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A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

NCT01631474 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2020-11-16

Study results available
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Summary

CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

CB-03-01

Topical cream, applied once a day

DRUG

Vehicle

Topical cream, applied once or twice a day

DRUG

CB-03-01

Topical cream, applied twice a day

Sponsors & Collaborators

  • Intrepid Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • R&D Cassiopea · Cassiopea S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

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 NCT01631474 on ClinicalTrials.gov