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21 Day Cumulative Skin Irritation of RUT058-60

NCT02198963 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2016-02-04

Study results available
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Summary

The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects.

Conditions

  • Irritation/Irritant

Interventions

DRUG

Hypochlorous acid solution 106 mg/L

test product

DRUG

0.1% (w/v) Sodium Lauryl Sulfate

positive control

DRUG

0.9% Physiological Saline, USP

negative control

Sponsors & Collaborators

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • John Pullman, M.D. · BioScience Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-08-31
Completion
2014-09-30

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 NCT02198963 on ClinicalTrials.gov