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 |
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.
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.
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
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials