21 Day Cumulative Skin Irritation of RUT058-60

• 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: Pulmatrix Inc.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		RUT058-60 vs Negative and Positve Controls
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
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

Outcome Measures

1. Primary Outcome

Title	Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	RUT058-60 vs Negative and Positve Controls
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	--/--
Serious Adverse Events
	RUT058-60 vs Negative and Positve Controls
	Affected / at Risk (%)	# Events
Total	0/43 (0.00%)
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

Limitations and Caveats

Results from 36 subjects receiving all applications and completing all visits

More Information

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

• Name/Title: Dr. John Pullman
• Organization: Mercury Street Medical
• Phone: (406) 723-1375
• EMail: john.pullman@mecurystmed.com

• 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