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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

NCT02682264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2020-11-17

Study results available
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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.

Conditions

  • Acne Vulgaris

Interventions

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.

Sponsors & Collaborators

  • Cassiopea SpA

    lead INDUSTRY

Principal Investigators

  • R&D Cassiopea · Cassiopea SpA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-09
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States
  • Bulgaria
  • Georgia
  • Poland
  • Romania
  • Serbia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682264 on ClinicalTrials.gov