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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - Any
Updated:2/13/2019
Start Date:March 9, 2016
End Date:August 31, 2018

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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.

This is 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 will apply 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 will be 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 will treat facial acne per protocol for nine months. Treatment of truncal acne
will be discussed by the investigator and participant. 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 (i.e., face and trunk).

Participants (approximately 600) will be 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.

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
We found this trial at
39
sites
Santa Ana, California 92701
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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Denver, CO
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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911 Park Avenue
New York, New York 10075
212-710-9855
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New York, NY
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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Norfolk, VA
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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San Antonio, TX
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Warwick, RI
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1100 West Central Road
Arlington Heights, Illinois 60005
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Arlington Heights, IL
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Austin, TX
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Boynton Beach, Florida 33437
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Boynton Beach, FL
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Carmel, IN
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Detroit, Michigan 48202
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Detroit, MI
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Fort Smith, Arkansas 72916
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Fort Smith, AR
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Greenville, South Carolina 29607
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Greenville, SC
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Hershey, PA
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Hunt Valley, Maryland 21030
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Johnston, Rhode Island 02919
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Little Rock, Arkansas 72202
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Murfreesboro, Tennessee 37130
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Nashville, Tennessee 37215
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New York, New York 10155
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Newnan, Georgia 30263
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Newnan, GA
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North Miami Beach, Florida 33162
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Overland Park, Kansas 66215
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Overland Park, KS
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Pflugerville, TX
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Pinellas Park, Florida 33781
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Plainfield, Indiana 46168
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Portland, Oregon 97210
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Portland, OR
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Sacramento, California 95819
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1419 Village Drive
Saint Joseph, Missouri 64506
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Saint Joseph, MO
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Saint Petersburg, Florida 33709
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Saint Petersburg, FL
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San Antonio, Texas 78218
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San Diego, CA
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Santa Monica, California 90404
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Seattle, Washington 98101
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Seattle, WA
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Spokane, Washington 99204
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Stony Brook, New York 11790
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Tampa, Florida 33609
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Tampa, FL
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Tustin, CA
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