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Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN

NCT02596074 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-08-03

No results posted yet for this study

Summary

To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).

Conditions

  • Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Interventions

DRUG

Omiganan (CLS001) topical gel

DRUG

Vehicle topical gel

Sponsors & Collaborators

  • Maruho Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • J. (Koos) Burggraaf, MD, PhD · Centre for Human Drug Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-03-07
Completion
2017-07-04

Countries

  • Netherlands

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 NCT02596074 on ClinicalTrials.gov