21 Day Cumulative Skin Irritation of RUT058-60

NCT02198963 | Completed Phase 1 Results DMC

• 2 other identifiers: CP01-117838130932-304.01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritation/Irritant

Keywords

Skin irritation potential of RUT058-60.

Outcome Measures

Primary Outcomes (1)

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

  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.

  21 days

Study Arms (3)

Hypochlorous acid Solution 106 mg/L

EXPERIMENTAL

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

0.1% (w/v) Sodium Lauryl Sulfate

ACTIVE COMPARATOR

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

0.9% Physiological Saline, USP

PLACEBO COMPARATOR

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

Interventions

Hypochlorous acid solution 106 mg/L DRUG

test product

Also known as: RUT058-60

Hypochlorous acid Solution 106 mg/L

0.1% (w/v) Sodium Lauryl Sulfate DRUG

positive control

Also known as: SLS

0.1% (w/v) Sodium Lauryl Sulfate

0.9% Physiological Saline, USP DRUG

negative control

Also known as: sterile saline

0.9% Physiological Saline, USP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unwillingness to fulfill the performance requirements of the study

Sponsors & Collaborators

• Pulmatrix Inc.: lead

Study Sites (1)

BioScience Laboratories, Inc.

Butte, Montana, 59701, United States

Location

MeSH Terms

Interventions

Sodium Dodecyl Sulfate

Intervention Hierarchy (Ancestors)

Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Limitations and Caveats

Results from 36 subjects receiving all applications and completing all visits

Results Point of Contact

• Title: Dr. John Pullman
• Organization: Mercury Street Medical

john.pullman@mecurystmed.com

(406) 723-1375

Study Officials

• John Pullman, M.D.

  BioScience Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 24, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-02

Locations

US (1)