NCT02198963

21 Day Cumulative Skin Irritation of RUT058-60

Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Pulmatrix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This Cumulative Irritation Evaluation is designed to determine the skin irritation potential of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy human subjects. Abraded skin will be challenged because the Test Product may be used, in practice, on non-intact skin. The primary research objective in this study is determine the skin irritation potential of RUT058-60. This question will be answered based on the observed results acquired evaluating its application to the abraded and non-abraded skin of at least 30 volunteer subjects, on the test product relative to the control readings. A sufficient number of subjects will be recruited into the study to ensure 30 subjects, including both males and females, complete the study. Prior to the first application of test materials, designated skin sites will be abraded using the Tape Stripping Procedure. Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive Control and Negative Control to abraded and non-abraded sites on the skin in the scapular region of each subject's back. The irritation potential of the test materials will be determined over the course of a 21-day challenge period on at least 30 subjects. A test material will be applied to the same site, abraded and non-abraded, on each day for 21 days. The six skin sites will be evaluated visually prior to each patch application and following the final patch removal.

Conditions

• Irritation/Irritant

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-07-24
• Last updated: 2016-02-04
• Results posted: 2016-02-04

Locations

1 site across 1 country: United States