Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26) (NCT NCT02608476)

NCT ID: NCT02608476

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: 732 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	369	363
Overall Study COMPLETED	302	282
Overall Study NOT COMPLETED	67	81

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 Withdrawal by Subject	30	37
Overall Study Lost to Follow-up	24	24
Overall Study Adverse Event	2	8
Overall Study Withdrawal by Parent/Guardian	5	4
Overall Study Noncompliance with treatment	1	5
Overall Study Lack of Efficacy	3	1
Overall Study Other	0	1
Overall Study Physician Decision	1	0
Overall Study Pregnancy	0	1
Overall Study Progressive disease	1	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

Baseline characteristics by cohort

Measure	CB-03-01 Cream n=369 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=363 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=732 Participants Total of all reporting groups
Age, Continuous	19.3 years STANDARD_DEVIATION 5.6 • n=5 Participants	19.0 years STANDARD_DEVIATION 5.4 • n=7 Participants	19.2 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	243 Participants n=5 Participants	221 Participants n=7 Participants	464 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	142 Participants n=7 Participants	268 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	9 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	349 Participants n=5 Participants	354 Participants n=7 Participants	703 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	357 Participants n=5 Participants	348 Participants n=7 Participants	705 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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
Baseline IGA 3 - Moderate	305 Participants n=5 Participants	313 Participants n=7 Participants	618 Participants n=5 Participants
Baseline IGA 4 - Severe	64 Participants n=5 Participants	50 Participants n=7 Participants	114 Participants n=5 Participants
Baseline Acne Lesion Counts Non-inflammatory lesions	62.8 lesions STANDARD_DEVIATION 21.4 • n=5 Participants	63.3 lesions STANDARD_DEVIATION 20.5 • n=7 Participants	63.1 lesions STANDARD_DEVIATION 21.0 • n=5 Participants
Baseline Acne Lesion Counts Inflammatory lesions	42.9 lesions STANDARD_DEVIATION 12.2 • n=5 Participants	41.3 lesions STANDARD_DEVIATION 11.0 • n=7 Participants	42.1 lesions STANDARD_DEVIATION 11.6 • n=5 Participants
Baseline Acne Lesion Counts Total Lesions	105.7 lesions STANDARD_DEVIATION 25.8 • n=5 Participants	104.6 lesions STANDARD_DEVIATION 24.2 • n=7 Participants	105.2 lesions STANDARD_DEVIATION 25.0 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat (ITT) population, which 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=369 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=363 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)	20.3 Percentage of subjects	6.5 Percentage of subjects

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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=369 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=363 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 (NIL) Counts	-19.4 Non-inflammatory lesions Interval -22.1 to -16.7	-10.8 Non-inflammatory lesions Interval -13.6 to -8.0

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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=369 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=363 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 (IL) Counts	-20.0 Inflammatory lesions Interval -21.7 to -18.3	-12.6 Inflammatory lesions Interval -14.3 to -10.8

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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=369 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=363 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	-40.0 total lesions Interval -43.8 to -36.2	-23.6 total lesions Interval -27.8 to -19.5

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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=369 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=363 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	-37.3 percent change Interval -41.1 to -33.6	-22.1 percent change Interval -26.1 to -18.1

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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=369 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=363 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 Counts	-29.3 percent change Interval -33.7 to -24.9	-15.6 percent change Interval -20.3 to -10.9

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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=369 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=363 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 Counts	-46.9 percent change Interval -50.9 to -42.8	-29.6 percent change Interval -33.9 to -25.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 4, 8, and 12

Local 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: 21 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	CB-03-01 Cream n=369 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=363 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.
Vascular disorders Haematoma	0.00% 0/369 • 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% 1/363 • 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=369 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=363 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	0.81% 3/369 • 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.	1.9% 7/363 • Number of events 10 • 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.
Infections and infestations Upper respiratory tract infection	0.27% 1/369 • 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.	1.1% 4/363 • 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.
Infections and infestations Bronchitis	0.81% 3/369 • 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.	0.00% 0/363 • 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 Pyrexia	0.00% 0/369 • 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.	0.83% 3/363 • 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.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.81% 3/369 • 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.	1.4% 5/363 • Number of events 5 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/369 • 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.	0.83% 3/363 • 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.
Skin and subcutaneous tissue disorders Acne	0.27% 1/369 • 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.	0.83% 3/363 • 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.
Gastrointestinal disorders Diarrhoea	0.54% 2/369 • 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.	0.83% 3/363 • 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.
Nervous system disorders Headache	1.1% 4/369 • 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.	0.83% 3/363 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.1% 4/369 • 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.	1.1% 4/363 • Number of events 6 • 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

Cassiopea R&D

Cassiopea, SPA

Phone: +39 02 868 911 24

Email: r&d@cassiopea.com

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