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 Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Irritation/Irritant	Drug: Hypochlorous acid solution 106 mg/L; Drug: 0.1% (w/v) Sodium Lauryl Sulfate; Drug: 0.9% Physiological Saline, USP	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites
• Study Start Date: July 2014
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hypochlorous acid Solution 106 mg/L; Occlusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back.	Drug: Hypochlorous acid solution 106 mg/L; test product; Other Name: RUT058-60
Active Comparator: 0.1% (w/v) Sodium Lauryl Sulfate; Occlusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.	Drug: 0.1% (w/v) Sodium Lauryl Sulfate; positive control; Other Name: SLS
Placebo Comparator: 0.9% Physiological Saline, USP; Occlusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.	Drug: 0.9% Physiological Saline, USP; negative control; Other Name: sterile saline

Outcome Measures

Primary Outcome Measures :

1. Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin [ Time Frame: 21 days ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Subjects may be of either sex, at least 18 years of age and of any race
• Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions, or other disorders on the parascapular skin of the back
• Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria and confirmed by screening laboratory evaluations
• Subjects must read and sign an Informed Consent Form, Subject Confidential Information and Acceptance Criteria, Authorization to Use and Disclose Protected Health Information Form

Exclusion Criteria:

• Known allergies to latex (rubber), metals, ink, tape and/or adhesives, soap, hypochlorous acid, sodium lauryl sulfate, physiological Saline
• Exposure of the upper back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, or strong detergents in the 7 days prior to, or during the 3-week test period; or sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs
• Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period
• A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition, such as AIDS (or HIV positive)
• Pregnancy, plans to become pregnant within the pre-test period or test days of the study, or nursing a child. Women cannot be pregnant, as evidenced by a negative urine pregnancy test, or should be of non-childbearing potential; that is, surgically sterile or postmenopausal (amenorrhea for at least 12 months)
• Any active skin rashes or breaks in the skin of the parascapular region of the back
• Any sunburn or tattoos on the skin of the parascapular region of the back
• A currently active skin disease or inflammatory skin condition, including contact dermatitis
• Participation in a clinical study in the past 7 days or current participation in another clinical study
• Any medical condition or use of any medications that, in the opinion of the Principal Investigator, should preclude participation
• Clinical laboratory assessments that are determined by the Principal Investigator to indicate a clinically relevant abnormality and/or an exclusionary medical condition
• Unwillingness to fulfill the performance requirements of the study

Contacts and Locations

Locations

United States, Montana

BioScience Laboratories, Inc.

Butte, Montana, United States, 59701

Sponsors and Collaborators

Pulmatrix Inc.

Investigators

• Principal Investigator: John Pullman, M.D.; BioScience Laboratories, Inc.

More Information

• Responsible Party: Pulmatrix Inc.
• ClinicalTrials.gov Identifier: NCT02198963
• Other Study ID Numbers: CP01-117838; 130932-304.01 ( Other Identifier: BioScience Laboratories, Inc )
• First Posted: July 24, 2014
• Results First Posted: February 4, 2016
• Last Update Posted: February 4, 2016
• Last Verified: February 2016

Keywords provided by Pulmatrix Inc.:

Skin irritation potential of RUT058-60.