Status:
COMPLETED
21 Day Cumulative Skin Irritation of RUT058-60
Lead Sponsor:
Pulmatrix Inc.
Conditions:
Irritation/Irritant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02198963
Start Date
July 1 2014
End Date
September 1 2014
Last Update
February 4 2016
Active Locations (1)
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1
BioScience Laboratories, Inc.
Butte, Montana, United States, 59701