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P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

NCT02667444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1330

Last updated 2023-07-24

Study results available
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Summary

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Conditions

  • Acne Vulgaris

Interventions

DRUG

SB204 4%

Applied topically once daily

DRUG

Vehicle Gel

Applied topically one daily

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • Novan, Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce Rico, MD · Novan, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2016-12-31
Completion
2016-12-09

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 NCT02667444 on ClinicalTrials.gov