21 Day Cumulative Skin Irritation of RUT058-60
Condition: Irritation/Irritant
Intervention: Hypochlorous acid solution 106 mg/L; 0.1% (w/v) Sodium Lauryl Sulfate; 0.9% Physiological Saline, USP
Intervention description: test product; positive control; negative control
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Skin irritation potential of RUT058-60.

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.
    

Eligibility 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