Trial Outcomes & Findings for 21 Day Cumulative Skin Irritation of RUT058-60 (NCT NCT02198963)

NCT ID: NCT02198963

Last Updated: 2016-02-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

21 days

Results posted on

2016-02-04

Participant Flow

Subjects were recruited and screened at a single US center

Participant milestones

Participant milestones
Measure	RUT058-60 vs Negative Control vs Positive Control 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.
Overall Study STARTED	43
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	RUT058-60 vs Negative Control vs Positive Control 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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	6

Baseline Characteristics

21 Day Cumulative Skin Irritation of RUT058-60

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RUT058-60 vs Negative and Positve Controls n=43 Participants All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
Age, Continuous	35 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants
Race/Ethnicity, Customized Latino	2 participants n=5 Participants
Race/Ethnicity, Customized White	37 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites

Outcome measures

Outcome measures
Measure	Hypochlorous Acid Solution 106 mg/L-Abraded n=36 Participants 0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.	Sodium Lauryl Sulfate (0.1%) -Abraded n=36 Participants 0.02 mL of the Positive Control applied to abraded skin sites.	Physiological Saline (0.9%), USP-Abraded n=36 Participants 0.02 mL of the Negative Control applied to abraded skin sites.	Hypochlorous Acid Solution 106 mg/L- Non-Abraded n=36 Participants 0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.	Sodium Lauryl Sulfate (0.1%)- Non-Abraded n=36 Participants 0.02 mL of the Positive Control applied to non-abraded skin sites.	Physiological Saline (0.9%), USP- Non-Abraded n=36 Participants 0.02 mL of the Negative Control applied to non-abraded skin sites.
Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin	1.00 units on a scale Standard Deviation 0.68	2.46 units on a scale Standard Deviation 0.55	1.34 units on a scale Standard Deviation 0.44	0.58 units on a scale Standard Deviation 0.33	1.84 units on a scale Standard Deviation 0.58	0.82 units on a scale Standard Deviation 0.51

Adverse Events

RUT058-60 vs Negative and Positve Controls

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RUT058-60 vs Negative and Positve Controls n=43 participants at risk All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
Metabolism and nutrition disorders Hypokalemia	7.0% 3/43 • Number of events 3
Metabolism and nutrition disorders Hyperglycemia	4.7% 2/43 • Number of events 2

Additional Information

Dr. John Pullman

Mercury Street Medical

Phone: (406) 723-1375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure Agreement
Publication restrictions are in place

Restriction type: OTHER