An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

• Sponsor: Cassiopea SpA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02682264
• Collaborator: (none)
• Enrollment: 609
• Locations: 74
• Arm: 1
• Actual Duration (Months): 29.7
• Patients Per Site: 8.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: CB-03-01 cream, 1%	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 609 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects With Acne Vulgaris
• Actual Study Start Date: Mar 9, 2016
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: CB-03-01 cream, 1% CB-03-01 (cortexolone 17α-propionate) Cream, 1%, applied 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.

Drug: CB-03-01 cream, 1%; 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.; Other Names: cortexolone 17α-propionate clascoterone (USAN, INN)

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johnson Dermatology	Fort Smith	Arkansas	United States	72916
2	Gary M. Petrus, MD PA	Little Rock	Arkansas	United States	72205
3	Center for Dermatology and Laser Surgery	Sacramento	California	United States	95819
4	Rady Childrens Hospital, Pediatric and Adolescent Dermatology	San Diego	California	United States	92123
5	Southern California Dermatology	Santa Ana	California	United States	92701
6	Clinical Science Institute	Santa Monica	California	United States	90404
7	Memorial Research Medical Clinic dba / Orange County Research Center	Tustin	California	United States	92780
8	Horizons Clinical Research Center, LLC	Denver	Colorado	United States	80220
9	Study Protocol, Inc.	Boynton Beach	Florida	United States	33437
10	Tory Sullivan, M.D., P.A.	North Miami Beach	Florida	United States	33162
11	Belleair Research Center	Pinellas Park	Florida	United States	33781
12	Meridien Research	Saint Petersburg	Florida	United States	33709
13	MOORE Clinical Research, Inc.	Tampa	Florida	United States	33609
14	MedaPhase, Inc.	Newnan	Georgia	United States	30263
15	Arlington Dermatology	Arlington Heights	Illinois	United States	60005
16	Shideler Clinical Research Center	Carmel	Indiana	United States	46032
17	The Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
18	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
19	Maryland Laser Skin and Vein Institute	Hunt Valley	Maryland	United States	21030
20	Henry Ford Health System	Detroit	Michigan	United States	48202
21	MediSearch Clinical Trials	Saint Joseph	Missouri	United States	64506
22	Sadick Research Group, LLC	New York	New York	United States	10075
23	Skin Specialty Dermatology	New York	New York	United States	10155
24	DermResearch Center of New York, Inc.	Stony Brook	New York	United States	11790
25	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
26	The Pennsylvania State University and the Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
27	Clinical Partners, LLC	Johnston	Rhode Island	United States	02919
28	Omega Medical Research	Warwick	Rhode Island	United States	02886
29	Greenville Dermatology, LLC	Greenville	South Carolina	United States	29607
30	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee	United States	37130
31	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
32	Westlake Dermatology Clinical Research Center	Austin	Texas	United States	78746
33	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
34	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas	United States	78660
35	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218
36	Progressive Clinical Research, PA	San Antonio	Texas	United States	78229
37	Clinical Research Associates of Tidewater, Inc.	Norfolk	Virginia	United States	23507
38	Dermatology Associates	Seattle	Washington	United States	98101
39	Premier Clinical Research	Spokane	Washington	United States	99202
40	Site 3521	Plovdiv		Bulgaria	4000
41	3520	Sofia		Bulgaria	1407
42	Site 3524	Sofia		Bulgaria	1407
43	Site 3519	Sofia		Bulgaria	1431
44	Site 3526	Sofia		Bulgaria	1618
45	Site 3522	Varna		Bulgaria	9010
46	Site 9912	Tbilisi		Georgia	0114
47	Site 9911	Tbilisi		Georgia	0159
48	Site 9913	Tbilisi		Georgia	9913
49	Site 4814	Białystok		Poland
50	4819	Bydgoszcz		Poland
51	Site 4822	Czestochowa		Poland
52	Site 4811	Dąbrówka		Poland
53	4815	Katowice		Poland
54	Site 4821	Kraków		Poland
55	Site 4823	Osielsko		Poland
56	Site 4813	Szczecin		Poland
57	Site 4818	Warszawa		Poland
58	Site 4812	Wrocław		Poland
59	Site 4820	Łódź		Poland
60	Site 4033	Sector 2	Bucharest	Romania	020125
61	Site 4034	Sector 2	Bucharest	Romania	020125
62	Site 4031	Sector 3	Bucharest	Romania	030303
63	Site 4029	Sector 6	Bucharest	Romania	062272
64	Site 4028	Târgovişte	Jud. Dambovita	Romania
65	Site 4035	Bucharest		Romania
66	Site 4037	Iaşi		Romania	700381
67	Site 4030	Sibiu		Romania
68	Site 8138	Belgrade		Serbia	11050
69	Site 8137	Belgrade		Serbia	8137
70	Site 8136	Novi Sad		Serbia	21000
71	Site 3802	Dnipro		Ukraine	49000
72	Site 3808	Kharkiv		Ukraine	61002
73	Site 3804	Kharkiv		Ukraine	61038
74	Site 3809	Zaporizhzhya		Ukraine	69063

Sponsors and Collaborators

• Cassiopea SpA

Investigators

• Study Director: R&D Cassiopea, Cassiopea SpA

Study Documents (Full-Text)

• Study Protocol - Sep 9, 2015
• Statistical Analysis Plan - Nov 27, 2018

More Information

Publications

None provided.

• Responsible Party: Cassiopea SpA
• ClinicalTrials.gov Identifier: NCT02682264
• Other Study ID Numbers: CB-03-01/27
• First Posted: Feb 15, 2016
• Last Update Posted: Nov 17, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Cassiopea SpA: acne; clascoterone; anti-androgen
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

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).

Arm/Group Title	CB-03-01 Cream, 1%	CB-03-01 Cream, 1% (Vehicle Arm)
Arm/Group Description	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.	Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
Period Title: Overall Study
STARTED	317	290
COMPLETED	179	168
NOT COMPLETED	138	122

Baseline Characteristics

Arm/Group Title	CB-03-01 Cream, 1%	CB-03-01 Cream, 1% (Vehicle Arm)	Total
Arm/Group Description	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.	Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.	Total of all reporting groups
Overall Participants	317	290	607
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.2 (5.8)	19.3 (6.7)	19.2 (6.3)
Sex: Female, Male (Count of Participants)
Female	198 62.5%	183 63.1%	381 62.8%
Male	119 37.5%	107 36.9%	226 37.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 8.5%	15 5.2%	42 6.9%
Not Hispanic or Latino	290 91.5%	275 94.8%	565 93.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	0 0%	1 0.2%
Asian	6 1.9%	8 2.8%	14 2.3%
Native Hawaiian or Other Pacific Islander	2 0.6%	1 0.3%	3 0.5%
Black or African American	17 5.4%	18 6.2%	35 5.8%
White	283 89.3%	256 88.3%	539 88.8%
More than one race	4 1.3%	6 2.1%	10 1.6%
Unknown or Not Reported	4 1.3%	1 0.3%	5 0.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
Description	Number of participants with any local and systemic treatment emergent AEs (TEAEs)
Time Frame	up to 52 weeks

Outcome Measure Data

Analysis Population Description

Safety dataset population.

Arm/Group Title	CB-03-01 Cream, 1%	CB-03-01 Cream, 1% (Vehicle Arm)
Arm/Group Description	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.	Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
Measure Participants	317	290
Count of Participants [Participants]	58 18.3%	52 17.9%

Adverse Events

Time Frame	Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
Arm/Group Title	CB-03-01 Cream, 1%		CB-03-01 Cream, 1% (Vehicle Arm)
Arm/Group Description	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.		Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
All Cause Mortality
	CB-03-01 Cream, 1%		CB-03-01 Cream, 1% (Vehicle Arm)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/317 (0%)		0/290 (0%)
Serious Adverse Events
	CB-03-01 Cream, 1%		CB-03-01 Cream, 1% (Vehicle Arm)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/317 (0.9%)		3/290 (1%)
Gastrointestinal disorders
Gastroenteritis eosinophilic	1/317 (0.3%)	1	0/290 (0%)	0
General disorders
Fatigue	0/317 (0%)	0	1/290 (0.3%)	1
Nervous system disorders
Dizziness	1/317 (0.3%)	1	0/290 (0%)	0
Psychiatric disorders
Depression	1/317 (0.3%)	1	0/290 (0%)	0
Suicide attempt	1/317 (0.3%)	1	0/290 (0%)	0
Surgical and medical procedures
Abortion induced	0/317 (0%)	0	1/290 (0.3%)	1
Vascular disorders
Coronary artery dissection	0/317 (0%)	0	1/290 (0.3%)	1
Other (Not Including Serious) Adverse Events
	CB-03-01 Cream, 1%		CB-03-01 Cream, 1% (Vehicle Arm)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/317 (6.6%)		17/290 (5.9%)
General disorders
Application site acne	4/317 (1.3%)	4	0/290 (0%)	0
Infections and infestations
Nasopharyngitis	6/317 (1.9%)	7	10/290 (3.4%)	13
Upper respiratory tract infection	7/317 (2.2%)	8	1/290 (0.3%)	1
Respiratory tract infection viral	1/317 (0.3%)	1	4/290 (1.4%)	4
Sinusitis	3/317 (0.9%)	3	2/290 (0.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.