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21 Day Cumulative Skin Irritation of RUT058-60

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02198963
Recruitment Status : Completed
First Posted : July 24, 2014
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Pulmatrix Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Irritation/Irritant
Interventions Drug: Hypochlorous acid solution 106 mg/L
Drug: 0.1% (w/v) Sodium Lauryl Sulfate
Drug: 0.9% Physiological Saline, USP
Enrollment 43
Recruitment Details Subjects were recruited and screened at a single US center
Pre-assignment Details  
Arm/Group Title RUT058-60 vs Negative Control vs Positive Control
Hide Arm/Group Description Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.
Period Title: Overall Study
Started 43
Completed 36
Not Completed 7
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             6
Arm/Group Title RUT058-60 vs Negative and Positve Controls
Hide Arm/Group Description All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
35  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
22
  51.2%
Male
21
  48.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants
American Indian or Alaska Native 2
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 1
Latino 2
White 37
Unknown or Not Reported 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin
Hide Description

Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.

Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.

Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites
Arm/Group Title Hypochlorous Acid Solution 106 mg/L-Abraded Sodium Lauryl Sulfate (0.1%) -Abraded Physiological Saline (0.9%), USP-Abraded Hypochlorous Acid Solution 106 mg/L- Non-Abraded Sodium Lauryl Sulfate (0.1%)- Non-Abraded Physiological Saline (0.9%), USP- Non-Abraded
Hide Arm/Group Description:
0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.
0.02 mL of the Positive Control applied to abraded skin sites.
0.02 mL of the Negative Control applied to abraded skin sites.
0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.
0.02 mL of the Positive Control applied to non-abraded skin sites.
0.02 mL of the Negative Control applied to non-abraded skin sites.
Overall Number of Participants Analyzed 36 36 36 36 36 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.00  (0.68) 2.46  (0.55) 1.34  (0.44) 0.58  (0.33) 1.84  (0.58) 0.82  (0.51)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RUT058-60 vs Negative and Positve Controls
Hide Arm/Group Description All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
All-Cause Mortality
RUT058-60 vs Negative and Positve Controls
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
RUT058-60 vs Negative and Positve Controls
Affected / at Risk (%) # Events
Total   0/43 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RUT058-60 vs Negative and Positve Controls
Affected / at Risk (%) # Events
Total   5/43 (11.63%)    
Metabolism and nutrition disorders   
Hypokalemia * 1  3/43 (6.98%)  3
Hyperglycemia * 1  2/43 (4.65%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18
Results from 36 subjects receiving all applications and completing all visits
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure Agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Pullman
Organization: Mercury Street Medical
Phone: (406) 723-1375
EMail: john.pullman@mecurystmed.com
Layout table for additonal information
Responsible Party: Pulmatrix Inc.
ClinicalTrials.gov Identifier: NCT02198963    
Other Study ID Numbers: CP01-117838
130932-304.01 ( Other Identifier: BioScience Laboratories, Inc )
First Submitted: July 18, 2014
First Posted: July 24, 2014
Results First Submitted: August 10, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016