
Kraków
Country
Poland
Facility Name
Site 4823
City
Osielsko
Country
Poland
Facility Name
Site 4813
City
Szczecin
Country
Poland
Facility Name
Site 4818
City
Warszawa
Country
Poland
Facility Name
Site 4812
City
Wrocław
Country
Poland
Facility Name
Site 4820
City
Łódź
Country
Poland
Facility Name
Site 4033
City
Sector 2
State/Province
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Site 4034
City
Sector 2
State/Province
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Site 4031
City
Sector 3
State/Province
Bucharest
ZIP/Postal Code
030303
Country
Romania
Facility Name
Site 4029
City
Sector 6
State/Province
Bucharest
ZIP/Postal Code
062272
Country
Romania
Facility Name
Site 4028
City
Târgovişte
State/Province
Jud. Dambovita
Country
Romania
Facility Name
Site 4035
City
Bucharest
Country
Romania
Facility Name
Site 4037
City
Iaşi
ZIP/Postal Code
700381
Country
Romania
Facility Name
Site 4030
City
Sibiu
Country
Romania
Facility Name
Site 8138
City
Belgrade
ZIP/Postal Code
11050
Country
Serbia
Facility Name
Site 8137
City
Belgrade
ZIP/Postal Code
8137
Country
Serbia
Facility Name
Site 8136
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Site 3802
City
Dnipro
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Site 3808
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Site 3804
City
Kharkiv
ZIP/Postal Code
61038
Country
Ukraine
Facility Name
Site 3809
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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