21 Day Cumulative Skin Irritation of RUT058-60

Completed · Phase 1

Conditions studied: Irritation/Irritant

In brief

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.

Key facts

Study ID

NCT02198963

Run by

Pulmatrix Inc.

People needed

43

Starts

2014-07-01

Expected to finish

2014-09-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• BioScience Laboratories, Inc. — Butte, Montana, United States

Full record on ClinicalTrials.gov

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