21 Day Cumulative Skin Irritation of RUT058-60 (NCT02198963) | Clinical Trial Compass
CompletedPhase 1
21 Day Cumulative Skin Irritation of RUT058-60
United States43 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-tes…
What they're measuring
1
Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin