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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682264
Recruitment Status : Completed
First Posted : February 15, 2016
Results First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cassiopea SpA

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 9, 2016
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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)




Primary Outcome Measures :
  1. Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events [ Time Frame: up to 52 weeks ]
    Number of participants with any local and systemic treatment emergent AEs (TEAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682264


Locations
Show Show 74 study locations
Sponsors and Collaborators
Cassiopea SpA
Investigators
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Study Director: R&D Cassiopea Cassiopea SpA
  Study Documents (Full-Text)

Documents provided by Cassiopea SpA:
Study Protocol  [PDF] September 9, 2015
Statistical Analysis Plan  [PDF] November 27, 2018

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Responsible Party: Cassiopea SpA
ClinicalTrials.gov Identifier: NCT02682264    
Other Study ID Numbers: CB-03-01/27
First Posted: February 15, 2016    Key Record Dates
Results First Posted: November 17, 2020
Last Update Posted: November 17, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cassiopea SpA:
acne
clascoterone
anti-androgen
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases