Acne Vulgaris
Conditions
Keywords
acne, clascoterone, anti-androgen
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.
Interventions
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.
Sponsors
Cassiopea SpA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events | up to 52 weeks | Number of participants with any local and systemic treatment emergent AEs (TEAEs) |
Countries
Bulgaria, Georgia, Poland, Romania, Serbia, Ukraine, United States
Participant flow
Recruitment details
There were 609 subjects who were rolled over (i.e., enrolled) from the two Phase 3 pivotal studies (CB-03-01/25 \[NCT02608450\] and CB-03-01/26 \[NCT02608476\]) into this long-term, safety study. However, two (2) subjects in the original vehicle cream were not treated with test article and thus were excluded from the study population (Safety set).
Participants by arm
| Arm | Count |
|---|---|
| CB-03-01 Cream, 1% Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, 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.
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. | 317 |
| CB-03-01 Cream, 1% (Vehicle Arm) Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study. | 290 |
| Total | 607 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 0 |
| Overall Study | Lack of Efficacy | 14 | 16 |
| Overall Study | Lost to Follow-up | 49 | 41 |
| Overall Study | Moved abroad and unable to continue | 0 | 3 |
| Overall Study | Noncompliance with study drug | 1 | 4 |
| Overall Study | Pregnancy | 1 | 2 |
| Overall Study | Progressive Disease | 1 | 0 |
| Overall Study | Recovery | 1 | 2 |
| Overall Study | Stopped test article application | 0 | 1 |
| Overall Study | Technical Problems | 0 | 1 |
| Overall Study | Withdrawal by Parent | 6 | 7 |
| Overall Study | Withdrawal by Subject | 56 | 45 |
Baseline characteristics
| Characteristic | CB-03-01 Cream, 1% (Vehicle Arm) | Total | CB-03-01 Cream, 1% |
|---|---|---|---|
| Age, Continuous | 19.3 years STANDARD_DEVIATION 6.7 | 19.2 years STANDARD_DEVIATION 6.3 | 19.2 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 42 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 565 Participants | 290 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 35 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 256 Participants | 539 Participants | 283 Participants |
| Sex: Female, Male Female | 183 Participants | 381 Participants | 198 Participants |
| Sex: Female, Male Male | 107 Participants | 226 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 317 | 0 / 290 |
| other Total, other adverse events | 21 / 317 | 17 / 290 |
| serious Total, serious adverse events | 3 / 317 | 3 / 290 |
Outcome results
Primary
Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
Number of participants with any local and systemic treatment emergent AEs (TEAEs)
Time frame: up to 52 weeks
Population: Safety dataset population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CB-03-01 Cream, 1% | Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events | 58 Participants |
| CB-03-01 Cream, 1% (Vehicle Arm) | Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events | 52 Participants |