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A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

NCT01844739 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-19

No results posted yet for this study

Summary

This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.

Conditions

  • Acne Vulgaris

Interventions

DRUG

NVN1000 4% Gel

Applied topically twice daily

DRUG

Vehicle Gel

Applied topically twice daily

Sponsors & Collaborators

  • Novan, Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce Rico, MD · Novan, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT01844739 on ClinicalTrials.gov