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A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

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ClinicalTrials.gov Identifier: NCT02608450
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 708
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 353 355
Completed 287 290
Not Completed 66 65
Reason Not Completed
Lost to Follow-up             39             32
Withdrawal by Subject             21             15
Adverse Event             3             6
Withdrawal by parent             2             3
Lack of Efficacy             0             3
Noncompliance with study drug             0             2
Physician Decision             0             1
Pregnancy             0             1
Progressive disease             1             0
Multiple reasons             0             2
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 353 355 708
Hide Baseline Analysis Population Description
Number of participants is based on the Intent to treat dataset.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 353 participants 355 participants 708 participants
20.0  (6.7) 19.9  (6.8) 19.9  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Female
221
  62.6%
215
  60.6%
436
  61.6%
Male
132
  37.4%
140
  39.4%
272
  38.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 355 participants 708 participants
Hispanic or Latino
94
  26.6%
80
  22.5%
174
  24.6%
Not Hispanic or Latino
259
  73.4%
275
  77.5%
534
  75.4%
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 353 participants 355 participants 708 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.1%
Asian
9
   2.5%
10
   2.8%
19
   2.7%
Native Hawaiian or Other Pacific Islander
2
   0.6%
0
   0.0%
2
   0.3%
Black or African American
31
   8.8%
38
  10.7%
69
   9.7%
White
298
  84.4%
297
  83.7%
595
  84.0%
More than one race
9
   2.5%
7
   2.0%
16
   2.3%
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 353 participants 355 participants 708 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
292
  82.7%
291
  82.0%
583
  82.3%
4 - Severe
61
  17.3%
64
  18.0%
125
  17.7%
[1]
Measure Description: Investigator's Global Assessment (IGA)
Baseline Acne Lesion Counts  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 353 participants 355 participants 708 participants
Non-inflammatory lesions 59.1  (22.2) 60.7  (22.1) 59.9  (22.1)
Inflammatory lesions 42.4  (11.8) 42.9  (12.3) 42.7  (12.1)
Total Lesion Count 101.5  (25.1) 103.6  (26.1) 102.6  (25.6)
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 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 353 355
Measure Type: Number
Unit of Measure: Percentage of participants
18.4 9.0
2.Primary Outcome
Title Change From Baseline in Non-inflammatory Lesion 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 353 355
Mean (95% Confidence Interval)
Unit of Measure: Non-inflammatory Lesions
-19.4
(-22.6 to -16.7)
-13.0
(-15.7 to -10.3)
3.Primary Outcome
Title Change From Baseline in Inflammatory Lesion 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 353 355
Mean (95% Confidence Interval)
Unit of Measure: Inflammatory Lesions
-19.3
(-21.1 to -17.5)
-15.5
(-17.3 to -13.6)
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 353 355
Mean (95% Confidence Interval)
Unit of Measure: Total lesions
-39.1
(-43.0 to -35.1)
-28.8
(-32.6 to -24.9)
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 353 355
Mean (95% Confidence Interval)
Unit of Measure: percent change
-37.0
(-40.9 to -33.2)
-28.4
(-32.3 to -24.6)
6.Secondary Outcome
Title Percent Change From Baseline in Non-inflammatory Lesion (NIL) 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 353 355
Mean (95% Confidence Interval)
Unit of Measure: percent change
-30.6
(-35.6 to -25.7)
-21.6
(-26.4 to -16.8)
7.Secondary Outcome
Title Percent Change From Baseline in Inflammatory Lesion (IL) 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 353 355
Mean (95% Confidence Interval)
Unit of Measure: percent change
-44.8
(-49.0 to -40.5)
-36.5
(-40.8 to -32.2)
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   0/353 (0.00%)      0/355 (0.00%)    
Hide Serious Adverse Events
CB-03-01 Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/353 (0.00%)      1/355 (0.28%)    
Infections and infestations     
Pneumonia  1 [1]  0/353 (0.00%)  0 1/355 (0.28%)  1
1
Term from vocabulary, MedDRA version 18.1
Indicates events were collected by systematic assessment
[1]
The SAE was deemed not related to test article.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.6%
CB-03-01 Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/353 (2.55%)      18/355 (5.07%)    
General disorders     
Application pain  1  1/353 (0.28%)  1 3/355 (0.85%)  4
Infections and infestations     
Nasopharyngitis  1  6/353 (1.70%)  7 12/355 (3.38%)  12
Injury, poisoning and procedural complications     
Application site pruritus  1  2/353 (0.57%)  2 3/355 (0.85%)  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: NCT02608450    
Other Study ID Numbers: CB-03-01/25
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