Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25) (NCT NCT02608450)
NCT ID: NCT02608450
Last Updated: 2020-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
708 participants
Primary outcome timeframe
Week 12
Results posted on
2020-11-20
Participant Flow
Participant milestones
| Measure |
CB-03-01 Cream
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
355
|
|
Overall Study
COMPLETED
|
287
|
290
|
|
Overall Study
NOT COMPLETED
|
66
|
65
|
Reasons for withdrawal
| Measure |
CB-03-01 Cream
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
39
|
32
|
|
Overall Study
Withdrawal by Subject
|
21
|
15
|
|
Overall Study
Adverse Event
|
3
|
6
|
|
Overall Study
Withdrawal by parent
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Noncompliance with study drug
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Progressive disease
|
1
|
0
|
|
Overall Study
Multiple reasons
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)
Baseline characteristics by cohort
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
Total
n=708 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Baseline IGA
3 - Moderate
|
292 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
583 Participants
n=5 Participants
|
|
Baseline IGA
4 - Severe
|
61 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Baseline Acne Lesion Counts
Non-inflammatory lesions
|
59.1 Lesions
STANDARD_DEVIATION 22.2 • n=5 Participants
|
60.7 Lesions
STANDARD_DEVIATION 22.1 • n=7 Participants
|
59.9 Lesions
STANDARD_DEVIATION 22.1 • n=5 Participants
|
|
Baseline Acne Lesion Counts
Inflammatory lesions
|
42.4 Lesions
STANDARD_DEVIATION 11.8 • n=5 Participants
|
42.9 Lesions
STANDARD_DEVIATION 12.3 • n=7 Participants
|
42.7 Lesions
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Baseline Acne Lesion Counts
Total Lesion Count
|
101.5 Lesions
STANDARD_DEVIATION 25.1 • n=5 Participants
|
103.6 Lesions
STANDARD_DEVIATION 26.1 • n=7 Participants
|
102.6 Lesions
STANDARD_DEVIATION 25.6 • n=5 Participants
|
|
Age, Continuous
|
20.0 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
19.9 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
19.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
94 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
259 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
534 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
298 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
595 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Baseline IGA
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline IGA
2- Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-treat (ITT) population included all randomized subjects.
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.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
|
18.4 Percentage of participants
|
9.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITT population.
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Change From Baseline in Non-inflammatory Lesion Counts
|
-19.4 Non-inflammatory Lesions
Interval -22.6 to -16.7
|
-13.0 Non-inflammatory Lesions
Interval -15.7 to -10.3
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITT population.
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts
|
-19.3 Inflammatory Lesions
Interval -21.1 to -17.5
|
-15.5 Inflammatory Lesions
Interval -17.3 to -13.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Change From Baseline in Total Lesion Counts
|
-39.1 Total lesions
Interval -43.0 to -35.1
|
-28.8 Total lesions
Interval -32.6 to -24.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Percent Change From Baseline in Total Lesion Counts
|
-37.0 percent change
Interval -40.9 to -33.2
|
-28.4 percent change
Interval -32.3 to -24.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population.
Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts
|
-30.6 percent change
Interval -35.6 to -25.7
|
-21.6 percent change
Interval -26.4 to -16.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population.
Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Outcome measures
| Measure |
CB-03-01 Cream
n=353 Participants
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 Participants
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion (IL) Counts
|
-44.8 percent change
Interval -49.0 to -40.5
|
-36.5 percent change
Interval -40.8 to -32.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 4, 8, and 12Local 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).
Outcome measures
Outcome data not reported
Adverse Events
CB-03-01 Cream
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CB-03-01 Cream
n=353 participants at risk
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 participants at risk
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/353 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
0.28%
1/355 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
Other adverse events
| Measure |
CB-03-01 Cream
n=353 participants at risk
CB-03-01 cream, 1% applied twice daily for 12 weeks
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.
|
Vehicle Cream
n=355 participants at risk
Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.7%
6/353 • Number of events 7 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
3.4%
12/355 • Number of events 12 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
|
General disorders
Application pain
|
0.28%
1/353 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
0.85%
3/355 • Number of events 4 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
|
Injury, poisoning and procedural complications
Application site pruritus
|
0.57%
2/353 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
0.85%
3/355 • Number of events 3 • Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least on dose of the test article.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER