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

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ClinicalTrials.gov Identifier: NCT02608476
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Cassiopea SpA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: CB-03-01 cream, 1%
Drug: Vehicle cream
Enrollment 732
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 369 363
Completed 302 282
Not Completed 67 81
Reason Not Completed
Withdrawal by Subject             30             37
Lost to Follow-up             24             24
Adverse Event             2             8
Withdrawal by Parent/Guardian             5             4
Noncompliance with treatment             1             5
Lack of Efficacy             3             1
Other             0             1
Physician Decision             1             0
Pregnancy             0             1
Progressive disease             1             0
Arm/Group Title CB-03-01 Cream Vehicle Cream Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 369 363 732
Hide Baseline Analysis Population Description
Intent-to-Treat population; defined as all subjects randomized and whom received at least one dose of study medication, including vehicle.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 369 participants 363 participants 732 participants
19.3  (5.6) 19.0  (5.4) 19.2  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 363 participants 732 participants
Female
243
  65.9%
221
  60.9%
464
  63.4%
Male
126
  34.1%
142
  39.1%
268
  36.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 363 participants 732 participants
Hispanic or Latino
20
   5.4%
9
   2.5%
29
   4.0%
Not Hispanic or Latino
349
  94.6%
354
  97.5%
703
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 363 participants 732 participants
American Indian or Alaska Native
1
   0.3%
1
   0.3%
2
   0.3%
Asian
0
   0.0%
4
   1.1%
4
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.1%
Black or African American
7
   1.9%
6
   1.7%
13
   1.8%
White
357
  96.7%
348
  95.9%
705
  96.3%
More than one race
0
   0.0%
1
   0.3%
1
   0.1%
Unknown or Not Reported
4
   1.1%
2
   0.6%
6
   0.8%
Baseline IGA   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 363 participants 732 participants
0 - Clear
0
   0.0%
0
   0.0%
0
   0.0%
1 - Almost Clear
0
   0.0%
0
   0.0%
0
   0.0%
2 - Mild
0
   0.0%
0
   0.0%
0
   0.0%
3 - Moderate
305
  82.7%
313
  86.2%
618
  84.4%
4 - Severe
64
  17.3%
50
  13.8%
114
  15.6%
[1]
Measure Description: Investigator's Global Assessment (IGA)
Baseline Acne Lesion Counts  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 369 participants 363 participants 732 participants
Non-inflammatory lesions 62.8  (21.4) 63.3  (20.5) 63.1  (21.0)
Inflammatory lesions 42.9  (12.2) 41.3  (11.0) 42.1  (11.6)
Total Lesions 105.7  (25.8) 104.6  (24.2) 105.2  (25.0)
1.Primary Outcome
Title Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population, which included all randomized subjects
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Measure Type: Number
Unit of Measure: Percentage of subjects
20.3 6.5
2.Primary Outcome
Title Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Hide Description Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Mean (95% Confidence Interval)
Unit of Measure: Non-inflammatory lesions
-19.4
(-22.1 to -16.7)
-10.8
(-13.6 to -8.0)
3.Primary Outcome
Title Change From Baseline in Inflammatory Lesion (IL) Counts
Hide Description Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Mean (95% Confidence Interval)
Unit of Measure: Inflammatory lesions
-20.0
(-21.7 to -18.3)
-12.6
(-14.3 to -10.8)
4.Secondary Outcome
Title Change From Baseline in Total Lesion Counts
Hide Description Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Mean (95% Confidence Interval)
Unit of Measure: total lesions
-40.0
(-43.8 to -36.2)
-23.6
(-27.8 to -19.5)
5.Secondary Outcome
Title Percent Change From Baseline in Total Lesion Counts
Hide Description Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Mean (95% Confidence Interval)
Unit of Measure: percent change
-37.3
(-41.1 to -33.6)
-22.1
(-26.1 to -18.1)
6.Secondary Outcome
Title Percent Change From Baseline in Non-inflammatory Lesion Counts
Hide Description Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Mean (95% Confidence Interval)
Unit of Measure: percent change
-29.3
(-33.7 to -24.9)
-15.6
(-20.3 to -10.9)
7.Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion Counts
Hide Description Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 369 363
Mean (95% Confidence Interval)
Unit of Measure: percent change
-46.9
(-50.9 to -42.8)
-29.6
(-33.9 to -25.3)
8.Other Pre-specified Outcome
Title Local Site Reactions
Hide Description 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).
Time Frame Baseline, Weeks 4, 8, and 12
Outcome Measure Data Not Reported
Time Frame Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
Adverse Event Reporting Description 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.
 
Arm/Group Title CB-03-01 Cream Vehicle Cream
Hide Arm/Group Description

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 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.

All-Cause Mortality
CB-03-01 Cream Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/369 (0.00%)      0/363 (0.00%)    
Hide Serious Adverse Events
CB-03-01 Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/369 (0.00%)      1/363 (0.28%)    
Vascular disorders     
Haematoma  1  0/369 (0.00%)  0 1/363 (0.28%)  1
1
Term from vocabulary, MedDRA version 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.8%
CB-03-01 Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/369 (5.69%)      34/363 (9.37%)    
Gastrointestinal disorders     
Diarrhoea  1  2/369 (0.54%)  2 3/363 (0.83%)  3
General disorders     
Pyrexia  1  0/369 (0.00%)  0 3/363 (0.83%)  3
Infections and infestations     
Nasopharyngitis  1  3/369 (0.81%)  3 7/363 (1.93%)  10
Upper respiratory tract infection  1  1/369 (0.27%)  1 4/363 (1.10%)  4
Bronchitis  1  3/369 (0.81%)  3 0/363 (0.00%)  0
Nervous system disorders     
Headache  1  4/369 (1.08%)  4 3/363 (0.83%)  3
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea  1  3/369 (0.81%)  3 5/363 (1.38%)  5
Cough  1  0/369 (0.00%)  0 3/363 (0.83%)  3
Oropharyngeal pain  1  4/369 (1.08%)  4 4/363 (1.10%)  6
Skin and subcutaneous tissue disorders     
Acne  1  1/369 (0.27%)  1 3/363 (0.83%)  3
1
Term from vocabulary, MedDRA version 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cassiopea R&D
Organization: Cassiopea, SPA
Phone: +39 02 868 911 24
EMail: r&d@cassiopea.com
Layout table for additonal information
Responsible Party: Cassiopea SpA
ClinicalTrials.gov Identifier: NCT02608476    
Other Study ID Numbers: CB-03-01/26
First Submitted: November 17, 2015
First Posted: November 18, 2015
Results First Submitted: September 23, 2020
Results First Posted: November 20, 2020
Last Update Posted: November 20, 2020